,i #aadth ,,congress #ast ,session ,h4 ,r4 #dbib ,,in ,,the ,,house ,,of ,,representatives ,december #ah1 #bjae ,mrs4 ,noem 7for herself and ,mr4 ,pascrell7 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 provide for research and the testing of innovative health care delivery models to improve medication adherence1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,synchronization ,nonadherence ,correction 7,,sync7 ,act of #bjae4 #b4 ,findings ,congress makes the following findings3 7#a7 ,between one-half and two-thirds of patients with chronic diseases in the ,united ,states do not take medications as prescribed4 7#b7 ,low rates of medication adherence result in higher health care costs1 reduced effectiveness of health care treatments and regimens1 negative health effects for patients1 and tens of thousands of deaths on an annual basis4 7#c7 ,medication adherence may be lowest among patients with chronic diseases4 7#d7 ,improving medication adherence would reduce unnecessary hospital admissions and emergency room visits4 7#e7 ,nonadherence is estimated to cost the ,united ,states health care system over #ajj1jjj1jjj1jjj each year4 7#f7 ,improving medication adherence could improve patient health outcomes1 reduce health care costs1 and lead to productivity gains4 #c4 ,definitions ,in this ,act3 7#a7 ,the term applicable individual means an applicable individual 7as defined in section #aaae;,a7a77#d77;,a7 of the ,social ,security ,act1 #db ,u4,s4,c4 #acae7;a77#d77;,a77 who has been prescribed #b or more chronic care medications4 7#b7 ,the term medication adherence means a patient taking medications according to the prescribed dosage1 time1 frequency1 and direction4 7#c7 ,the term medication wastage means1 with respect to a medication1 a switch of the medication or strength of the medication within the same therapeutic class that occurs before the expected refill date4 7#d7 ,the term persistence means the act of continuing treatment with a medication for the prescribed duration4 7#e7 ,the term primary nonadherence means the failure to pickup a newly prescribed medication from a pharmacy4 7#f7 ,the term ,secretary means the ,secretary of ,health and ,human ,services4 7#g7 ,the term synchronization means the coordination of medication refills for a patient taking two or more chronic medications such that the patient's medications are refilled on the same schedule for a given time period4 #d4 ,national research and reporting strategy for improved medication adherence 7a7 ,in general ,the ,secretary of ,health and ,human ,services1 acting through the ,agency for ,healthcare ,research and ,quality1 the ,centers for ,medicare ,medicaid ,services1 the ,health ,resources and ,services ,administration1 the ,director of the ,national ,institutes of ,health1 and the ,director of the ,centers for ,disease ,control and ,prevention1 and in coordination with the ,patient-,centered ,outcomes ,research ,institute1 shall conduct research and develop information to better inform decisionmakers regarding medication adherence and medication persistence1 and methods to improve medication adherence and persistence in ,federal health programs4 7b7 ,activities included ,the activities described in subsection 7a7 shall include development of annual statistics on recommended medications1 the rate of medication adherence1 the rate of primary nonadherence1 and the rate of medication persistence for patients with chronic diseases such as cardiovascular disease1 hypertension1 diabetes1 autoimmune diseases1 chronic obstructive pulmonary disease 7,,copd71 and mental health conditions treated under the following health care programs3 7#a7 ,medicare ,the ,medicare program under title ,,xviii of the ,social ,security ,act4 7#b7 ,medicaid ,the ,medicaid program under title ,,xix of such ,act4 7#c7 ,,fehbp ,the ,federal ,employees ,health ,benefit ,program under chapter #hi of title #e1 ,united ,states ,code4 7c7 ,biennial report on medication adherence and medication persistence ,not later than #b years after the date of enactment of this ,act 7and annually thereafter71 the ,secretary shall submit to ,congress a report on the statistics collected under subsection 7a71 together with recommendations for such legislation and administrative action to address problems and improve medication adherence and medication persistence as the ,secretary determines appropriate4 #e4 ,testing models for improving medication adherence 7a7 ,in