,,ib ,union ,calendar ,no4 #efa #aaeth ,,congress #b;d ,session ,h4 ,r4 #ehjh ,report ,no4 #aae-gbf ,,in ,,the ,,house ,,of ,,representatives ,may #ae1 #bjah ,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 ,commerce ,june #ab1 #bjah;,additional sponsors3 ,mrs4 ,blackburn and ,mr4 ,walden ,june #ab1 #bjah ,committed to the ,committee of the ,whole ,house on the ,state of the ,union and ordered to be printed ,a ,,bill ,to amend title ,,xix of the ,social ,security ,act to require ,states to operate drug management programs for at-risk beneficiaries1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,medicaid ,pharmaceutical ,home ,act of #bjah4 #b4 ,drug management program for at-risk beneficiaries 7a7 ,in general ,title ,,xix of the ,social ,security ,act is amended by inserting after section #aibg 7#db ,u4,s4,c4 #acifr-#h7 the following new section3 #aibg;,a4 ,drug management program for at-risk beneficiaries 7a7 ,in general ,beginning ,january #a1 #bjbj1 a ,state shall operate a qualified drug management program under which a ,state may enroll certain at-risk beneficiaries identified by the ,state under the program4 7b7 ,qualified drug management program ,for purposes of this section1 the term qualified drug management program means1 with respect to a ,state1 a program carried out by the ,state 7including through a contract with a pharmacy benefit manager7 that provides at least for the following3 7#a7 ,identification of at-risk individuals ,under the program1 the ,state identifies1 in accordance with subsection 7c71 individuals enrolled under the ,state plan 7or waiver of the ,state plan7 who are at-risk beneficiaries4 7#b7 ,elements of program 7,a7 ,in general ,under the program1 the ,state1 with respect to each individual identified under paragraph 7#a7 and enrolled under the program under paragraph 7#e7-- 7i7 subject to subparagraphs 7,b7 and 7,c71 selects at least one1 but not more than three1 health care providers and at least one1 but not more than three1 pharmacies for each such individual for purposes of clause 7ii71 in accordance with a selection process that takes into account reasonable factors such as the individual's previous utilization of items and services from health care providers and pharmacies1 geographic proximity of the individual to such health care providers and pharmacies1 access of the individual to health care1 reasonable travel time1 information regarding housing status1 and any known preference of the individual for a certain health care provider or pharmacy2 and 7ii7 requires that any controlled substance furnished to such individual during the period for which such individual is enrolled under the program be prescribed by a health care provider selected under clause 7i7 for such individual and dispensed by a pharmacy selected under clause 7i7 for such individual in order for such controlled substance to be covered under the ,state plan 7or waiver74 7,b7 ,beneficiary preference ,in the case of an individual receiving a notice under paragraph 7#c77;,a7 of being identified as potentially being an at-risk beneficiary described in such paragraph1 such individual may submit1 during the #cj-;day period following receipt of such notice1 preferences for which health care providers and pharmacies the individual would prefer the ,state to select under subparagraph 7,a74 ,the ,state shall select or change the selection of health care providers and pharmacies under subparagraph 7,a7 for the individuals based on such preferences1 except that in the case that ,state determines that such selection 7or change of selection7 of a health care provider or pharmacy under subparagraph 7,a7 is contributing or would contribute to prescription drug abuse or drug diversion by the individual1 the ,state may select or change the selection of health care provider or pharmacy for the individual without regard to the preferences of the individual described in this subparagraph4 ,if the ,state selects or changes the selection pursuant to the preceding sentence without regard to the preferences of the individual1 the ,state shall provide the individual with at least #cj days written notice of the selection or change of selection and a rationale for the selection or change4 7,c7 ,treatment of pharmacy with multiple locations ,for purposes of subparagraph 7,a77i71 in the case of a pharmacy that has multiple locations that share real-time electronic prescription data and the same chain identification number1 all such locations of the pharmacy shall collectively be treated as one pharmacy4 7,d7 ,treatment of existing ,,ffs drug management programs ,in the case of a patient review and restriction program 7as identified in the annual report submitted to the ,secretary under section #aibg7;g77#c77;,d77 operated by a ,state pursuant to section #aiae7;a77#b7 before the date of the enactment of this section1 such program shall be treated as a qualified drug management program4 7,e7 ,reasonable access ,the program shall ensure1 including through waiver of elements of the program 7including under subparagraph 7,a77ii771 reasonable access to health care 7including access to health care providers and pharmacies with respect to prescription drugs described in subparagraph 7,a77 in the case of individuals with multiple residences1 