title: Changes in drug utilization following the outpatient prescription drug cost-sharing program--evidence from Taiwan's elderly. Adverse events associated with prescription drug cost-sharing among poor and elderly persons. Clinical and economic consequences of a reimbursement restriction of nebulised respiratory therapy in adults: direct comparison of randomised and observational evaluations Rationale and design of the Post-MI FREEE trial: a randomized evaluation of first-dollar drug coverage for post-myocardial infarction secondary preventive therapies. Impact of final short-fill rule on Medicare Part D costs and long-term care pharmacy dispensing. The Impact of Medicare Part D on Medicare-Medicaid Dual-Eligible Beneficiaries' Prescription Utilization and Expenditures Effect of Increased Copayments on Pharmacy Use in the Department of Veterans Affairs Assessing the Effect of Taiwan’s Outpatient Prescription Drug Copayment Policy in the Elderly Prescription drug costs for dually eligible people in a medicaid home- and community-based services program. The demand for prescription drugs as a function of cost-sharing. The effect of cost sharing on the use of antibiotics in ambulatory care: results from a population-based randomized controlled trial. The impact of cost sharing on emergency department use. Analysis of national annual variation in total patient out-of-pocket Medicare Part D stand-alone prescription drug plan costs from 2007 to 2008 The effects of expanded mental health benefits on treatment costs. The Effect of the Medicare Part D Prescription Benefit on Drug Utilization and Expenditures Effect of the Medicare Part D Coverage Gap on Medication Use Among Patients With Hypertension and Hyperlipidemia
abstract: This paper examines changes in drug utilization following Taiwan 's newly implemented National Health Insurance ( NHI ) outpatient prescription drug cost-sharing program for persons over 65 years old . The study is a hospital outpatient prescription level analysis that adopts a pretest-posttest control group experiment design . Selected measures of outpatient prescription drug utilization are examined for cost-sharing and non cost-sharing groups in cost-sharing periods and pre cost-sharing periods . Additional analyses were conducted comparing older patients with and without chronic diseases and differences for essential and non-essential drugs . Patients over age 65 were drawn from 21 hospitals in the Taipei area using a stratified r and om sampling method . This paper yields several interesting findings . First , average prescription cost and prescription period increased for both the cost-sharing and non cost-sharing groups . However , the rate of increase was significantly less in the cost-sharing group when compared with the non cost-sharing group . Second , the elderly with non-chronic diseases were more sensitive ( i.e. , reducing drug utilization ) to the drug cost-sharing program when compared with those with chronic diseases . Third , for the elderly with non-chronic diseases average drug cost per prescription experienced a smaller decrease in essential drugs but a moderate increase in non-essential drugs for the cost-sharing group . By contrast , for the non cost-sharing group , average drug cost per prescription increased sharply in non-essential drugs as well as essential drugs . Finally , there was a significant increase in the number of prescriptions as well as drug costs above the upper bound of the cost-sharing schedule . The  outpatient drug cost-sharing program  implemented by the NHI in Taiwan did not reverse the trend of prescription drug cost increases in hospitals . The significant increase in the number of prescriptions above the upper bound of the cost-sharing schedule implies that the NHI should increase the upper bound . Further analysis needs to evaluate any adverse clinical impact for older patients result ing from policy changes CONTEXT Rising costs of medications and inequities in access have sparked calls for drug policy reform in the United States and Canada . Control of drug expenditures by prescription cost-sharing for elderly persons and poor persons is a contentious issue because little is known about the health impact in these subgroups . OBJECTIVES To determine ( 1 ) the impact of introducing prescription drug cost-sharing on use of essential and less essential drugs among elderly persons and welfare recipients and ( 2 ) rates of emergency department ( ED ) visits and serious adverse events associated with reductions in drug use before and after policy implementation . DESIGN AND SETTING Interrupted time-series analysis of data from 32 months before and 17 months after introduction of a prescription coinsurance and deductible cost-sharing policy in Quebec in 1996 . Separate 10-month prepolicy control and postpolicy cohort studies were conducted to estimate the impact of the drug reform on adverse events . PARTICIPANTS A r and om sample of 93 950 elderly persons and 55 333 adult welfare medication recipients . MAIN OUTCOME MEASURES Mean daily number of essential and less essential drugs used per month , ED visits , and serious adverse events ( hospitalization , nursing home admission , and mortality ) before and after policy introduction . RESULTS After cost-sharing was introduced , use of essential drugs decreased by 9.12 % ( 95 % confidence interval [ CI ] , 