Entering and Exiting the Medicare Part D Coverage Gap: Role of Comorbidities and Demographics

BACKGROUND

Some Medicare Part D enrollees whose drug expenditures exceed a threshold enter a coverage gap with full cost-sharing, increasing their risk for reduced adherence and adverse outcomes.

OBJECTIVE

To examine comorbidities and demographic characteristics associated with gap entry and exit.

DESIGN

We linked 2005–2006 pharmacy, outpatient, and inpatient claims to enrollment and Census data. We used logistic regression to estimate associations of 2006 gap entry and exit with 2005 medical comorbidities, demographics, and Census block characteristics. We expressed all results as predicted percentages.

PATIENTS

287,713 patients without gap coverage, continuously enrolled in a Medicare Advantage Part D (MAPD) plan serving eight states. Patients who received a low-income subsidy, could not be geocoded, or had no 2006 drug fills were excluded.

RESULTS

Of enrollees, 15.9% entered the gap, 2.6% within the first 180 days; among gap enterers, only 6.7% exited again. Gap entry was significantly associated with female gender and all comorbidities, particularly dementia (39.5% gap entry rate) and diabetes (28.0%). Among dementia patients entering the gap, anti-dementia drugs (donepezil, memantine, rivastigmine, and galantamine) and atypical antipsychotic medications (risperidone, quetiapine, and olanzapine) together accounted for 40% of pre-gap expenditures. Among diabetic patients, rosiglitazone accounted for 7.2% of pre-gap expenditures. Having dementia was associated with twice the risk of gap exit.

CONCLUSIONS

Certain chronically ill MAPD enrollees are at high risk of gap entry and exposure to unsubsidized medication costs. Clinically vulnerable populations should be counseled on how to best manage costs through drug substitution or discontinuation of specific, non-essential medications.     

Cost-Effectiveness of Long-Term Outpatient Buprenorphine-Naloxone Treatment for Opioid Dependence in Primary Care

BACKGROUND

Primary care physicians with appropriate training may prescribe buprenorphine-naloxone (bup/nx) to treat opioid dependence in US office-based settings, where many patients prefer to be treated. Bup/nx is off patent but not available as a generic.

OBJECTIVE

We evaluated the cost-effectiveness of long-term office-based bup/nx treatment for clinically stable opioid-dependent patients compared to no treatment.

DESIGN, SUBJECTS, AND INTERVENTION

A decision analytic model simulated a hypothetical cohort of clinically stable opioid-dependent individuals who have already completed 6 months of office-based bup/nx treatment. Data were from a published cohort study that collected treatment retention, opioid use, and costs for this population, and published quality-of-life weights. Uncertainties in estimated monthly costs and quality-of-life weights were evaluated in probabilistic sensitivity analyses, and the economic value of additional research to reduce these uncertainties was also evaluated.

MAIN MEASURES

Bup/nx, provider, and patient costs in 2010 US dollars, quality-adjusted life years (QALYs), and incremental cost-effectiveness (CE) ratios ($/QALY); costs and QALYs are discounted at 3% annually.

KEY RESULTS

In the base case, office-based bup/nx for clinically stable patients has a CE ratio of $35,100/QALY compared to no treatment after 24?months, with 64% probability of being < $100,000/QALY in probabilistic sensitivity analysis. With a 50% bup/nx price reduction the CE ratio is $23,000/QALY with 69% probability of being < $100,000/QALY. Alternative quality-of-life weights result in CE ratios of $138,000/QALY and $90,600/QALY. The value of research to reduce quality-of-life uncertainties for 24-month results is $6,400 per person eligible for treatment at the current bup/nx price and $5,100 per person with a 50% bup/nx price reduction.

CONCLUSIONS

Office-based bup/nx for clinically stable patients may be a cost-effective alternative to no treatment at a threshold of $100,000/QALY depending on assumptions about quality-of-life weights. Additional research about quality-of-life benefits and broader health system and societal cost savings of bup/nx therapy is needed.     

Out-of-Pocket Spending in the Last Five Years of Life

BACKGROUND

A key objective of the Medicare program is to reduce risk of financial catastrophe due to out-of-pocket healthcare expenditures. Yet little is known about cumulative financial risks arising from out-of-pocket healthcare expenditures faced by older adults, particularly near the end of life.

