,,ii #aadth ,,congress #ast ,session ,s4 #aiac ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,july #cj1 #bjae ,mr4 ,toomey 7for himself1 ,mr4 ,brown1 ,mr4 ,portman1 and ,mr4 ,kaine7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to amend title ,,xviii of the ,social ,security ,act to establish programs to prevent prescription drug abuse under the ,medicare program1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,stopping ,medication ,abuse and ,protecting ,seniors ,act of #bjae4 #b4 ,programs to prevent prescription drug abuse under the ,medicare program 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-#ajd7;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 7or prescribers7 selected under subparagraph 7,d71 and dispensed for such beneficiary by a pharmacy 7or pharmacies7 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 abuse1 as described in subparagraph 7,c77iv74 7ii7 ,initial notice ,an initial written 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 information1 when possible1 describing ,state and ,federal public health resources that are designed to address prescription drug abuse to which the beneficiary may have access1 including substance use disorder treatment services1 addiction treatment services1 mental health services1 and other counseling services2 7,,iii7 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,,iv7 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,v7 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 7,,vi7 contact information for other organizations that can provide the beneficiary with information regarding drug management program for at-risk beneficiaries 7similar to the information provided by the ,secretary in other standardized notices to part ,d eligible individuals enrolled in prescription drug plans under this part72 and 7,,vii7 notice that the beneficiary has a right to an appeal pursuant to subparagraph 7,e74 7iii7 ,second notice ,a second written 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 has been sent1 or informed of1 such identification in the initial notice and is now 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 right of the beneficiary to a reconsideration and an appeal under subsection 7h7 of such identification and the prescribers and pharmacies selected2 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 sponsor in order to submit to the ,,pdp sponsor the preferences described in subclause 7,v74 7iv7 ,timing of notices 7,i7 ,in general ,subject to subclause 7,,ii71 a second written notice described in clause 7iii7 shall be provided to the beneficiary on a date that is not less than #cj 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,,iii7 ,form of notice ,the written notices under clauses 7ii7 and 7iii7 shall be in a format determined appropriate by the ,secretary1 taking into account beneficiary preferences4 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 criteria developed by the ,secretary in consultation with ,,pdp sponsors and other stakeholders described in subsection section #b7;g77#b77;,a7 of the ,stopping ,medication ,abuse and ,protecting ,seniors ,act of #bjae based on clinical factors indicating misuse or abuse of prescription drugs described in subparagraph 7,g71 including dosage1 quantity1 duration of use1 number of prescribers1 and number of pharmacies used to obtain such drug2 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 a prescription drug plan in which such individual was 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 receives hospice care under this title2 7,,ii7 resides in a long-term care facility1 a facility described in section #aije7;d71 or other facility under contract with a single pharmacy2 or 7,,iii7 the ,secretary elects to treat as an exempted individual for purposes of clause 7i74 7iii7 ,program size ,the ,secretary shall establish policies1 including the criteria developed under clause 7i77,i7 and the exemptions under clause 7ii77,,iii71 to ensure that the population of enrollees in a drug management program for at-risk beneficiaries operated by a prescription drug plan can be effectively managed by such plans4 7iv7 ,clinical contact ,with respect to each at-risk beneficiary for prescription drug abuse enrolled in a prescription drug plan offered by a ,,pdp sponsor1 the ,,pdp sponsor shall contact the beneficiary's physicians regarding whether prescribed medications are appropriate for such beneficiary's medical conditions4 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,,iii7 and 7iii77,v7 of subparagraph 7,b7 if applicable1 select-- 7,i7 one1 or1 if the ,,pdp sponsor reasonably determines it necessary to provide the beneficiary with reasonable access under clause 7ii71 more than one1 individual who is authorized to prescribe frequently abused drugs 7referred to in this paragraph as a prescriber7 who may write prescriptions for such