8.7%-9.6 % ) in elderly persons and by 14.42 % ( 95 % CI , 13.3%-15.6 % ) in welfare recipients ; use of less essential drugs decreased by 15.14 % ( 95 % CI , 14.4%-15.9 % ) and 22.39 % ( 95 % CI , 20.9%-23.9 % ) , respectively . The rate ( per 10 000 person-months ) of serious adverse events associated with reductions in use of essential drugs increased from 5.8 in the prepolicy control cohort to 12.6 in the postpolicy cohort in elderly persons ( a net increase of 6.8 [ 95 % CI , 5.6 - 8.0 ] ) and from 14.7 to 27.6 in welfare recipients ( a net increase of 12.9 [ 95 % CI , 10.2 - 15.5 ] ) . Emergency department visit rates related to reductions in the use of essential drugs also increased by 14.2 ( 95 % CI , 8.5 - 19.9 ) per 10 000 person-months in elderly persons ( prepolicy control cohort , 32.9 ; postpolicy cohort , 47.1 ) and by 54.2 ( 95 % CI , 33.5 - 74.8 ) among welfare recipients ( prepolicy control cohort , 69.6 ; postpolicy cohort , 123.8 ) . These increases were primarily due to an increase in the proportion of recipients who reduced their use of essential drugs . Reductions in the use of less essential drugs were not associated with an increase in risk of adverse events or ED visits . CONCLUSIONS In our study , increased cost-sharing for prescription drugs in elderly persons and welfare recipients was followed by reductions in use of essential drugs and a higher rate of serious adverse events and ED visits associated with these reductions Abstract Objective To compare the results of a r and omised and an observational evaluation of the same policy that restricted reimbursement for nebulised respiratory medications in adult patients in a community setting . Design s Cluster r and omised controlled trial and observational time series with historical controls . Setting Pharmacare , the government funded drug benefits plan for elderly people and patients receiving social assistance in British Columbia , Canada . Participants In the r and omised controlled trial 104 clusters of medical practice s , pair matched by geography and approximately by practice size , were r and omised to the intervention group ( 449 patients affected by the policy on 1 March 1999 ) , and the control group ( offered a six month exemption , affecting 386 patients ) . The observational analysis included all Pharmacare beneficiaries ( excluding the 386 exempt patients ) who had used any nebulised drugs six months before the policy ( 4624 patients ) . Intervention Pharmacare restricted reimbursement for nebulised bronchodilators , steroids , and cromoglycate to patients whose doctors applied for an individual patient 's exemption , giving an appropriate clinical reason . Main outcome measures Number of contacts with doctors and services , emergency admissions to hospital , and utilisation of and expenditure for respiratory drugs in data bases of British Columbia 's Ministry of Health . Results Contacts with doctors or emergency admissions to hospital did not increase in association with the restriction , regardless of the analytical approach . In the observational analysis , we found a reduction of $ C24 per patient month in all nebulised drug use ( 95 % confidence interval 19 to 29 ) and an increase of $ C3 per patient month in all expenditure for inhalers ( 1.4 to 4.5 ) . The r and omised evaluation found savings of $ C8 per patient month for nebulisers ( P = 0.24 ) and no increase in spending on inhalers ( P = 0.79 ) . Correcting for 60 % non-compliance by exempt doctors in a sensitivity analysis yielded similar results as the observational evaluation . Conclusions Observational as well as r and omised analyses found moderate net savings and no increase in unintended healthcare outcomes after restricting reimbursement for nebulised respiratory drugs . R and omised policy trials are feasible and , if carefully implemented , likely to be concordant with observational evaluations BACKGROUND Medication nonadherence is a major public health problem , especially for patients with coronary artery disease . The cost of prescription drugs is a central reason for nonadherence , even for patients with drug insurance . Removing patient out-of-pocket drug costs may increase adherence , improve clinical outcomes , and even reduce overall health costs for high-risk patients . The existing data are inadequate to assess whether this strategy is effective . TRIAL DESIGN The Post-Myocardial Infa rct ion Free Rx and Economic Evaluation ( Post-MI FREEE ) trial aims to evaluate the effect of providing full prescription drug coverage ( ie , no copays , coinsurance , or deductibles ) for statins , beta-blockers , angiotensin-converting enzyme inhibitors , and angiotensin II receptor blockers to patients after being recently discharged from the hospital . Potentially eligible patients will be those individuals who receive their health and pharmacy benefits through Aetna , Inc. Patients enrolled in a Health Savings Account plan , who are > or = 65 years of age , whose plan sponsor ( ie , the employer , union , government , or association that sponsors the particular benefits package ) has opted out of participating in the study , and who do not receive both medical services and pharmacy coverage through Aetna will be excluded . The plan sponsor of each eligible patient will be block r and omized to either full drug coverage or current levels of pharmacy benefit , and all subsequently eligible patients of that same plan sponsor will be assigned to the same benefits group . The primary outcome of the trial is a composite clinical outcome of readmission for acute MI , unstable angina , stroke , congestive heart failure , revascularization , or inhospital cardiovascular death . Secondary outcomes include medication adherence and health care costs . All patients will be followed up for a minimum of 1 year . CONCLUSION The Post-MI FREEE trial will be the first r and omized study to evaluate the impact of reducing cost-sharing for essential cardiac medications in high-risk patients on clinical and economic outcomes OBJECTIVE To evaluate the impact of the final Centers for Medicare & Medicaid Services ' ( CMS ) " short-fill " rule regarding the appropriate dispensing of prescription drugs in long-term care facilities . DESIGN A prospect i ve study to determine rates of unconsumed medication and the net-cost impact on Medicare Part D prescription drug plans based on the proposed and final CMS rule and other scenarios under consideration by CMS . SETTING Four hundred twenty-five long-term care facilities in six states . PATIENTS Residents covered by Medicare Part D. MAIN OUTCOME MEASURES Rates of unconsumed medication , average dispensing fees , potential reduction in unconsumed medication , incremental fills , incremental dispensing fees , net cost or savings to Medicare Part D plans , and percentage increase in fills . RESULTS Total estimates of the cost of unconsumed medication charged to Medicare Part D plans for residents in long-term care facilities are $ 87 million for br and products and $ 39 million for generics annually . Based on current dispensing fees , it is likely that implementation of the final rule will result in incremental costs to CMS plans in the range of $ 30 million annually . The number of Medicare Part D prescription fills will increase by about 20 % . A seven-day fill requirement on br and products would raise incremental costs to more than $ 150 million annually , and inclusion of generic products in a seven-day fill requirement would result in incremental costs in the range of $ 850 million annually . CONCLUSION The final CMS rule on short-fills is unlikely to result in savings to Medicare Part D plans . Shorter fill times and inclusion of generic products would significantly raise costs to these plans OBJECTIVE To examine the effect of Part D on 65 - 78-year-old noninstitutionalized dual eligibles ' prescription utilization and expenditures .  DATA SOURCE R and om sample of unique pharmacy customers of a national retail pharmacy chain who filled at least one prescription during both 2005 and 2006 . For each subject , we obtained cl aims data for every prescription filled between January 1 , 2005 , and April 31 , 2007 . STUDY DESIGN Generalized estimating equations were used to examine the experience of a " treatment " group  ( dual eligibles between 65 and 78 years on January 1 , 2005 ) with that of a " control " group  ( near-elderly patients with Medicaid coverage between 60 and 63 years on January 1 , 2005 ) during the first 18 months after Part D implementation . PRINCIPAL FINDINGS Expenditures for the treatment and control groups tracked each other closely in the pre-Part D period . Immediately following the implementation of Part D , expenditures for both groups decreased and then leveled off . There were no significant changes in trends in the dual eligibles ' out-of-pocket expenditures , total monthly expenditures , pill-days , or total number of prescriptions due to Part D. CONCLUSIONS We find no evidence that Part D adversely affected pharmaceutical utilization or out-of-pocket expenditures of dual eligibles during the transition period , nor during the 16 months subsequent to Part D implementation Objectives : In February 2002 , the Department of Veterans Affairs ( VA ) raised medication copayments from $ 2 to $ 7 per 30-day supply of medication for certain veteran groups . We examined the impact of the copayment increase on medication acquisition from VA . Methods : This was a retrospective cohort study using data from national VA data bases from February 2001 through February 2003 . We took a r and om sample of over 5 % of male VA users in 2001 . Of 149,107 veterans sample d , 19,504 ( 13 % ) had copayments for no drugs , 101,410 ( 68 % ) had copayments for some drugs , and 28,193 ( 19 % ) had  copayments for all drugs . We used multivariable count models to examine changes in the number of 30-day medication supplies after the increase . Results : After the copayment increase , veterans subject to copayments for all drugs received 8 % fewer 30-day supplies of medication annually relative to veterans with no copayments ( P < 0.001 ) . The effect of the copayment increased as the number of different medications veterans received increased . Among veterans subject to copayments for all drugs , acquisition of lower-cost drugs fell by 36 % , higher-cost medications fell by 6 % , over-the-counter medications fell by 40 % , and prescription-only medications fell by 4 % relative to veterans with no drug copayments . Conclusions : The number of medications veterans obtained from VA decreased after the copayment increase . There were relatively larger impacts on veterans with higher medication use and on lower-cost and over-the-counter medications