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2.  Medicare Part D Plan Generosity and Medication Use among Dual Eligible Nursing Home Residents 
Medical care  2013;51(10):894-900.
Background
In 2006, dual-eligible nursing home residents were randomly assigned to a Medicare Part D prescription drug plan (PDP). Subsequently, residents not enrolled in qualified plans at the start of the next year were re-randomized. PDPs vary in generosity through differences in medication coverage and utilization management. Therefore, residents’ assigned plans may be relatively more or less generous for their particular drugs. The impact of generosity on residents’ medication use and health outcomes is unknown.
Methods
Using 2005–2008 data, we estimate logistic regression models of the impact of coverage and utilization management on the risk for medication changes and gaps in use, hospitalizations, and death among elderly nursing home residents using one of six drug classes, adjusting for patient characteristics.
Results
Few current medication users faced non-coverage of their drug (0.4%–8.7%) or prior authorization or step therapy requirements if the drug was covered (1.1%–37.4%). After adjusting for individual-level covariates, residents with non-covered drugs were more likely than residents with covered drugs to change medications in most classes studied (e.g., for 2006 angiotensin receptor blocker users, the adjusted average probability of medication change was 0.35 when uncovered vs. 0.11 when covered). Those subject to prior authorization or step therapy were more likely to change in a subset of classes. There were no statistically-significant differences in rates of hospitalization or death after correcting for multiple comparisons.
Conclusions
The Part D benefit’s special protections for nursing home residents may have ameliorated the health impact of coverage limits on this frail elderly population.
doi:10.1097/MLR.0b013e31829fafdc
PMCID: PMC3773176  PMID: 24025658
Part D; plan generosity; nursing home; dual eligible
3.  The Effects of Parity on Mental Health and Substance Use Disorder Spending and Utilization: Does Diagnosis Matter? 
The American journal of psychiatry  2013;170(2):180-187.
Objective
The Mental Health Parity and Addiction Equity Act (MHPAEA) requires insurance parity for mental health/substance use disorder (MH/SUD) and general medical services. Prior research found that parity did not increase MH/SUD spending and lowered out-of-pocket spending. Whether parity’s effects differ by diagnosis is unknown. We examine this question in the context of parity implementation in the Federal Employees Health Benefit (FEHB) Program.
Methods
Using administrative data and a difference-in-difference design, we compared MH/SUD treatment use and spending before (2000) and after (2002) parity for FEHB enrollees diagnosed in 1999 with bipolar disorder, major depression, or adjustment disorder (N=19,094) to that for a national sample of privately-insured individuals unaffected by the policy (N=10,521). Separate models were fit for each diagnostic group.
Results
The parity directive resulted in total spending that was unchanged among MH/SUD users with bipolar disorder and major depression but decreased for adjustment disorder (−$114 [95% CI:−$193,−$41]). Out-of-pocket spending decreased by a comparable amount for all three diagnoses (range: −$78 to −$86). Total annual utilization (e.g., medication management visits, psychotropic prescriptions, and MH/SUD hospitalization bed days) remained unchanged across all diagnoses. Annual psychotherapy visits decreased significantly only for individuals with adjustment disorders (−12%[−17.0%,−6.1%]).
Conclusions
While parity implemented in the context of managed care improved financial protection for individuals in all three diagnostic groups, the policy differentially affected spending and psychotherapy utilization across groups. There was some evidence that resources were preferentially preserved for diagnoses typically more severe/chronic and reduced for diagnoses that are expected to be less so.
doi:10.1176/appi.ajp.2012.12030392
PMCID: PMC4169195  PMID: 23377639
4.  Technology diffusion in the antipsychotic market: a comparison of France and the USA between 1998 and 2008 
Objective
Second generation antipsychotics captured the majority of the US antipsychotic market shortly after their introduction. Little is known about how second generation antipsychotics diffused in other countries with different health systems. The objective was to describe trends in antipsychotic use in the US and France from 1998 to 2008.
Methods
After presenting a brief background section on pharmaceutical policies in France and the US, descriptive data on quarterly prescriptions dispensed between 01/1998–09/2008 for oral antipsychotics from Xponent™ for the US, and sales recorded in the GERS database for France are presented. Trends in the share of antipsychotic use for first vs. second generation antipsychotics, and in ingredient-level of second generation antipsychotics use are reported.
Results
In the US, between 1998 and 2008, total antipsychotic use increased by 78%. Total use was consistently higher in France despite a 9% decrease during the period. By 2008, second generation antipsychotics represented 90% of the antipsychotic US market vs. only 40% in France. However, average annual growth rates in second generation antipsychotics use were similar in the two countries. In France, there was a steady increase in use of all but one second generation antipsychotic; whereas trends in the use of newer drugs varied substantially by drug in the US (e.g. use of olanzapine decreased after 2003 whereas use of quetiapine increased).