in the case of natural disasters and similar situations1 and in the case of the provision of emergency services 7as defined for purposes of section #ahfj;,d-#d7;c77#e77;,d77ii77,,ii774 7#c7 ,notification to identified individuals ,under the program1 the ,state provides each individual who is identified under paragraph 7#a71 prior to enrolling such individual under the program1 at least one notification of each of the following3 7,a7 ,notice that the ,state has identified the individual as potentially being an at-risk beneficiary for abuse or misuse of a controlled substance4 7,b7 ,the name1 address1 and contact information of each health care provider and pharmacy that may be selected for the individual under paragraph 7#b77;,a74 7,c7 ,information describing all ,state and ,federal public health resources that are designed to address such abuse or misuse to which the individual has access1 including mental health services and other counseling services4 7,d7 ,notice of1 and information about1 the right of the individual to-- 7i7 submit preferences of the individual for health care providers and pharmacies to be selected under paragraph 7#b77;,a71 including as described in paragraph 7#b77;,b72 7ii7 appeal under paragraph 7#d7-- 7,i7 such identification described in subparagraph 7,a72 and 7,,ii7 the selection of health care providers and pharmacies under paragraph 7#b77;,a74 7,e7 ,an explanation of the meaning and consequences of the identification of the individual as potentially being an at-risk beneficiary for abuse or misuse of a controlled substance1 including an explanation of the program4 7,f7 ,information1 including a contact list and clear instructions1 that explain how the individual can contact the appropriate entities administering the program in order to submit preferences described in paragraph 7#b77;,b7 and any other communications relating to the program4 7#d7 ,appeals process ,under the program1 the ,state provides for an appeals process under which1 with respect to an individual identified under paragraph 7#a7-- 7,a7 such individual may appeal-- 7i7 such identification2 and 7ii7 the selection of a health care provider or pharmacy under paragraph 7#b77;,a72 7,b7 in the case of an appeal described in subparagraph 7,a77ii71 the ,state shall accommodate the health care provider or pharmacy preferred by the individual for selection for purposes of paragraph 7#b77;,a71 unless the ,state determines that a change to the selection of health care provider or pharmacy under such paragraph is contributing or would contribute to prescription drug abuse or drug diversion by the individual2 7,c7 such individual is provided a period of not less than #cj days following the date of receipt of the notice described in paragraph 7#c7 to submit such appeal2 and 7,d7 the ,state must make a determination with respect to an appeal described in subparagraph 7,a71 and notify the individual of such determination1 prior to enrollment of such individual in the program4 7#e7 ,enrollment ,under the program1 the ,state initially enrolls individuals who are identified under paragraph 7#a7 in the program for a #ab-month period-- 7,a7 in the case of such an individual who does not submit an appeal under paragraph 7#d7 within the period applied by the ,state pursuant to subparagraph 7,c7 of such paragraph1 beginning on the day after the last day of such period2 and 7,b7 in the case of such an individual who does submit an appeal under paragraph 7#d7 within the period applied by the ,state pursuant to subparagraph 7,c7 of such paragraph but such appeal is denied1 beginning not later than #cj days after the date of such denial4 7#f7 ,notification of health care providers and pharmacies ,under the program1 the ,state provides to each health care provider and pharmacy selected for an individual under paragraph 7#b7-- 7,a7 notification that the individual is an at-risk beneficiary enrolled under the program and that the provider or pharmacy has been selected for the individual under paragraph 7#b72 7,b7 information on such program and the role of being so selected2 and 7,c7 a process through which the provider or pharmacy can submit a concern or complaint with respect to being so selected and refuse to be a provider or pharmacy so selected4 7#g7 ,continuation of enrollment ,under the program1 the ,state1 with respect to an individual enrolled under the program1 provides for a process to-- 7,a7 not later than #cj days before the end of the #ab-month period for which the individual is so enrolled pursuant to paragraph 7#e7-- 7i7 assess1 in accordance with publicly available evidence-based guidelines1 whether or not such individual should continue to be enrolled under the program2 and 7ii7 notify such individual of the results of the assessment under clause 7i72 7,b7 continue1 subject to subparagraph 7,c71 enrollment of such individual if such assessment recommends such continuation2 and 7,c7 appeal the continuation of enrollment in accordance with the appeals process described in paragraph 7#d74 7c7 ,at-,risk beneficiary 7#a7 ,identification ,for purposes of this section1 a ,state shall identify an individual enrolled under the ,state plan 7or waiver of the ,state plan7 as an at-risk beneficiary if the individual is not an exempted individual described