Objectives . This study uses variance cost analysis and regression analysis as tools for investigating the initial effects of Taiwan ’s outpatient prescription drug copayment program in the elderly . Under its new National Health Insurance program , Taiwan implemented a  prescription drug cost-sharing program  August 1 , 1999 . We compare an elderly population ’s prescription drug use after the policy  was implemented with an elderly population ’s prescription drug use before the policy change to describe initial and general consequences of the drug cost-sharing program . Methods . Approximately 240,000 patients aged 65 and over representing 1,600,000 outpatient prescriptions were drawn from 21 hospitals in the Taipei area for the study using a stratified r and om sampling method . Variance analysis , as used primarily in accounting , was applied to decompose overall cost variance of the policy into the sum of variances of several specific factors that are important to policymakers . The cost variances of each specific factor can be further decomposed into sublevels of analyses . Regression analysis is then applied to better underst and covariates that might influence drug cost variances of significant magnitude . Results . The initial effects of the policy change did not reverse the trend of drug cost increases . Instead , there was a significant increase in total prescription drug costs in the cost-sharing group ( approximately 12.86 % ) and an even higher increase rate in the non-cost-sharing group ( approximately 51.42 % ) . The main reason for the drug cost increase for the cost-sharing group was attributed to an increase in average drug costs per prescription ( explaining 69.20 % of the variance ) . We found physicians seemed to prescribe more expensive drugs and extend prescription duration , especially when drug costs exceed the upper bound of the cost-sharing schedule . By contrast , the main factor contributing to the increase in drug costs for the non-cost-sharing group was an increase in average prescription duration ( explaining 64.98 % of the variance ) . The increase mainly results from the effect of extended prescriptions for chronic diseases that were design ed to reduce unnecessary visits for refills . Discussion . The significant increase in average drug price per prescription indicates that many prescriptions could move above the upper bound of the cost-sharing schedule . The results suggest that the Bureau of National Health Insurance should increase the upper bound . We do not think these effects are unique to Taiwan . Rather , these effects should be considered as countries change their outpatient drug benefit programs . We also found a decrease in utilization of essential drugs with an increase in utilization of nonessential drugs for patients subject to copayments . The results suggest potential adverse effects on patients ’ health outcome This study examined the prescription drug costs of Medicare beneficiaries participating in a Medicaid home- and community-based services ( HCBS ) program and discussed possible implication s of providing a prescription drug benefit under Medicare . The study examined  Medicaid pharmaceutical cl aims data using two r and om sample s ( n=766 ) of dually eligible Medicare beneficiaries in a HCBS program from four regions in Georgia . The average total monthly Medicaid prescription drug expenditure was determined . Annual prescription expenditures for this group averaged more than 1,500 dollars per person . Prescription drugs intended for the treatment of cancer and circulatory disorders combined to account for 61 % of total program drug expenditures . Multivariate analysis found that drug expenditures were higher for those who died during the observation period , the young-old , Caucasians , and those who self-selected into the program . Higher drug expenditures for the self-selected group , even after frailty adjustments , suggest the presence of adverse selection . Medicare prescription drug benefit proposals that rely on voluntary enrollment may also experience adverse selection from frail , low-income beneficiaries This paper estimates how cost-sharing affects the use of prescription drugs . The data for this analysis are derived from the R and Health Insurance Experiment ( HIE ) , a r and omized controlled trial that r and omly assigned participants to insurance plans with varying coinsurance rates and deductibles . Therefore , the cost-sharing they faced was independent of their health and demographic characteristics . The paper used HIE data from four sites to estimate how drug expenditures vary by insurance plan , and to compare the plan response for drugs with that for all ambulatory expenses . The findings show that : ( 1 ) individuals with more generous insurance buy more prescription drugs ; ( 2 ) the cost-sharing response for drugs is similar to the response for all ambulatory medical services ; ( 3 ) the Dayton , Ohio site had significantly greater drug expenditures per capita than the other sites studied and a significantly higher proportion of drugs sold by physicians ; and ( 4 ) the proportion of br and -name drugs among all drugs purchased in pharmacies was not a function of insurance plan . In the Dayton , Ohio site , a significantly higher proportion of the drugs purchased in pharmacies were br and -name rather than generic Little is known about how generosity of insurance and population characteristics affect quantity or appropriateness of antibiotic use . Using insurance cl aims for antibiotics from 5765 non-elderly people who lived in six sites in the United States and were r and omly assigned to insurance plans varying by level of cost-sharing , we describe how antibiotic use varies by insurance plan , diagnosis and health status , geographic area , and demographic characteristics . People with free medical care used 85 % more  antibiotics  than those required to pay some portion of their medical bills ( controlling for all other variables ) . Antibiotic use was significantly more common among women , the very young , patients with poorer health , and persons with higher income .  