drugs for such beneficiary2 and 7,,ii7 one1 or1 if the ,,pdp sponsor reasonably determines it necessary to provide the beneficiary with reasonable access under clause 7ii71 more than one1 pharmacy that may dispense such drugs to such beneficiary4 7ii7 ,reasonable access ,in making the selection under this subparagraph1 a ,,pdp sponsor shall ensure1 taking into account geographic location1 beneficiary preference1 impact on cost-sharing1 and reasonable travel time1 that the beneficiary continues to have reasonable access to drugs described in subparagraph 7,g71 including-- 7,i7 for individuals with multiple residences2 and 7,,ii7 in the case of natural disasters and similar emergency situations4 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 beneficiary4 ,if the ,,pdp sponsor changes the selection pursuant to the preceding sentence1 the ,,pdp sponsor shall provide the beneficiary with-- 7aa7 at least #cj days written notice of the change of selection2 and 7bb7 a rationale for the change4 7,,iii7 ,timing ,an at-risk beneficiary for prescription drug abuse may choose to express their prescriber and pharmacy preference at any date while enrolled in the program1 including after a second notice under subparagraph 7,b77iii7 has been provided4 7iv7 ,confirmation ,before selecting a prescriber or pharmacy under this subparagraph1 a ,,pdp sponsor must notify the prescriber and pharmacy that the beneficiary involved has been identified for inclusion in the drug management program for at-risk beneficiaries and that the prescriber and pharmacy has been selected as the beneficiary's designated prescriber and pharmacy4 7,e7 ,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 an expedited reconsideration and appeal pursuant to subsection 7h74 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 determined by the ,secretary to be frequently abused or diverted and that is-- 7i7 a ,controlled ,drug ,substance in ,schedule ,,cii2 or 7ii7 within the same class or category of drugs as a ,controlled ,drug ,substance in ,schedule ,,cii1 as determined through notice and comment rulemaking4 7,h7 ,data disclosure 7i7 ,data on decision to impose limitation ,in the case of an at-risk beneficiary for prescription drug abuse 7or an individual who is a potentially at-risk beneficiary for prescription drug abuse7 whose access to coverage for frequently abused drugs under a prescription drug plan has been limited by a ,,pdp sponsor under this paragraph1 the ,secretary shall establish rules and procedures to require such ,,pdp sponsor to disclose data1 including necessary individually identifiable health information1 about the decision to impose such limitations and the limitations imposed by the ,,pdp sponsor under this part4 7ii7 ,data to reduce fraud1 abuse1 and waste ,the ,secretary shall establish rules and procedures to require ,,pdp sponsors operating a drug management program for at-risk beneficiaries under this paragraph to provide the ,secretary with such data as the ,secretary determines appropriate for purposes of identifying patterns of prescription drug utilization for plan enrollees that are outside normal patterns and that may indicate fraudulent1 medically unnecessary1 or unsafe use4 7,i7 ,sharing of information for subsequent plan enrollments ,the ,secretary shall establish procedures under which ,,pdp sponsors who offer prescription drug plans shall share information with respect to individuals who are at-risk beneficiaries for prescription drug abuse 7or individuals who are potentially at-risk beneficiaries for prescription drug abuse7 and enrolled in a prescription drug plan and who subsequently disenroll from such plan and enroll in another prescription drug plan offered by another ,,pdp sponsor4 7,j7 ,privacy issues ,prior to the implementation of the rules and procedures under this paragraph1 the ,secretary shall clarify privacy requirements1 including requirements under the regulations promulgated pursuant to section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7#db ,u4,s4,c4 #acbj;d-#b note71 related to the sharing of data under subparagraphs 7,h7 and 7,i7 by ,,pdp sponsors4 ,such clarification shall provide that the sharing of such data shall be considered to be protected health information in accordance with the requirements of the regulations promulgated pursuant to such section #bfd7;c74 7,k7 ,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 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,l7 ,,cms compliance review ,the ,secretary shall ensure that existing plan sponsor compliance reviews and audit processes include the drug management programs for at-risk beneficiaries under this paragraph1 including appeals processes under such programs4 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 7#c7 ,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#e7 after the ,secretary4 