DESIGN

Using the nationally representative Health and Retirement Study (HRS) cohort, we conducted retrospective analyses of Medicare beneficiaries’ total out-of-pocket healthcare expenditures over the last 5 years of life.

PARTICIPANTS

We identified HRS decedents between 2002 and 2008; defined a 5 year study period using each subject’s date of death; and excluded those without Medicare coverage at the beginning of this period (n?=?3,209).

MAIN MEASURES

We examined total out-of-pocket healthcare expenditures in the last 5 years of life and expenditures as a percentage of baseline household assets. We then stratified results by marital status and cause of death. All measurements were adjusted for inflation to 2008 US dollars.

RESULTS

Average out-of-pocket expenditures in the 5 years prior to death were $38,688 (95 % Confidence Interval $36,868, $40,508) for individuals, and $51,030 (95 % CI $47,649, $54,412) for couples in which one spouse dies. Spending was highly skewed, with the median and 90th percentile equal to $22,885 and $89,106, respectively, for individuals, and $39,759 and $94,823, respectively, for couples. Overall, 25 % of subjects’ expenditures exceeded baseline total household assets, and 43 % of subjects’ spending surpassed their non-housing assets. Among those survived by a spouse, 10 % exceeded total baseline assets and 24 % exceeded non-housing assets. By cause of death, average spending ranged from $31,069 for gastrointestinal disease to $66,155 for Alzheimer’s disease.

CONCLUSION

Despite Medicare coverage, elderly households face considerable financial risk from out-of-pocket healthcare expenses at the end of life. Disease-related differences in this risk complicate efforts to anticipate or plan for health-related expenditures in the last 5 years of life.     

Is Implementation of the Care Transitions Intervention Associated with Cost Avoidance After Hospital Discharge?

BACKGROUND

Poorly-executed transitions out of the hospital contribute significant costs to the healthcare system. Several evidence-based interventions can reduce post-discharge utilization.

OBJECTIVE

To evaluate the cost avoidance associated with implementation of the Care Transitions Intervention (CTI).

DESIGN

A quasi-experimental cohort study using consecutive convenience sampling.

PATIENTS

Fee-for-service Medicare beneficiaries hospitalized from 1 January 2009 to 31 May 2011 in six Rhode Island hospitals.

INTERVENTION

The CTI is a patient-centered coaching intervention to empower individuals to better manage their health. It begins in-hospital and continues for 30 days, including one home visit and one to two phone calls.

MAIN MEASURES

We examined post-discharge total utilization and costs for patients who received coaching (intervention group), who declined or were lost to follow-up (internal control group), and who were eligible, but not approached (external control group), using propensity score matching to control for baseline differences.

KEY RESULTS

Compared to matched internal controls (N?=?321), the intervention group had significantly lower utilization in the 6 months after discharge and lower mean total health care costs ($14,729 vs. $18,779, P?=?0.03). The cost avoided per patient receiving the intervention was $3,752, compared to internal controls. Results for the external control group were similar. Shifting of costs to other utilization types was not observed.

CONCLUSIONS

This analysis demonstrates that the CTI generates meaningful cost avoidance for at least 6 months post-hospitalization, and also provides useful metrics to evaluate the impact and cost avoidance of hospital readmission reduction programs.     

Medical Expenditures Among Medicare Beneficiaries with Statin-Associated Adverse Effects Following Myocardial Infarction

Purpose

Compare medical expenditures among adults with statin-associated adverse effects (SAAE) and high statin adherence (HSA) following myocardial infarction (MI).

Methods

We analyzed expenditures in 2016 US dollars among Medicare beneficiaries with SAAE (n?=?1741) and HSA (n?=?55,567) who were ≥?66 years of age and initiated moderate/high-intensity statins following an MI in 2007–2013. SAAE were identified through a claims-based algorithm, which included down-titrating statins and initiating ezetimibe, switching to ezetimibe monotherapy, having a rhabdomyolysis or antihyperlipidemic adverse event followed by statin down-titration or discontinuation, or switching between ≥?3 statin types within 365 days following MI. HSA was defined by having a statin available to take for ≥?80% of the days in the 365 days following MI.