Use of antibiotics for viral , viral-bacterial , and bacterial conditions did not differ between free and cost-sharing insurance plans , given antibiotics were the treatment of choice . Cost sharing reduced inappropriate and appropriate antibiotic use to a similar degree We studied the effect of  insurance coverage  on the use of emergency department services , using data from a national trial of cost sharing in health insurance . A total of 3973 persons below the age of 62 years were r and omly assigned to fee-for-service health insurance plans with coinsurance rates of 0 , 25 , 50 , or 95 per cent , subject to an income-related upper limit on out-of-pocket expenses . Persons with no cost sharing had emergency department expenses that were 42 per cent higher than those for persons on the 95 per cent plan ( P less than 0.01 ) and about 16 per cent higher than those for persons with smaller amounts of cost sharing . Without cost sharing , emergency department visits for less serious diagnoses ( e.g. , abrasions ) increased three times as much as did visits for more serious diagnoses ( e.g. , lacerations ) . After control for insurance , persons in the lower third of the income distribution had emergency department expenses that were 64 per cent higher than those in the upper third ( P less than 0.001 ) and received a greater proportion of their ambulatory care in the emergency department . We conclude that the absence of cost sharing results in significantly greater emergency department use than does insurance with cost sharing . A disproportionate amount of the increased use involves less serious conditions Objective : This is the first study to compare total Medicare Part D ( MPD ) st and -alone prescription drug plan ( PDP ) estimated annual costs ( EAC ) between 2007 and 2008 in all MPD regions of the US using a patient cohort of Medicare-eligible patients . Methods : A total of 50 patients were selected at r and om from a data base of Medicare-eligible patients . Each patient profile , based on pharmacy cl aims data , was entered into the Medicare website and the EAC of each PDP in each of the 34 MPD regions was obtained . The lowest , 25th percentile , median and highest EAC plans were obtained for each patient in each region for 2007 and 2008 . Pair-wise , within-region , between-year comparisons were made using the Wilcoxon Signed-Ranks test . Results : Annual trends were variable between MPD regions . Only the highest EAC showed significant decreases in some regions , while all other comparisons showed no change or an increase in regional costs . Conclusions : Out-of-pocket Medicare prescription drug costs increased from 2007 to 2008 . Increases in plan costs highlight the need for annual re-evaluation of PDP costs so that the patient is able to obtain the lowest cost plan each year . The decrease in the highest cost plan may suggest improvements in formulary coverage BACKGROUND Mental health disorders represent one of the most common problems facing adults in the labor force . It is estimated that within a 12-month period nearly 30 % of the US population experiences some diagnosable mental health or addictive disorder . This study examines the impact that corporate benefit policies can have on mental health treatment costs . AIMS To measure the effects of a change in mental health benefit design on treatment expenditures for employees of a large US-based company . METHODS Data came from mental health treatment administrative cl aims and eligibility information provided by the company and a comparable set of cl aims for a r and omly selected control group for the years 1995 - 1998 . We measure the effect of a change in mental health benefits consisting of three major elements : a company-wide effort to destigmatize mental illness ; reduced cost-sharing for mental health treatment ; and the implementation of a provider network that emphasized access to non-physician mental health specialists . We use a two-part regression model within a difference in differences framework to examine outpatient , pharmaceutical , and combined outpatient and pharmaceutical expenditures between the treatment company and the control group . RESULTS We find that the program led to a statistically significant dollar 17 increase in outpatient costs ( excluding pharmaceutical costs ) per employee . Similar to outpatient care we find that the benefit change was associated with a statistically significant increase in pharmaceutical costs of about dollar 15 . DISCUSSION The results reveal that the mental health benefit expansion at the company led to a significant increase in aggregate mental health