Conclusions
These results highlight markedly divergent trends in the diffusion of new antipsychotics in France and the US. Some of these differences may be explained by differences in health systems, while others may reflect physicians’ preferences and norms of practice.
doi:10.1176/appi.ps.004662012
PMCID: PMC4102178  PMID: 23584568
5.  The Effect of Medicare Part D on Guideline-Concordant Pharmacotherapy for Bipolar I Disorder among Dually Enrolled Beneficiaries 
Objective
In January 2006 drug insurance coverage shifted from Medicaid to Medicare Part D private drug plans for the 6 million individuals enrolled in both programs. Beneficiaries faced new formularies and utilization management policies. It is uncertain if Part D, when compared to Medicaid, relaxed or tightened psychiatric medication management, which could affect receipt of recommended pharmacotherapy, and emergency department use related to treatment discontinuities. This study examined the impact of the transition from Medicaid to Part D on guideline-concordant pharmacotherapy for bipolar I disorder and emergency department use.
Methods
Using interrupted time series and Medicaid and Medicare administrative data from 2004–2007, the authors analyzed the effect of the coverage transition on receipt of guideline-concordant anti-manic medication, guideline-discordant antidepressant monotherapy, and emergency department visits for a nationally-representative continuous cohort of 1,431 adults diagnosed with bipolar I disorder.
Results
Sixteen months after the transition, the proportion of the population with any recommended anti-manic use was an estimated 3.1 percentage points higher than expected controlling for baseline trends. The monthly proportion of beneficiaries with 7+ days of antidepressant monotherapy was 2.1 percentage points lower than expected. The number of emergency department visits per month increased by 19% immediately post-transition.
Conclusions
Increased receipt of guideline-concordant pharmacotherapy for bipolar I disorder may reflect relatively less restrictive management of anti-manic medications under Part D. The clinical significance of these changes is unclear given the small effect sizes. However, increased emergency department visits merit attention for the Medicaid beneficiaries who continue to transition to Part D.
doi:10.1176/appi.ps.201300123
PMCID: PMC4038978  PMID: 24337444
6.  Effects of FDA Advisories on the Pharmacologic Treatment of ADHD, 2004–2008 
Objective
This study assessed the effect of public health advisories issued between 2005 and 2007 by the U.S. Food and Drug Administration (FDA) on treatments of attention-deficit hyperactivity disorder (ADHD) and physician prescribing practices.
Methods
Data obtained from the IMS Health National Disease and Therapeutic Index, a nationally representative audit of ambulatory physicians, were used to examine trends in office visits by children and adolescents (under age 18) during which ADHD was treated with Adderall, other psychostimulants, or atomoxetine. Segmented time series regressions were conducted to determine changes in use associated with three advisories issued between 2005 and 2007.
Results
In 2004, before the first FDA advisory, Adderall accounted for 36% of ADHD pharmacotherapy treatment visits. Other stimulants accounted for 46%, and atomoxetine accounted for 19%. Overall pharmacotherapy treatment rates were stable over the study period, but by 2008 the treatment visits accounted for by Adderall (that is, market share) declined to 24%, and the market share for atomoxetine declined to 8%. The market share for substitute therapies—clonidine, guanfacine, and bupropion—was stable over this period, ranging from 5% to 7%. Despite the declines in the use of Adderall and atomoxetine over the study period, results from the regression models suggest that the advisories did not have a statistically significant effect on ADHD medication prescribing.
Conclusions
FDA advisories regarding potential cardiovascular and other risks of ADHD medications had little discernible incremental effect on the use of these medicines in this nationally representative ambulatory audit.
doi:10.1176/appi.ps.201200147
PMCID: PMC4023684  PMID: 23318985
7.  How quickly do physicians adopt new drugs? The case of second-generation antipsychotics 
Objective
To examine physician adoption of second-generation antipsychotic medications and identify physician-level factors associated with early adoption.
Methods
Using IMS Health Xponent™ data, which captures over 70% of all prescriptions filled in the U.S., and AMA Masterfile data on prescriber characteristics for each of 9 second-generation antipsychotics introduced from 1996–2008 for 30,369 physicians who prescribed antipsychotics, we estimate drug-specific Cox proportional hazards models of time to adoption and conduct descriptive analysis of the total number of agents prescribed.
Results
On average, physicians waited two or more years before prescribing new second-generation antipsychotics, but there was substantial heterogeneity across products in time to adoption. General practitioners were much slower to adopt second-generation antipsychotics than psychiatrists (hazard ratios (HRs) ranged from 0.10–0.35); solo practitioners were slower to adopt most products than group practitioners (HRs ranged from 0.77–0.89). Physicians in the highest quartile of antipsychotic prescribing volume adopted second-generation antipsychotics much faster than physicians in the lowest quartile (HRs ranged from 0.15–0.39). Psychiatrists tended to prescribe a broader set of antipsychotics (median of 6) than other specialties (median of 2 for general practitioners and neurologists and 1 for pediatricians).