Results

Expenditures among beneficiaries with SAAE and HSA were $40,776 (95% CI $38,329–$43,223) and $26,728 ($26,482–$26,974), respectively, in the 365 days following MI, and $34,238 ($31,396–$37,080) and $29,053 ($28,605–$29,500), respectively, for every year after the first 365 days. Multivariable-adjusted ratios comparing expenditures among beneficiaries with SAAE versus HSA in the first 365 days and after the first 365 days following MI were 1.51 (95% CI 1.43–1.59) and 1.23 (1.12–1.34), respectively. Inpatient and outpatient expenditures were higher among beneficiaries with SAAE versus HSA during and after the first 365 days following MI. Compared to beneficiaries with HSA, medication expenditures among those with SAAE were similar in the 365 days following MI, but higher afterwards. Other medical expenditures were higher among beneficiaries with SAAE versus HSA.

Conclusion

SAAE are associated with increased expenditures following MI compared with HSA.

     

Generic Atorvastatin, the Belgian Statin Market and the Cost-Effectiveness of Statin Therapy

Purpose

This study examines how the market entry of generic atorvastatin influences the Belgian statin market and the cost-effectiveness of statin therapy.

Methods

Using IMS Health data, the Belgian 2000–2011 statin market was analyzed in terms of total expenditure, annual price of statin treatment, and patient numbers. A simulation analysis projected statin market shares from 2012 to 2015 following market entry of generic atorvastatin. This analysis was based on three scenarios regarding the number of patients taking specific statins. Savings associated with an atorvastatin price reduction of 50–70 % were calculated. A literature review of economic evaluations assessed the cost-effectiveness of generic atorvastatin.

Results

Statin expenditure increased from €113 million in 2000 to €285 million in 2011 due to higher expenditure on atorvastatin and rosuvastatin. Although the number of patients treated with simvastatin increased by nearly 800 %, the resulting increase in expenditure was partially offset by price reductions. Atorvastatin is projected to become the dominant product in the Belgian statin market (market share of 47–66 % by 2015). Annual savings would attain €108.6–€153.7 million for a 50 % reduction in the atorvastatin price and €152.0–€215.2 million for a 70 % price reduction. The literature suggests that generic atorvastatin is cost-effective as compared to simvastatin. The limited evidence about the cost-effectiveness of rosuvastatin as compared with generic atorvastatin is inconclusive.

Conclusions

Generic atorvastatin is cost-effective as compared to simvastatin, is projected to become the dominant product in the Belgian statin market and is expected to generate substantial savings to health care payers.     

The HIV-specific advance directive

Objective

To determine whether persons living with HIV find a disease-specific advance directive more acceptable than a generic directive.

Design

Randomized clinical trial.

Setting

HIV consumer organization and hospital-based HIV clinic.

Participants

Volunteer sample of persons with HIV.

Interventions

The disease-specific HIV Living Will, the generic Centre for Bioethics Living Will, or both.

Measurements and main results

Of 101 participants who received both advance directives, 78 (77.2%) preferred the disease-specific HIV Living Will and 23 (22.8%) preferred the generic Centre for Bioethics Living Will (p<.001). Most participants who preferred the HIV Living Will did so because it was more specific or relevant to their situation.

Conclusions

Persons living with HIV prefer a disease-specific to a generic advance directive. They should be offered a disease-specific advance directive. Our findings should also encourage investigators to develop and evaluate disease-specific advance directives in other clinical settings.     

Use of Chronic Care Management Codes for Medicare Beneficiaries: a Missed Opportunity?

Background

Physicians spend significant time outside of regular office visits caring for complex patients, and this work is often uncompensated. In 2015, the Centers for Medicare & Medicaid Services (CMS) introduced a billing code for care coordination between office visits for beneficiaries with multiple chronic conditions.

Objective

Characterize use of the Chronic Care Management (CCM) code in New England in 2015.

Design

Retrospective observational analysis.

Participants

All Medicare fee-for-service beneficiaries in New England continuously enrolled in Parts A and B in 2015.

Intervention

None.

Main measures

The primary outcome was the number of beneficiaries with a CCM claim per 1000 eligible beneficiaries. Secondary outcomes included the total number of CCM claims, total reimbursement, mean number of claims per beneficiary, and beneficiary characteristics independently associated with receiving CCM services.