in paragraph 7#b7 and-- 7,a7 is identified as such an at-risk beneficiary through the use of publicly available evidence-based guidelines that indicate misuse or abuse of a controlled substance2 or 7,b7 the ,state received notification from a ,,pdp sponsor or ,medicare ,advantage organization that such individual was identified as being an at-risk beneficiary for prescription drug abuse for enrollment in a drug management program established by the sponsor or organization pursuant to section #ahfj;,d-#d7;c77#e7 and such identification has not been terminated under subparagraph 7,f7 of such section4 7#b7 ,exempted individual described ,for purposes of paragraph 7#a71 an exempted individual described in this paragraph is an individual who-- 7,a7 is receiving-- 7i7 hospice or palliative care2 or 7ii7 treatment for cancer2 7,b7 is a resident of a long-term care facility1 of a facility described in section #aije7;d71 or of another facility for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy2 or 7,c7 the ,state elects to treat as an exempted individual for purposes of paragraph 7#a74 7d7 ,application of privacy rules clarification ,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 subsection 7b77#f7 in the same manner as the ,secretary is required under subparagraph 7,j7 of section #ahfj;,d-#d7;c77#e7 to clarify privacy requirements related to the sharing of data described in such subparagraph4 7e7 ,reports 7#a7 ,annual reports ,a ,state operating a qualified drug management program shall include in the annual report submitted to the ,secretary under section #aibg7;g77#c77;,d71 beginning with such reports submitted for #bjba1 the following information3 7,a7 ,the number of individuals enrolled under the ,state plan 7or waiver of the ,state plan7 who are enrolled under the program and the percentage of individuals enrolled under the ,state plan 7or waiver7 who are enrolled under such program4 7,b7 ,the number of prescriptions for controlled substances that were dispensed per month during each such year per individual enrolled under the program1 including the dosage and pill count for each such prescription4 7,c7 ,the number of pharmacies filling prescriptions for controlled substances for individuals enrolled under such program4 7,d7 ,the number of health care providers writing prescriptions for controlled substances 7other than prescriptions for a refill7 for individuals enrolled under such program4 7,e7 ,any other data that the ,secretary may require4 7,f7 ,any report submitted by a managed care entity under subsection 7e77#b7 with respect to years4 ,for each such report for a year after #bjba1 the information described in this paragraph shall be provided in a manner that compares such information with respect to the prior calendar year to such information with respect to the second prior calendar year4 7#b7 ,,macpac reports and review ,not later than two years after the date of the enactment of this section1 the ,medicaid and ,,chip ,payment and ,access ,commission 7in this section referred to as ,,macpac71 in consultation with the ,national ,association of ,medicaid ,directors1 pharmacy benefit managers1 managed care organizations1 health care providers 7including pharmacists71 beneficiary advocates1 and other stakeholders1 shall publish a report that includes-- 7,a7 best practices for operating drug management programs1 based on a review of a representative sample of ,states administering such a program2 7,b7 a summary of the experience of the appeals process under drug management programs operated by several ,states1 such as the frequency at which individuals appealed the identification of being an at-risk individual1 the frequency at which individuals appealed the selection of a health care provider or pharmacy under such a program1 the timeframes for such appeals1 a summary of the reasons for such appeals1 and the design of such appeals processes2 7,c7 a summary of trends and the effectiveness of qualified drug management programs operated under this section2 and 7,d7 recommendations to ,states on how improvements can be made with respect to the operation of such programs4 ,in reporting on ,state practices1 the ,,macpac shall consider how such programs have been implemented in rural areas1 under fee-for-service as well as managed care arrangements1 and the extent to which such programs have resulted in increased efficiencies to such ,states or to the ,federal ,government under this title4 7#c7 ,report on plan for coordinated care ,not later than ,january #a1 #bjba1 each ,state operating a qualified drug management program shall submit to the ,administrator of the ,centers for ,medicare ,medicaid ,services a report on how such ,state plans to provide coordinated care for individuals enrolled under the ,state plan 7or waiver of the ,state plan7 and-- 7,a7 who are enrolled under the program2 or 7,b7 who are enrolled with a managed care entity and enrolled under such a qualified drug management program operated by such entity4 7f7 ,applicability to managed care entities 7#a7 ,in general ,with respect to any contract that a ,state enters into on or after ,january #a1 #bjbj1 with a managed care entity 7as defined in section #aicb7;a77#a77;,b77 pursuant to section #aijc7m71 the ,state shall1 as a condition of the contract1 