expenditures among employees . However , the aggregate increase in cost masks a number of interesting underlying trends in mental health utilization . First , conditional upon any mental health treatment , mental health costs were virtually unchanged before and after the benefit change . Conditional on any use , outpatient and pharmaceutical expenditures went in opposite directions , with outpatient expenditures falling and pharmaceutical expenditures increasing . IMPLICATION S FOR HEALTH CARE PROVISION AND USE Private sector initiatives can increase use of mental health care treatment through decreased cost-sharing , improved access to specialty providers , and destigmatization of mental disorders . IMPLICATION S FOR HEALTH CARE POLICY FORMULATION : Given that the vast majority of people in the US get their health insurance through employer-sponsored health insurance , efforts on the part of the private sector to recognize and treat serious chronic illnesses such as mental disorder in a proactive manner should be encouraged . IMPLICATION S FOR FUTURE RESEARCH While the aggregate cost of corporate initiatives to improve access to quality mental health care is frequently examined , it is also important to decompose the aggregate cost changes into effects from a change in the rate of initiation and changes in utilization conditional upon initiation Context In 2006 ,  Medicare  inaugurated a  drug benefit for older adults . Contribution Using data from a r and om sample of pharmacy customers who were beneficiaries of the program after the enrollment deadline , the authors estimate that the drug benefit saved people about $ 9 a month and gave them an extra 14 days of pills , on average . Caution The authors did not examine effects of the doughnut hole and did not look at specific drugs or drug classes . Implication The Medicare drug benefit has led to modest decreases in expense and increases in drug use for older adults . The Editors The Medicare Modernization Act Prescription Drug Benefit ( Part D ) established a prescription drug benefit for all 43 million Medicare beneficiaries in the United States . This is the largest change to Medicare since the program began several decades ago ( 1 ) . The prescription benefit has increased the proportion of Medicare enrollees with prescription drug coverage ( 2 ) , and the Centers for Medicaid & Medicare Services report that among seniors eligible for Medicare , Part D enrollees save on out-of-pocket expenses compared with those not enrolled in Part D ( 3 , 4 ) . Previous reports also have examined enrollment and used surveys to examine beneficiaries ' beliefs and experiences ( 57 ) . Although these reports and others ( 8 , 9 ) point to positive effects of the Part D benefit , several questions remain unanswered about its overall effect on prescription utilization and expenditures . This is because studies have tended to focus only on beneficiaries who have enrolled in a Medicare Part D plan . Changes in drug utilization or expenditures measured in these studies could represent Part D coverage , trends in prescription drug use unrelated to Part D , or differences between beneficiaries who enrolled in Part D and those who did not . A 2004 projection suggested that the Medicare drug benefit would reduce average out-of-pocket expenditures by about 14 % among elderly persons with Medicare coverage and by about 47 % among elderly persons without preexisting drug coverage , result ing in an overall increase in total drug spending of about 6 % ( 10 ) . This prediction was mainly driven by the fact that almost three fourths of elderly persons in the United States already had some kind of drug coverage and that Medicare Part D would have a small effect on their expenditures and utilization . Yet with the exception of 1 recent study ( 11 ) , little work has been done to empirically estimate the effect of the Part D benefit on prescription drug utilization and expenditures . We sought to address these limitations by analyzing pharmacy cl aims from a national pharmacy chain accounting for approximately one eighth of the market share of prescription medicines in the United States . Although this sample may not be nationally representative , it offers an opportunity to study the effect of Part D on a broad and heterogeneous population that accounts for a substantial portion of the entire Medicare population . Our analyses compare the effect of Part D on prescription drug utilization and expenditures among persons eligible for the benefit who enrolled in a Part D plan , persons eligible for the benefit who did not enroll , and noneligible persons . We also distinguish between the overall effect of Part D during the penalty-free enrollment period and the postpenalty-free period , when enrollment was stable , to determine the steady-state effect of Part D , independent of enrollment dynamics . Methods Sample and Measurements We selected a 5 % r and om sample of unique pharmacy customers who filled at least 1 prescription during both the 2005 and the 2006 calendar years through the Walgreens pharmacy chain , whether at a retail store or by mail order . For each person in our sample , we obtained cl aims data for every prescription filled between 1 September 2004 and 31 April 2007 . For each prescription cl aim , we obtained data on the cl aim ant 's demographic characteristics ( age , sex , language