Conclusions
Policymakers are searching for ways to control rapid health spending growth, which is driven primarily by use of new technologies such as second-generation antipsychotics. Understanding the factors that influence physician adoption of new medications will be crucial in the implementation of efforts aimed at maximizing value of care received by individuals with mental disorders as well as efforts to improve medication safety.
doi:10.1176/appi.ps.201200186
PMCID: PMC3907700  PMID: 23280376
prescription drugs; mental health; antipsychotics
8.  Parity and Out-of-Pocket Spending for Children With High Mental Health or Substance Abuse Expenditures 
Pediatrics  2013;131(3):e903-e911.
OBJECTIVE:
The Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act required health plans to provide mental health and substance use disorder (MH/SUD) benefits on par with medical benefits beginning in 2010. Previous research found that parity significantly lowered average out-of-pocket (OOP) spending on MH/SUD treatment of children. No evidence is available on how parity affects OOP spending by families of children with the highest MH/SUD treatment expenditures.
METHODS:
We used a difference-in-differences study design to examine whether parity reduced families’ (1) share of total MH/SUD treatment expenditures paid OOP or (2) average OOP spending among children whose total MH/SUD expenditures met or exceeded the 90th percentile. By using claims data, we compared changes 2 years before (1999–2000) and 2 years after (2001–2002) the Federal Employees Health Benefits Program implemented parity to a contemporaneous group of health plans that did not implement parity over the same 4-year period. We examined those enrolled in the Federal Employees Health Benefits Program because their parity directive is similar to and served as a model for the new federal parity law.
RESULTS:
Parity led to statistically significant annual declines in the share of total MH/SUD treatment expenditures paid OOP (−5%, 95% confidence interval: −6% to −4%) and average OOP spending on MH/SUD treatment (−$178, 95% confidence interval: −257 to −97).
CONCLUSIONS:
This study provides the first empirical evidence that parity reduces the share and level of OOP spending by families of children with the highest MH/SUD treatment expenditures; however, these spending reductions were smaller than anticipated and unlikely to meaningfully improve families’ financial protection.
doi:10.1542/peds.2012-1491
PMCID: PMC3581843  PMID: 23420919
mental health; substance use disorder; parity; insurance
9.  Trends in Co-Prescribing of Antidepressants and Tamoxifen among Women with Breast Cancer, 2004 – 2010 
Introduction
Nearly a decade ago, researchers identified a potential interaction between tamoxifen and strong CYP2D6 inhibitors, including several frequently used antidepressants. Based on evidence available at that time, a United States Food and Drug Administration advisory committee recommended tamoxifen’s label be changed in October 2006, noting that postmenopausal women with estrogen receptor-positive breast cancer who are poor CYP2D6 metabolizers by genotype or drug interactions may be at increased risk of cancer recurrence. The impact of accumulating drug risk information on antidepressant use is unknown.
Methods
Retrospective, longitudinal cohort study of 13,205 women aged 50–95 with breast cancer initiating tamoxifen between July 2004–December 2009. We evaluate trends in strong, moderate, and weak CYP2D6-inhibitor antidepressants and tamoxifen co-prescribing and factors associated with ongoing strong inhibitor use. A propensity-score matched control group (aromatase inhibitor initiators) was used to estimate changes in co-prescribing, accounting for secular trends.
Results
In each month, approximately 24% of tamoxifen and aromatase inhibitor users were prescribed antidepressants. Among women using tamoxifen and antidepressants, 34% used strong inhibitors between 2004 and 2006 versus 15% in 2010. Strong inhibitor use decreased more among tamoxifen users than aromatase inhibitor users (Difference-in-Differences, [DD]: −0.09, 95% Confidence Interval, [CI]: −0.15, −0.03). Weak inhibitor use increased among tamoxifen users from 32% between 2004 and 2006 to 52% in 2010, more rapidly than among aromatase inhibitor users (DD:0.15, CI:0.08, 0.23). The factor most strongly associated with strong inhibitor and tamoxifen co-prescribing after 2006 was prior strong inhibitor use (RR:4.73, CI:3.62–6.18).
Conclusion
There were substantial declines in strong CYP2D6-inhibitor use among tamoxifen users following dissemination of information suggesting a potential for increased risk with co-prescribing. Whether patients and providers will continue to avoid strong inhibitor antidepressants is yet to be seen, but clinicians appear to be responsive to drug interaction risk information in this setting.
doi:10.1007/s10549-012-2330-z
PMCID: PMC3529777  PMID: 23149465
Tamoxifen; CYP2D6; drug interaction; FDA Advisories; drug utilization
10.  Racial-Ethnic Differences in Incident Olanzapine Use After an FDA Advisory for Patients With Schizophrenia 
Objective
Prior investigations suggest that olanzapine use declined rapidly after a U.S. Food and Drug Administration (FDA) communication and consensus statement warning of the drug’s increased metabolic risks, but whether declines differed by racial-ethnic groups is unknown.
Methods
Changes in olanzapine use over time by race-ethnicity was assessed among 7,901 Florida Medicaid enrollees with schizophrenia.