Key results

Of the more than two million Medicare fee-for-service beneficiaries in New England, almost 1.7 million were potentially eligible for CCM services. Among eligible beneficiaries, 10,951 (0.65%) had a CCM claim in 2015. Massachusetts had the highest penetration of CCM use (9.40 claims per 1000 eligible beneficiaries); Vermont had the lowest (0.54 claims per 1000 eligible beneficiaries). Mean reimbursement per physician was $1745.98. Age, race/ethnicity, dual-eligible status, income, number of chronic conditions, and state of residence were associated with receiving CCM services in an adjusted model.

Conclusions

The CCM code is likely underutilized in New England; the program may therefore not be achieving its intended goal of encouraging consistent, team-based chronic care management for Medicare’s most complex beneficiaries. Or practices may be foregoing reimbursement for care coordination that they are already providing. Recently implemented revisions may improve uptake of CCM services; it will be important to compare our results with future utilization.

     

Impact of medicare part D on access to and cost sharing for specialty biologic medications for beneficiaries with rheumatoid arthritis

Objective

Many worry that the use of specialty tiering for biologic disease‐modifying antirheumatic drugs (DMARDs) by Medicare Part D plans imposes a heavy financial burden on beneficiaries with rheumatoid arthritis (RA). To date, no one has examined the cost‐sharing structures for biologic DMARDs in Part D plans or the resulting cost burden for patients.

Methods

We followed 14,929 vulnerable, low‐income patients with RA who were enrolled in the Medicare Replacement Drug Demonstration (MRDD) in 2005. As the MRDD population transitioned into Part D in 2006, we examined correlates of Part D enrollment and compared the cost‐sharing provisions for biologic DMARDs in the Medicare Advantage and stand‐alone plans. We simulated the out‐of‐pocket costs of beneficiaries under 3 cost‐sharing scenarios.

Results

Eighty‐one percent of MRDD beneficiaries with RA enrolled in Part D. Enrollment predictors were female sex (odds ratio [OR] 1.48, 95% confidence interval [95% CI] 1.32–1.67), prior MRDD benefit use (OR 2.29, 95% CI 2.04–2.58), other self‐reported drug coverage (OR 1.53, 95% CI 1.36–1.71), and receiving an MRDD subsidy (OR 2.00, 95% CI 1.74–2.30). Compared with stand‐alone plans, Medicare Advantage plans had lower deductibles, lower premiums, and fewer prior authorization, step therapy, and quantity limit restrictions. However, ～75% of all plans used coinsurance as the preferred form of cost sharing. Out‐of‐pocket costs exceeded $4,000 annually in all cost‐sharing scenarios.

Conclusion

Most MRDD beneficiaries with RA enrolled in Part D. Although plans assume some costs for biologic DMARDs, the majority of costs are shifted to beneficiaries and to Medicare. Such cost shifting may place these medications out of the beneficiary's financial reach and expose Medicare to high financial liability.     

Patient perspectives on de‐simplifying their single‐tablet co‐formulated antiretroviral therapy for societal cost savings

Objectives

The incremental costs of expanding antiretroviral (ARV) drug treatment to all HIV‐infected patients are substantial, so cost‐saving initiatives are important. Our objectives were to determine the acceptability and financial impact of de‐simplifying (i.e. switching) more expensive single‐tablet formulations (STFs) to less expensive generic‐based multi‐tablet components. We determined physician and patient perceptions and acceptance of STF de‐simplification within the context of a publicly funded ARV budget.

Methods

Programme costs were calculated for patients on ARVs followed at the Southern Alberta Clinic, Canada during 2016 (Cdn$). We focused on patients receiving Triumeq® and determined the savings if patients de‐simplified to eligible generic co‐formulations. We surveyed all prescribing physicians and a convenience sample of patients taking Triumeq® to see if, for budgetary purposes, they felt that de‐simplification would be acceptable.

Results

Of 1780 patients receiving ARVs, 62% (n = 1038) were on STF; 58% (n = 607) of patients on STF were on Triumeq®. The total annual cost of ARVs was $26 222 760. The cost for Triumeq® was $8 292 600. If every patient on Triumeq® switched to generic abacavir/lamivudine and Tivicay® (dolutegravir), total costs would decrease by $4 325 040. All physicians (n = 13) felt that de‐simplifying could be safely achieved. Forty‐eight per cent of 221 patients surveyed were agreeable to de‐simplifying for altruistic reasons, 27% said no, and 25% said maybe.