preference , ZIP code of residence ) , insurance characteristics ( whether the cl aim was paid through a prescription drug plan , method of payment ) , pharmacy characteristics ( ZIP code location ) , prescription characteristics ( National Drug Code , therapeutic class , drug dose , number of treatment days , date dispensed , number of refills ) , and expenditures ( amount paid out of pocket , amount paid by third party ) . We used data on cl aim ants ' ZIP code of residence  ( the residence recorded at the person 's first pharmacy cl aim in 2005 ) to link the pharmacy cl aims data to data from the 2000 U.S. Census , including information on the total population , median household income , income per capita , proportion of urban residents , proportion of African-American persons , unemployment rate , and poverty rate within the ZIP code of residence ( 12 , 13 ) . We also used data from the Behavioral Risk Factor Surveillance System ( BRFSS ) to compare the characteristics of our sample with those of all Medicare beneficiaries . We used simple descriptive statistics to compare the age and sex distribution of our sample with those of persons age 60 to 63 years and 66 to 79 years in the BRFSS . We also linked BRFSS data to 2000 U.S. Census data to examine whether the ZIP codelevel demographic characteristics of our pharmacy sample were similar to those of the nationally representative BRFSS sample in the same age groups , and whether the characteristics of our sample were similar to those of only BRFSS respondents who lived in the same geographic areas as our pharmacy sample . We excluded persons 80 years of age or older because the proportion of persons in nursing homes is higher among this age group and because changes in the Medicare Modernization Act regarding persons receiving nursing home care and long-term care ( 14 ) do not extend to the majority of the Medicare population . Outcomes Our 2 outcomes were monthly average out-of-pocket prescription costs and prescription utilization , as measured by the quantity of a prescription medicine sufficient for 1 day of therapy ( pill-day ) . Each person in our sample contributed 32 observations corresponding to 32 months of data . We divided the 32 months into 3 periods : the prePart D period ( September 2004 to December 2005 ) ; the ramp-up postPart D period , during which seniors could enroll in Part D plans without penalty ( January 2006 to May 2006 ) ; and the stable postPart D period , after the deadline for penalty-free Part D enrollment ( June 2006 to April 2007 ) . Because we aim ed to estimate the effect of Part D , we sought to compare observed trends in out-of-pocket costs and utilization among seniors eligible for the benefit ( the Part Deligible group , consisting of persons age 66 to 79 years as of 1 January 2006 ) with predicted counterfactual trends for the same group of seniors had Part D not been enacted . Thus , we sought to estimate the effect of Part D on expenditures and utilization netting out contemporaneous changes to the outcome variable due to factors unrelated to Part D ( 15 , 16 ) . To estimate counterfactual trends , we used the contemporaneous time profile of the corresponding outcomes in a control group of persons age 60 to 63 years who were not yet eligible for the benefit ( the Part Dineligible group ) . We dropped persons ages 64 and 65 years as of 1 January 2006 from the sample because they had partial-year Medicare eligibility during the study period . We first confirmed that the trends in outcomes in persons 60 to 63 years of age provided an adequate control for persons in the eligible group during the prePart D era ( September 2004 to December 2005 ) by examining both the statistical significance and magnitude of the coefficients in our regression model that represented the differential trends between the Part Deligible and Part Dineligible groups during the prePart D era . We then used the counterfactual control trends in the ramp-up period and in the stable enrollment period after the Part D enrollment deadline in May 2006 to represent the counterfactual trends in outcomes for the Part Deligible group assuming Part D had not been enacted . Statistical Analysis We estimated trends and generated predictions by using generalized estimating equations ( GEEs ) . We adjusted for sample demographic characteristics ( sex , English-speaking status , Medicaid coverage , age ) , ZIP codelevel characteristics ( total population , median household income , per-capita income , proportion of urban residents , proportion of African-American persons , unemployment rate , poverty rate ) , fixed effects for calendar months ( January to December ) , study period ( prePart D , ramp-up postPart D , and stable postPart D ) , and Part Deligible group . Moreover , we explored a variety of splines for representing differential time trends between periods ; we ultimately used cubic splines because they produced the best fit for both the prePart D and the stable postPart D periods . A linear spline was used for the ramp-up postPart D period because this period was short . We added up to 3-way interactions between study period and Part Deligible group fixed effects and the splines over time . We assessed overall model fit by using a variety of goodness-of-test criteria . We used gamma distribution to model out-of-pocket expenditures and negative binomial