Results
Prior to the advisory, 57% of second-generation antipsychotic fills among Hispanics were for olanzapine, compared with 40% for whites or blacks (adjusted risk difference [ARD]=.17, 95% confidence interval [CI]=.13–.20). Olanzapine use declined among all racial-ethnic groups. Although Hispanics had greater olanzapine use than whites in each period, the differences in absolute risk were only 3% by the latest study period (ARD=.03, CI=.01–.04).
Conclusions
After the FDA communication and consensus statement were issued, differences in olanzapine use between white and Hispanic enrollees narrowed considerably. Identifying high-use subgroups for targeted delivery of drug safety information may help eliminate any existing differences in prescribing.
doi:10.1176/appi.ps.201200002
PMCID: PMC3572912  PMID: 23280461
11.  Associations Between End-of-Life Discussion Characteristics and Care Received Near Death: A Prospective Cohort Study 
Journal of Clinical Oncology  2012;30(35):4387-4395.
Purpose
National guidelines recommend that discussions about end-of-life (EOL) care planning happen early for patients with incurable cancer. We do not know whether earlier EOL discussions lead to less aggressive care near death. We sought to evaluate the extent to which EOL discussion characteristics, such as timing, involved providers, and location, are associated with the aggressiveness of care received near death.
Patients and Methods
We studied 1,231 patients with stage IV lung or colorectal cancer in the Cancer Care Outcomes Research and Surveillance Consortium, a population- and health system–based prospective cohort study, who died during the 15-month study period but survived at least 1 month. Our main outcome measure was the aggressiveness of EOL care received.
Results
Nearly half of patients received at least one marker of aggressive EOL care, including chemotherapy in the last 14 days of life (16%), intensive care unit care in the last 30 days of life (9%), and acute hospital-based care in the last 30 days of life (40%). Patients who had EOL discussions with their physicians before the last 30 days of life were less likely to receive aggressive measures at EOL, including chemotherapy (P = .003), acute care (P < .001), or any aggressive care (P < .001). Such patients were also more likely to receive hospice care (P < .001) and to have hospice initiated earlier (P < .001).
Conclusion
Early EOL discussions are prospectively associated with less aggressive care and greater use of hospice at EOL.
doi:10.1200/JCO.2012.43.6055
PMCID: PMC3675701  PMID: 23150700
12.  Changes in Antipsychotic Use among Patients with Severe Mental Illness after an FDA Advisory 
Pharmacoepidemiology and drug safety  2012;21(12):1251-1260.
Purpose
A 2003 FDA advisory warned of increased hyperlipidemia and diabetes risk for patients taking second-generation antipsychotics (SGAs). Following the advisory a professional society consensus statement provided treatment recommendations and stratified SGAs into high, intermediate, and low metabolic risk. We examine subsequent changes in incident and prevalent SGA use among individuals with severe mental illness.
Methods
Retrospective, observational study using Florida Medicaid’s claims from 2001–2006. We include non-Medicare eligible adults with bipolar disorder or schizophrenia who filled a SGA prescription. Among prevalent users we assess changes in overall and agent-specific use; discontinuations; interruptions; and therapeutic alternative use; among incident users, agent-specific use. Pre-advisory utilization was compared with utilization initially following the advisory and two subsequent periods.
Results
Among prevalent users, overall SGA use declined slightly and no increases in treatment interruptions or discontinuations were observed following the advisory and consensus statement publication. Compared with the pre-advisory period, in the months immediately following use of the highest metabolic-risk agent, olanzapine, decreased by 34% among prevalent users with bipolar disorder (adjusted risk ratio [aRR]=0.66; 95% confidence intervals [CI]=0.59–0.74) and 26% among prevalent users with schizophrenia (aRR=0.74, CI=0.72–0.76). A greater decline was estimated among incident users with bipolar disorder (aRR=0.37; CI=0.29–0.47) and schizophrenia (aRR=0.42; CI=0.35–0.51) during this period. During each subsequent post-advisory period, olanzapine use continued to decline while quetiapine, ziprasidone, and aripiprazole use increased.
Conclusions
The metabolic risk advisory and published consensus statement were associated with a selective reduction in olanzapine use without evidence of treatment disruptions among this population.
doi:10.1002/pds.3272
PMCID: PMC3431449  PMID: 22553074
Drug Utilization; FDA Advisory; Metabolic Risk; Second Generation Antipsychotics
13.  Medicare Part D Claims Rejections for Nursing Home Residents, 2006 to 2010 
Objectives
Much has been written about trends in Medicare Part D formulary design and consumers’ choice of plans, but little is known about the magnitude of claims rejections or their clinical and administrative implications. Our objective was to study the overall rate at which Part D claims are rejected, whether these rates differ across plans, drugs, and medication classes, and how these rejection rates and reasons have evolved over time.