general ,the ,secretary shall test innovative health care delivery models1 as described in subsections 7b7 and 7c71 to improve medication adherence and medication persistence1 with the goal of improving health outcomes and decreasing health costs for chronic care conditions4 7b7 ,models ,to test efficacy of synchronization 7#a7 ,in general ,the model described in this subsection shall test the efficacy of synchronization of prescription drug medications for applicable enrollees in improving medication adherence1 determining cost avoidance1 and improving outcomes for those enrollees4 7#b7 ,participation ,an applicable enrollee who is eligible to participate in the model testing under this subsection shall participate in the model testing1 unless the enrollee elects not to participate in the model4 7#c7 ,models tested ,the following models of synchronization shall be tested under this subsection3 7,a7 ,model #a ,synchronization 7synchronization of prescription drug medications and medication reconciliation phone calls or electronic communication with enrollees prior to filling prescriptions74 7,b7 ,model #b ,synchronization 7as described in subparagraph 7,a77 and compliance-based packaging4 7,c7 ,model #c ,synchronization 7as described in subparagraph 7,a77 and ongoing pharmacist counseling that shall occur at the patient's request and include review of the appropriateness of the medication regimen and any barriers to medication adherence4 7#d7 ,evaluation ,the ,secretary shall evaluate the models in paragraph 7#c7 by collecting and analyzing relevant plan and enrollee data1 including at least the following3 7,a7 ,synchronization enrollment and drop-out rates4 7,b7 ,primary medication nonadherence4 7,c7 ,medication adherence and persistence rates4 7,d7 ,demographic characteristics of applicable enrollees4 7,e7 ,plan characteristics1 such as plan benefit design4 7,f7 ,impact of the models on applicable enrollees who are-- 7i7 eligible for benefits under a ,state plan under title ,,xix of the ,social ,security2 or 7ii7 eligible for premium and cost-sharing subsidies under section #ahfj;,d-#ad7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a774 7,g7 ,prescription drug claims data in comparison to other medical claims data for applicable enrollees in order to examine the effect of synchronization and adherence on overall health spending1 including health care costs avoided1 and patient outcomes4 7c7 ,testing #ij-;,day fills at retail pharmacies for the first prescription 7#a7 ,in general ,the ,secretary shall conduct a demonstration that compares the use of #ij-;day first fills of prescriptions at retail pharmacies or using mail-order for maintenance medications against #cj-;day first fills for applicable enrollees under part ,d of title ,,xviii of the ,social ,security ,act1 to determine whether there is an impact on medication persistence1 cost avoidance1 and improving outcomes for those enrollees in subsequent refill periods4 7#b7 ,drugs ,tested ,the model under this subsection shall only pertain to first fills for maintenance drugs treating chronic diseases such as cardiovascular disease1 hypertension1 diabetes1 autoimmune diseases1 chronic obstructive pulmonary disease 7,,copd71 and mental health conditions4 7#c7 ,evaluation of demonstration by ,,gao 7,a7 ,provision of data for evaluation ,the ,secretary shall make available to the ,comptroller ,general of the ,united ,states relevant plan and enrollee data in order to enable an evaluation of the demonstration under this subsection under subparagraph 7,b74 7,b7 ,evaluation ,using data made available under subparagraph 7,a7 and other relevant data1 the ,comptroller ,general of the ,united ,states shall evaluate the demonstration conducted under this subsection4 ,such evaluation shall examine the effect of long-term fills and adherence on overall health spending1 including health care costs avoided1 and patient outcome1 and shall examine at least the following in relation to part ,d enrollees using #ij-;day first fills in comparison with those enrollees using #cj-;day first fills3 7i7 ,medication adherence and persistence rates4 7ii7 ,cost differentials in pharmacy costs4 7iii7 ,prescription drug claims data in comparison to other medical claims4 7iv7 ,medication wastage 7as defined in section #c74 7,c7 ,report ,the ,comptroller ,general shall submit a report to the ,secretary and ,congress on the evaluation conducted under this paragraph4