distribution to model pill-days . All estimators used log-link models . In addition , we explored the correlation structure between monthly observations within participants and used a first-order autoregressive correlation structure for out-of-pocket costs and an unstructured correlation matrix for pill-days . We had 2 main goals . First , we sought to estimate the policy effect of Part D coverage during both the ramp-up and stable postPart D periods . These effects represent the mean differences in the monthly outcomes between the observed factual trends and predicted counterfactual trends if Part D had not been enacted over these 2 periods . The Appendix Figure provides details about the specifications of these models and how the BACKGROUND Prior studies of the Medicare Part D coverage gap are limited in generalizability and scope . OBJECTIVE To determine the effect of the coverage gap on drugs used for asymptomatic ( antihypertensive and lipid-lowering drugs ) and symptomatic ( pain relievers , acid suppressants , and antidepressants ) conditions in elderly patients with hypertension and hyperlipidemia . DESIGN Quasi-experimental study using pre-post design and contemporaneous control group . SETTING Medicare cl aims files from 2005 and 2006 for 5 % r and om sample of Medicare beneficiaries . PATIENTS Part D plan enrollees with hypertension or hyperlipidemia aged 65 years or older who had no coverage , generic-only coverage , or both br and -name and generic coverage during the gap in 2006 . Patients who were fully eligible for the low-income subsidy served as the control group . MEASUREMENTS Monthly 30-day supply prescriptions available , medication adherence , and continuous medication gaps of 30 days or more for  antihypertensive or lipid-lowering drugs ; monthly 30-day supply prescriptions available  for pain relievers , acid suppressants , or antidepressants  before and after coverage gap entry . RESULTS Patients with no gap coverage had a decrease in monthly antihypertensive and lipid-lowering drug prescriptions during the coverage gap . Nonadherence also increased in this group ( antihypertensives : odds ratio [ OR ] , 1.60 [ 95 % CI , 1.50 to 1.71 ] ; lipid-lowering drugs : OR , 1.59 [ CI , 1.50 to 1.68 ] ) . The proportion of patients with no gap coverage who had continuous medication gaps in lipid-lowering medication use and antihypertensive use increased by an absolute 7.3 % ( OR , 1.38 [ CI , 1.29 to 1.46 ] ) and 3.2 % ( OR , 1.35 [ CI , 1.25 to 1.45 ] ) , respectively , because of the coverage gap . Decreases in use were smaller for pain relievers and antidepressants and larger for acid suppressants in patients with no gap coverage . Patients with generic-only coverage had decreased use of cardiovascular medications but no change in use of drugs for symptomatic conditions . No measures changed in the br and -name and generic coverage groups . Results of sensitivity analyses were consistent with the main findings . LIMITATION Because this study was nonr and omized , unobserved differences may still exist between study groups . CONCLUSION The Part D coverage gap was associated with decreased use of medications for hypertension and hyperlipidemia in patients with no gap coverage and generic-only gap coverage . The proposed phasing out of the gap by 2020 will benefit such patients ; however , use of low-value medications may also increase . PRIMARY FUNDING SOURCE Penn-Pfizer Alliance and American Heart Association
target: Increasing the amount of money that people pay for medicines may reduce insurers ' medicine expenditures and may reduce patients ' medicine use .
  These types of interventions may lead to small decreases in or uncertain effects on healthcare utilisation .
  Cap and co-payment polices may reduce the use of medicines and reduce medicine expenditures for health insurers .
  However , they may also reduce the use of life-sustaining medicines or medicines that are important in treating chronic , including symptomatic , conditions and , consequently , could increase the use of healthcare services .
  Fixed co-payment with a ceiling and tiered fixed co-payment may be less likely to reduce the use of essential medicines or to increase the use of healthcare services
background: BACKGROUND Growing expenditures on prescription medicines represent a major challenge to many health systems .
  Cap and co-payment policies are intended as an incentive to deter unnecessary or marginal utilisation , and to reduce third-party payer expenditures by shifting parts of the financial burden from insurers to patients , thus increasing their financial responsibility for prescription medicines .
  Direct patient payment policies include caps ( maximum numbers of prescriptions or medicines that are reimbursed ) , fixed co-payments ( patients pay a fixed amount per prescription or medicine ) , co-insurance ( patients pay a percentage of the price ) , ceilings ( patients pay the full price or part of the cost up to a ceiling , after which medicines are free or are available at reduced cost ) and tier co-payments ( differential co-payments usually assigned to generic and br and medicines ) .
  This is the first up date of the original review .
  OBJECTIVES To determine the effects of cap and co-payment ( cost-sharing ) policies on use of medicines , healthcare utilisation , health outcomes and costs ( expenditures ) .