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 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#e77;,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 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 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 7,c7 ,,cms compliance review ,the ,secretary shall ensure that plan sponsor annual compliance reviews and program audits include a certification that utilization management tools under this paragraph are in compliance with the requirements for such tools4 4 7c7 ,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 7d7 ,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 7e7 ,,gao study and report 7#a7 ,study ,the ,comptroller ,general of the ,united ,states shall conduct a study on the implementation of the amendments made by this section1 including the effectiveness of the at-risk beneficiaries for prescription drug abuse drug management programs authorized by section #ahfj;,d-#d7;c77#e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aj7;c77#e771 as added by subsection 7a77#a74 ,such study shall include an analysis of-- 7,a7 the impediments1 if any1 that impair the ability of individuals described in subparagraph 7,c7 of such section #ahfj;,d-#d7;c77#e7 to access clinically appropriate levels of prescription drugs2 7,b7 the types of-- 7i7 individuals who1 in the implementation of such section1 are determined to be individuals described in such subparagraph2 and 7ii7 prescribers and pharmacies that are selected under subparagraph 7,d7 of such section2 7,c7 the extent of prescription drug abuse beyond ,controlled ,drug ,substances in ,schedule ,,cii in parts ,c and ,d of the ,medicare program2 and 7,d7 other areas determined appropriate by the ,comptroller ,general4 7#b7 ,report ,not later than ,july #a1 #bjai1 the ,comptroller ,general of the ,united ,states shall submit to the appropriate committees of jurisdiction of ,congress a report on the study conducted under paragraph 7#a71 together with recommendations for such legislation and administrative action as the ,comptroller ,general determines to be appropriate4 7f7 ,report by ,secretary 7#a7 ,in general ,not later than #ab months after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall submit to the appropriate committees of jurisdiction of ,congress a report on ways to improve upon the appeals process for ,medicare beneficiaries with respect to prescription drug coverage under part ,d of title ,,xviii of the ,social ,security ,act4 ,such report shall include an analysis comparing appeals processes under parts ,c and ,d of such title ,,xviii4 7#b7 ,feedback ,in development of the report described in paragraph 7#a71 the ,secretary of ,health and ,human ,services shall solicit feedback on the current appeals process from stakeholders1 such as beneficiaries1 consumer advocates1 plan sponsors1 pharmacy benefit managers1 pharmacists1 providers1 independent review entity evaluators1 and pharmaceutical manufacturers4 7g7 ,effective date 7#a7 ,in general ,except as provided in subsection 7d77#b71 the amendments made by this section shall apply to prescription drug plans for plan years beginning on or after ,january #a1 #bjah4 7#b7 ,stakeholder meetings prior to effective date 7,a7 ,in general ,not later than ,january #a1 #bjag1 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 pharmacists1 retail pharmacies1 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 sponsors who are at-risk beneficiaries for prescription drug abuse 7as defined in paragraph 7#e77;,c7 of section #ahfj;,d-#d7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aj7;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 ,act72 7iii7 the types of enrollees that should be treated as exempted individuals1 as described in clause 7ii7 of such paragraph2 7iv7 the manner in which terms and definitions in paragraph 7#e7 of such section #ahfj;,d-#d7;c7 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 paragraph 7#e72 7v7 the information to be included in the notices described in subparagraph 7,b7 of such section and the standardization of such notices2 7vi7 with respect to a ,,pdp sponsor that establishes a drug management program for at-risk beneficiaries under such paragraph 7#e71 the responsibilities of such ,,pdp sponsor with respect to the implementation of such program2 7vii7 notices for plan enrollees at the point of sale that would explain why an at-risk beneficiary has been prohibited from receiving a prescription at a location outside of the designated pharmacy2 and 7viii7 evidence-based prescribing guidelines for opiates4 7,c7 ,rulemaking ,the ,secretary of ,health and ,human ,services shall1 taking into account the input gathered pursuant to subparagraph 7,a7 and after providing notice and an opportunity to comment1 promulgate regulations to carry out the provisions of1 and amendments made by subsections 7a7 and 7b74