require the managed care entity-- 7,a7 to operate a qualified drug management program 7as defined in subsection 7b77 for at-risk beneficiaries who are enrolled with such entity and identified by the managed care entity by means of application of paragraph 7#b72 7,b7 to submit to the ,state an annual report on the matters described in subparagraphs 7,a7 through 7,e7 of subsection 7e77#a72 and 7,c7 to submit to the ,state a list 7and as necessary update such list7 of individuals enrolled with such entity under the qualified drug management program operated by such entity under subparagraph 7,a7 for purposes of allowing ,state plans for which medical assistance is paid on a fee-for-service basis to have access to such information4 7#b7 ,application ,for purposes of applying1 with respect to a managed care entity-- 7,a7 under paragraph 7#a77;,a7-- 7i7 the definition of the term qualified drug management program under subsection 7b71 other than paragraph 7#b77;,d7 of such subsection2 and 7ii7 the provisions of paragraphs 7#a7 and 7#b7 of subsection 7c72 and 7,b7 under paragraph 7#a77;,b71 the report requirements described in subparagraphs 7,a7 through 7,e7 of subsection 7e77#a72 each reference in such subsection 7b7 and paragraphs of subsection 7c7 to a ,state or the ,state 7other than to a ,state plan or the ,state plan7 shall be deemed a reference to the managed care entity1 each reference under such subsection1 paragraphs1 or subparagraphs to individuals enrolled under the ,state plan 7or waiver of the ,state plan7 shall be deemed a reference to individuals enrolled with such entity1 and each reference under such subsection1 paragraphs1 or subparagraphs to individuals enrolled under the qualified drug management program operated by the ,state shall be deemed a reference to individuals enrolled under the qualified drug management program operated by the managed care entity4 7g7 ,controlled substance defined ,for purposes of this section1 the term controlled substance means a drug that is included in schedule ,,ii1 ,,iii1 or ,,iv of section #bjb7;c7 of the ,controlled ,substances ,act1 or any combination thereof1 as specified by the ,state4 4 7b7 ,guidance on at-,risk population transitioning between ,medicaid ,,ffs and managed care ,not later than ,october #a1 #bjai1 the ,secretary of ,health and ,human ,services shall issue guidance for ,state ,medicaid programs1 with respect to individuals who are enrolled under a ,state plan 7or waiver of such plan7 under title ,,xix of the ,social ,security ,act and under a drug management program1 for purposes of providing best practices-- 7#a7 for transitioning1 as applicable1 such individuals from fee-for-service ,medicaid 7and such a program operated by the ,state7 to receiving medical assistance under such title through a managed care entity 7as defined in section #aicb7;a77#a77;,b7 of the ,social ,security ,act7 with a contract that with the ,state pursuant to section #aijc7m7 of such ,act 7and such a program operated by such entity72 and 7#b7 for transitioning1 as applicable1 such individuals from receiving medical assistance under such title through a managed care entity 7as defined in section #aicb7;a77#a77;,b7 of the ,social ,security ,act7 with a contract that with the ,state pursuant to section #aijc7m7 of such ,act 7and such a program operated by such entity7 to fee-for-service ,medicaid 7and such a program operated by the ,state74 7c7 ,guidance on at-,risk population transitioning to ,medicare 7#a7 ,in general ,not later than ,january #a1 #bjbj1 the ,secretary of ,health and ,human ,services1 after consultation with the ,federal ,coordinated ,health ,care ,office established under section #bfjb of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #acae;b71 shall issue guidance for ,state ,medicaid programs1 with respect to transitioning individuals1 providing for-- 7,a7 notification to be submitted by the ,state to the ,centers for ,medicare ,medicaid ,services and such individuals of the status of such individuals as transitioning individuals2 7,b7 notification to such individuals about enrollment under a prescription drug plan under part ,d of such title or under a ,,ma-,,pd plan under part ,c of such title2 7,c7 best practices for transitioning such individuals to such a plan2 and 7,d7 best practices for coordination between the qualified drug management program 7as described in section #aibg;,a7b7 of the ,social ,security ,act1 as added by subsection 7a77 carried out by the ,state and a drug management program carried out under such a plan pursuant to section #ahfj;,d-#d7;c77#e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aj7;c77#e774 7#b7 ,transitioning individuals ,for purposes of paragraph 7#a71 a transitioning individual is an individual who1 with respect to a month-- 7,a7 is enrolled under the ,state plan 7or waiver of the ,state plan7 and under the qualified drug management program 7as described in section #aibg;,a7b7 of the ,social ,security ,act1 as added by subsection 7a77 carried out by the ,state2 and 7,b7 is expected to become eligible for the ,medicare program under title ,,xviii of such ,act during the subsequent #ab-month period4 ,june #ab1 #bjah ,committed to the ,committee of the ,whole ,house on the ,state of the ,union and ordered to be printed