Study Design and Methods
We performed descriptive analyses of data on paid and rejected Part D claims submitted by 1 large national long-term care pharmacy from 2006 to 2010. In each of the 5 study years, data included approximately 450,000 Medicare beneficiaries living in long-term care settings with approximately 4 million Part D drug claims. Claims rejection rates and reasons for rejection are tabulated for each study year at the plan, drug, and class levels.
Results
Nearly 1 in 6 drug claims was rejected during the first 5 years of the Medicare Part D program, and this rate has increased over time. Rejection rates and reasons for rejection varied substantially across drug products and Part D plans. Moreover, the reasons for denials evolved over our study period. Coverage has become less of a factor in claims rejections than it was initially and other formulary tools such as drug utilization review, quantity-related coverage limits, and prior authorization are increasingly used to deny claims.
Conclusions
Examining claims rejection rates can provide important supplemental information to assess plans’ generosity of coverage and to identify potential areas of concern.
PMCID: PMC3540110  PMID: 23145808
14.  Economic Grand Rounds 
The impact of parity coverage on the quantity of behavioral health services used by enrollees and on the prices of these services was examined in a set of Federal Employees Health Benefit (FEHB) Program plans. After parity implementation, the quantity of services used in the FEHB plans declined in five service categories, compared with plans that did not have parity coverage. The decline was significant for all service types except inpatient care. Because a previous study of the FEHB Program found that total spending on behavioral health services did not increase after parity implementation, it can be inferred that average prices must have increased over the period. The finding of a decline in service use and increase in prices provides an empirical window on what might be expected after implementation of the federal parity law and the parity requirement under the health care reform law.
doi:10.1176/appi.ps.20120p107
PMCID: PMC3773179  PMID: 22302324
15.  New Jersey’s Efforts To Improve Postpartum Depression Care Did not Change Treatment Patterns for Women on Medicaid 
Health affairs (Project Hope)  2011;30(2):293-301.
Identification and treatment of postpartum depression are the increasing focus of state and national legislation, including portions of the Affordable Care Act. Some state policies and proposals are modeled directly on programs in New Jersey, the first state to require universal screening of mothers who recently delivered babies for postpartum depression. We examined the impact of these policies on a particularly vulnerable population, Medicaid recipients, and found that neither the required screening, nor the educational campaign that preceded it, was associated with improved treatment initiation, follow-up, or continued care. We argue that New Jersey’s policies, although well intentioned, were predicated on an inadequate base of evidence, and that efforts should now be undertaken to build that base. We also argue that, to improve detection and treatment, policy makers contemplating or implementing postpartum depression mandates should consider additional measures. These could include requiring mechanisms to monitor and enforce the screening requirement; payment of providers to execute screening and follow up; and preliminary testing of interventions before policy changes are enacted.
doi:10.1377/hlthaff.2009.1075
PMCID: PMC3736568  PMID: 21289351
16.  Racial and Ethnic Disparities in Postpartum Depression Care Among Low-Income Women 
Objective
The goal of this study was to characterize racial-ethnic differences in mental health care utilization associated with postpartum depression in a multiethnic cohort of Medicaid recipients.
Methods
In a retrospective cohort study, administrative claims data from New Jersey’s Medicaid program were obtained for 29,601 women (13,001 whites, 13,416 blacks, and 3,184 Latinas) who delivered babies between July 2004 and October 2007. Racial-ethnic differences were estimated with logistic regression for initiation of antidepressant medication or outpatient mental health visits within six months of delivery, follow-up (a prescription refill or second visit), and continued mental health care (at least three visits or three filled antidepressant prescriptions within 120 days).
Results
Nine percent (N=1,120) of white women initiated postpartum mental health care, compared with 4% (N=568) of black women and 5% (N=162) of Latinas. With analyses controlling for clinical factors, the odds of initiating treatment after delivery were significantly (p<.001) lower for blacks (adjusted odds ratio [AOR]=.43) and Latinas (AOR=.59) compared with whites. Among those who initiated treatment, blacks and Latinas were less likely than whites to receive follow-up treatment (blacks, AOR=.66, p<.001; Latinas, AOR=.67, p<.05) or continued care (blacks, AOR=.81, marginal difference at p<.10; Latinas, AOR=.67, p<.05). Among those who initiated antidepressant treatment, black women and Latinas were less likely than whites to refill a prescription.
Conclusions
There were significant racial-ethnic differences in depression-related mental health care after delivery. Suboptimal treatment was prevalent among all low-income women in the study. However, racial and ethnic disparities in the initiation and continuation of postpartum depression care were particularly troubling and warrant clinical and policy attention.
doi:10.1176/appi.ps.62.6.619
PMCID: PMC3733216  PMID: 21632730
17.  Association Between the Part D Coverage Gap and Adverse Health Outcomes 
Background
Part D coverage gap entry is associated with a two-fold increased rate of drug discontinuation among beneficiaries now fully responsible for drug costs. Reduced adherence to drugs has been associated with adverse outcomes. We evaluated whether coverage gap entry is associated with risk of death or hospitalization for cardiovascular outcomes.