Conclusions

De‐simplifying Triumeq® generates large cost savings. Additional savings could be achieved by de‐simplifying other STFs. Both physicians and patients agreed that selective de‐simplification was acceptable; however, it may not be acceptable to every patient. Monitoring the medical and cost impacts of de‐simplification strategies seems warranted.

     

Variation in Specialty Outpatient Care Patterns in the Medicare Population

Background

Multiple payment reform efforts are under way to improve the value of care delivered to Medicare beneficiaries, yet few directly address the interface between primary and specialty care.

Objective

To describe regional variation in outpatient visits for individual specialties and the association between specialty physician-specific payments and patient-reported satisfaction with care and health status.

Design

Retrospective cross-sectional study.

Patients

A 20 % random sample of Medicare fee-for-service beneficiaries in 2012.

Main Measures

Regions were grouped into quartiles of specialist index, defined as the observed/expected regional likelihood of having an outpatient visit to a specialist, for ten common specialties, adjusting for age, sex, and race. Outcomes were per capita specialty-specific physician payments and Medicare Current Beneficiary Survey responses.

Key Results

The proportion of beneficiaries seeing a specialist varied the most for endocrinology and gastroenterology (3.7- and 3.9-fold difference between the highest and lowest quartiles, respectively) and least for orthopedics and urology (1.5- and 1.7-fold difference, respectively). Multiple analyses suggested that this variation was not explained by prevalence of disease. Average specialty-specific payments were strongly associated with the likelihood of visiting a specialist. Differences in per capita payments from lowest (Q1) to highest quartiles (Q4) were greatest for cardiology ($89, $135, $172, $251) and dermatology ($46, $64, $82, $124). Satisfaction with overall care (median [interquartile range] across specialties: Q1, 93.3 % [92.6–93.7 %]; Q4, 93.1 % [92.9–93.2 %]) and self-reported health status (Q1, 37.1 % [36.9–37.7 %]; Q4, 38.2 % [37.2–38.4 %]) was similar across quartiles. Satisfaction with access to specialty care was consistently lower in the lowest quartile of specialty index (Q1, 89.7 % [89.2–91.1 %]; Q4, 94.5 % [94.4–94.8 %]).

Conclusions

Substantial regional variability in outpatient specialist visits is associated with greater payments with limited benefits in terms of patient-reported satisfaction with care or reported health status. Reducing outpatient physician visits may represent an important opportunity to improve the efficiency of care.

     

Quality of Care and Racial Disparities in Medicare Among Potential ACOs

BACKGROUND

The Medicare Accountable Care Organization (ACO) programs encourage integration of providers into large groups and reward provider groups for improving quality, but not explicitly for reducing health care disparities. Larger group size and better overall quality may or may not be associated with smaller disparities.

OBJECTIVE

To examine differences in patient characteristics between provider groups sufficiently large to participate in ACO programs and smaller groups; the association between group size and racial disparities in quality; and the association between quality and disparities among larger groups.

DESIGN AND PARTICIPANTS

Using 2009 Medicare claims for 3.1 million beneficiaries with cardiovascular disease or diabetes and linked data on provider groups, we compared racial differences in quality by provider group size, adjusting for patient characteristics. Among larger groups, we used multilevel models to estimate correlations between group performance on quality measures for white beneficiaries and black–white disparities within groups.

MAIN MEASURES

Four process measures of quality, hospitalization for ambulatory care-sensitive conditions (ACSCs) related to cardiovascular disease or diabetes, and hospitalization for any ACSC.

KEY RESULTS

Beneficiaries served by larger groups were more likely to be white and live in areas with less poverty and more education. Larger group size was associated with smaller disparities in low-density lipoprotein (LDL) cholesterol testing and retinal exams, but not in other process measures or hospitalization for ACSCs. Among larger groups, better quality for white beneficiaries in one measure (hospitalization for ACSCs related to cardiovascular disease or diabetes) was correlated with smaller racial disparities (r?=?0.28; P?=?0.02), but quality was not correlated with disparities in other measures.

CONCLUSIONS

Larger provider group size and better performance on quality measures were not consistently associated with smaller racial disparities in care for Medicare beneficiaries with cardiovascular disease or diabetes. ACO incentives rewarding better quality for minority groups and payment arrangements supporting ACO development in disadvantaged communities may be required for ACOs to promote greater equity in care.