Design
Prospective cohort study. Beneficiaries entered the study upon reaching the coverage gap spending threshold and were observed until an event, reaching the threshold for catastrophic coverage, or year’s end. Exposed patients were responsible for drug costs in the gap; unexposed patients received financial assistance. We matched 9,436 exposed patients to 9,436 unexposed patients based on propensity score (PS) or high-dimensional propensity score (hdPS).
Setting
Medicare Part D drug insurance.
Participants
303,978 Medicare beneficiaries aged 65+ in 2006 and 2007 with linked prescription and medical claims who enrolled in stand-alone Part D or retiree drug plans and reached the gap spending threshold.
Measurements
Rates of death and hospitalization for any of 5 cardiovascular outcomes, including acute coronary syndrome+revascularization (ACS), after reaching the coverage gap spending threshold were compared using Cox proportional hazards models.
Results
In PS-matched analyses, exposed beneficiaries had elevated but non-significant hazards of death (HR=1.25; 95% CI 0.98–1.59) and ACS (HR=1.16; 0.83–1.62) compared with unexposed patients. hdPS-matched analyses minimized residual confounding and confirmed results: death (HR=0.99; 0.78–1.24); ACS (HR=1.07; 0.81–1.41). Exposed beneficiaries were no more or less likely to experience other outcomes than were the unexposed.
Conclusions
During the short-term coverage gap period, having no financial assistance to pay for drugs was not associated with an increased risk of death or hospitalization for cardiovascular causes. However, long-term health consequences remain unclear.
doi:10.1111/j.1532-5415.2012.04073.x
PMCID: PMC3419279  PMID: 22788544
Medicare Part D; coverage gap; adverse health outcomes; cardiovascular disease; drug discontinuation
18.  Uninsurance and its Correlates among Poor Adults with Disabilities 
States must offer Medicaid coverage to poor adults with disabilities; however, they have discretion in the design of eligibility criteria and enrollment processes. Using the American Community Survey, we examined the health insurance status of adults enrolled in the Supplemental Security Income (SSI) disability program including (1) the national rate of health insurance coverage; (2) state rates of uninsurance and Medicaid; and (3) the correlates of uninsurance. Uninsurance and Medicaid rates varied across states from 1% to 12% and from 63% to 91%, respectively. Nationally, 5% of the SSI population was uninsured; 77% was enrolled in Medicaid. Limited English proficiency, Black race, lack of U.S. citizenship, and residence in a state that used an enrollment process and/or eligibility criteria distinct from the SSI program were associated with uninsurance. As states streamline Medicaid enrollment processes to meet requirements of the Affordable Care Act, they should consider the needs of this vulnerable population.
doi:10.1353/hpu.2012.0197
PMCID: PMC3671490  PMID: 23698677
Medicaid; disability; uninsured
19.  Characteristics of Adults With Substance Use Disorders Expected to Be Eligible for Medicaid Under the ACA 
Objectives
Provisions in the Affordable Care Act (ACA) are likely to expand access to substance use disorder treatment for low-income individuals. The aim of the study was to provide information on the need for substance use disorder treatment among individuals who may be eligible for Medicaid under the ACA.
Methods
The 2008 and 2009 National Survey on Drug Use and Health provided data on demographic characteristics, health status, and substance use disorders for comparison of current low-income Medicaid enrollees (N=3,809) with currently uninsured individuals with household incomes that may qualify them for Medicaid coverage beginning in 2014 (N=5,049). The incomes of the groups compared were 138% of the federal poverty level (133% provided in the ACA plus a 5% income “disregard” allowed by the law).
Results
The rate of substance use disorders among currently uninsured income-eligible individuals was slightly higher than the rate among current Medicaid enrollees (14.6% versus 11.5%, p=.03). Although both groups had significant unmet need for substance use disorder treatment, the treatment rate among those who needed treatment was significantly lower in the income-eligible group than in the currently enrolled group (31.3% versus 46.8%, p<.01). When the analysis excluded informal care received outside the medical sector, treatment rates among those with treatment needs were much lower in both groups (12.8% in the income-eligible group and 30.7% among current enrollees).
Conclusions
Findings suggest that Medicaid insurance expansions under the ACA will reduce unmet need for substance use disorder treatment.
doi:10.1176/appi.ps.201200011
PMCID: PMC3672321  PMID: 23450343
20.  IMPACT OF FDA DRUG RISK COMMUNICATIONS ON HEALTH CARE UTILIZATION AND HEALTH BEHAVIORS: A SYSTEMATIC REVIEW 
Medical Care  2012;50(6):466-478.
Objective
To review literature on the impact of FDA drug risk communications on medication utilization, health care services use, and health outcomes.
Data Sources
The authors searched MEDLINE and the Web of Science for manuscripts published between January 1990 and November 2010 that included terms related to drug utilization, the FDA, and advisories or warnings. We manually searched bibliographies and works citing selected articles and consulted with experts to guide study selection.
Study Selection
Studies were included if they involved an empirical analysis evaluating the impact of an FDA risk communication.
Data Extraction
We extracted the drug(s) analyzed, relevant FDA communication(s), data source, analytical method, and main outcome(s) assessed.
Results
Of the 1432 records screened, 49 studies were included. These studies covered sixteen medicines or therapeutic classes; one-third examined communications regarding antidepressants. Most used medical or pharmacy claims and few rigorously examined patient-provider communication, decision-making or risk perceptions. Advisories recommending increased clinical or laboratory monitoring generally led to decreased drug use, but only transient and modestly increased monitoring. Communications targeting specific subpopulations often spilled over to other groups. Repeated or sequential advisories tended to have larger but delayed effects and decreased incident more than prevalent use. Drug-specific warnings were associated with particularly large decreases in utilization, though the magnitude of substitution within therapeutic classes varied across clinical contexts.
Conclusions
While some FDA drug risk communications had immediate, strong impacts, many had either delayed or no impact on health care utilization or health behaviors. These data demonstrate the complexity of using risk communication to improve the quality and safety of prescription drug use, and suggest the importance of continued assessments of the effect of future advisories and label changes. Identifying factors that are associated with rapid and sustained responses to risk communications will be important for informing future risk communication efforts.
doi:10.1097/MLR.0b013e318245a160
PMCID: PMC3342472  PMID: 22266704
21.  Beneficiaries with cardiovascular disease and the Part D coverage gap 
Background
Medicare Part D improved access to cardiovascular medications. Increased cardiovascular drug utilization and resulting health improvements could be derailed when beneficiaries enter the coverage gap and must pay 100% of drug costs. The coverage gap remains the subject of Congressional debate; evidence regarding its impact on cardiovascular drug use and health outcomes is needed.
Methods and Results
We followed 122,255 Medicare beneficiaries with cardiovascular conditions with linked prescription and medical claims who reached the coverage gap spending threshold in 2006 or 2007. Beneficiaries entered the study upon reaching the threshold and were followed until an event, the catastrophic coverage spending threshold, or year’s end. We matched 3,980 beneficiaries who reached the threshold and received no financial assistance (exposed) to 3,980 with financial assistance during the gap period (unexposed) using propensity score (PS) and high-dimensional PS (hdPS) approaches. We compared rates of cardiovascular drug discontinuation, drug switching, and death or hospitalization for acute coronary syndrome+revascularization (ACS), congestive heart failure, or atrial fibrillation. In PS-matched analyses, exposed beneficiaries were more likely to discontinue (HR=1.57; 95% CI, 1.39–1.79, RD=13.76; 95% CI, 10.99-16.54 drugs/100 person-years) but no more or less likely to switch cardiovascular drugs. There were no significant differences in rates of death (PS-matched HR=1.23; 0.89-1.71) or other outcomes.
Conclusions
Part D beneficiaries with cardiovascular conditions with no financial assistance during the coverage gap were at increased risk for cardiovascular drug discontinuation. However, the impact of this difference on health outcomes is not clear.
doi:10.1161/CIRCOUTCOMES.111.964866
PMCID: PMC3361758  PMID: 22511746
epidemiology; Part D coverage gap; cardiovascular drugs; cardiovascular morbidity and mortality
22.  End-of-life discussions among patients with advanced cancer: A cohort study 
Annals of internal medicine  2012;156(3):204-210.
Background
National guidelines recommend that physicians discuss end-of-life (EOL) care planning with cancer patients whose life expectancy is less than one year.
Objective
To evaluate the incidence of EOL discussions for patients with stage IV lung or colorectal cancer, and where, when, and with whom discussions take place.
Design
Prospective cohort study of patients diagnosed with lung or colorectal cancer from 2003 to 2005.
Setting
Subjects lived in Northern California, Los Angeles County, North Carolina, Iowa, or Alabama, or received care in one of five large health maintenance organizations or one of fifteen Veteran’s Health Administration sites.
Patients
2155 patients with stage IV lung or colorectal cancer.
Measurements
EOL discussions reported in patient and surrogate interviews or documented in medical records through 15 months after diagnosis.
Results
73% of patients had EOL discussions identified by at least one source. Among patients who died during follow-up (N=1470), 87% had EOL discussions, versus 41% of patients who were alive at the end of follow-up (N=685). Among first EOL discussions documented in records (N=1081), 55% occurred in the hospital. Oncologists documented EOL discussions with only 27% of their patients. Among patients with documented EOL discussions who died during follow-up (N=959), discussions took place a median of 33 days before death.
Limitations
The depth and quality of EOL discussions was not evaluated. Much of the information about discussions came from surrogates of patients who died before baseline interviews could be obtained.
Conclusions
Although most patients with stage IV lung or colorectal cancer have discussions with physicians about EOL care planning before death, many discussions occur during acute hospital care, with non-oncology providers, and late in the course of illness.
doi:10.1059/0003-4819-156-3-201202070-00008
PMCID: PMC3616320  PMID: 22312140
23.  A Prescription for Drug Formulary Evaluation: An Application of Price Indexes 
Forum for health economics & policy  2012;15(2):1558-9544.1296.
Existing economic approaches to the design and evaluation of health insurance do not readily apply to coverage decisions in the multi-tiered drug formularies characterizing drug coverage in private health insurance and Medicare. This paper proposes a method for evaluating a change in the value of a formulary to covered members based on the economic theory of price indexes. A formulary is cast as a set of demand-side prices, and our measure approximates the compensation (positive or negative) that would need to be paid to consumers to accept the new set of prices. The measure also incorporates any effect of the formulary change on plan drug acquisition costs and “offset effects” on non-drug services covered by the plan. Data needed to calculate formulary value are known or can be forecast by a health plan. We illustrate the method with data from a move from a two- to a three-tier formulary.
doi:10.1515/1558-9544.1296
PMCID: PMC3556729  PMID: 23372543
24.  TRENDS IN ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) AMBULATORY DIAGNOSIS AND MEDICAL TREATMENT IN THE UNITED STATES, 2000-2010 
Academic Pediatrics  2012;12(2):110-116.
Objectives
Because of several recent clinical and regulatory changes regarding Attention Deficit Hyperactivity Disorder (ADHD) in the United States, we quantified changes in ADHD diagnosis and medication management from 2000 through 2010.
Methods
We used the IMS Health National Disease and Therapeutic Index™, a nationally representative audit of office-based providers, to examine aggregate trends among children and adolescents under 18. We also quantified how diagnosis and treatment patterns have evolved based on patient and physician characteristics and the therapeutic classes used.
Results
From 2000 to 2010, the number of physician outpatient visits where ADHD was diagnosed increased 66% from 6.2 million [M] (95% confidence intervals [CI] 5.5- 6.9M) to 10.4M visits (CI 9.3-11.6M). Of these visits, psychostimulants have remained the dominant treatment, used in 96% of treatment visits in 2000 and 87% of treatment visits in 2010. Atomoxetine use declined from 15% of treatment visits upon product launch in 2003 to 6% of treatment visits by 2010. The use of potential substitute therapies – clonidine, guanfacine, and bupropion – remained relatively constant (between 5-9% of treatment visits) during most of the period examined. Over this period, the ADHD management shifted towards psychiatrists (from 24% to 36% of all visits) without large changes in illness severity or the proportion of ADHD treatment visits accounted for by males (73%-77%).
Conclusions
In ten years, the ambulatory diagnosis of ADHD increased by two-thirds and is increasingly managed by psychiatrists. The effects of these changing treatment patterns on children's health outcomes and their families are unknown.
doi:10.1016/j.acap.2012.01.003
PMCID: PMC3307907  PMID: 22326727
Attention deficit and hyperactivity disorder; pediatrics; pediatric workforce; mental health
25.  Use of Prescription Drug Samples and Patient Assistance Programs, and the Role of Doctor–Patient Communication 
Journal of General Internal Medicine  2011;26(12):1458-1464.
BACKGROUND
Cost-related underuse of medications is common among older adults, who seldom discuss medication costs with their physicians. Some older adults may use free drug samples or industry-sponsored patient assistance programs (PAP) in hopes of lowering out-of-pocket costs, although the long-term effect of these programs on drug spending is unclear.
OBJECTIVE
To examine older adults’ use of industry-sponsored strategies to reduce out-of-pocket drug costs and the association between doctor–patient communication and use of these programs.
DESIGN
Cross-sectional analysis of a 2006 nationally representative survey of Medicare beneficiaries.
PARTICIPANTS
14,322 community-dwelling Medicare beneficiaries age ≥65.
MAIN MEASURES
We conducted bivariate and multivariate analyses of the association between receipt of free samples and participation in PAPs with sociodemographic characteristics, health status, access to care, drug coverage, medication cost burden, and doctor–patient communication.
KEY RESULTS
51.4% of seniors reported receiving at least one free sample over the last 12 months and 29.2% reported receiving free samples more than once. In contrast, only 1.3% of seniors reported participating in an industry-sponsored PAP. Higher income respondents were more likely to report free sample receipt than low-income respondents (50.8% vs. 43.8%, p < 0.001) and less likely to report participating in a PAP (0.42% vs. 2.2%, p < 0.001). In multivariate analyses, those who reported talking to their doctor about the cost of their medications had more than twice the odds of receiving samples as those who did not (OR 2.17, 95% CI 1.95–2.42).
CONCLUSIONS
In 2006, over half of seniors in Medicare received free samples, but only 1.3% reported receiving any medications from a patient assistance program. Doctor–patient communication is strongly associated with use of these programs, which has important implications for clinical care regardless of whether these programs are viewed as drivers of prescription costs or a remedy for them.
doi:10.1007/s11606-011-1801-y
PMCID: PMC3235606  PMID: 21751052
free drug samples; prescription assistance programs; Medicare; physician–patient communication

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