Utilization Management Trends in Medicare Part D Oncology Drugs, 2010-2020.

This study examines the exposure of Medicare Part D beneficiaries to utilization management, such as prior authorization, for oral oncology drugs.

Prescription Drug Spending in Fee-for-Service Medicare, 2008-2019.

Importance: Prescription drug spending is a topic of increased interest to the public and policymakers. However, prior assessments have been limited by focusing on retail spending (Part D-covered drugs), omitting clinician-administered (Part B-covered) drug spending, or focusing on all fee-for-service Medicare beneficiaries, regardless of their enrollment into prescription drug coverage. Objective: To estimate the proportion of health care spending contributed by prescription drugs and to assess spending for retail and clinician-administered prescriptions. Design, Setting, and Participants: Descriptive, serial, cross-sectional analysis of a 20% random sample of fee-for-service Medicare beneficiaries in the United States from 2008 to 2019 who were continuously enrolled in Parts A (hospital), B (medical), and D (prescription drug) benefits, and not in Medicare Advantage. Exposure: Calendar year. Main Outcomes and Measures: Net spending on retail (Part D-covered) and clinician-administered (Part B-covered) prescription drugs; prescription drug spending (spending on Part B-covered and Part D-covered drugs) as a percentage of total per-capita health care spending. Measures were adjusted for inflation and for postsale rebates (for Part D-covered drugs). Results: There were 3 201 284 beneficiaries enrolled in Parts A, B, and D in 2008 and 4 502 718 in 2019. In 2019, beneficiaries had a mean (SD) age of 71.7 (12.0) years, documented sex was female for 57.7%, and 69.5% had no low-income subsidies. Total per-capita spending was $16 345 in 2008 and $20 117 in 2019. Comparing 2008 with 2019, per-capita Part A spending was $7106 (95% CI, $7084-$7128) vs $7120 (95% CI, $7098-$7141), Part B drug spending was $720 (95% CI, $713-$728) vs $1641 (95% CI, $1629-$1653), Part B nondrug spending was $5113 (95% CI, $5105-$5122) vs $6702 (95% CI, $6692-$6712), and Part D net spending was $3122 (95% CI, $3117-$3127) vs $3477 (95% CI, $3466-$3489). The proportion of total annual spending attributed to prescription drugs increased from 24.0% in 2008 to 27.2% in 2019, net of estimated rebates and discounts. Conclusions and Relevance: In 2019, spending on prescription drugs represented approximately 27% of total spending among fee-for-service Medicare beneficiaries enrolled in Part D, even after accounting for postsale rebates.

Opioid Prescriptions by Pain Medicine Physicians in the Medicare Part D Program: A Cross-Sectional Study.

BACKGROUND: Pain medicine physicians (PMP) are a group of physicians with background training in various primary specialties with interest and expertise in managing chronic pain disorders. Our objective is to analyze prescription drug (PD) claims from the Medicare Part D program associated with PMP to gain insights into patterns, associated costs, and potential cost savings areas. METHODS: The primary data source for Part D claims data is the Centers for Medicare and Medicaid Services (CMS) Chronic Conditions Data Warehouse, which contains Medicare Part D prescription drug events (PDE) records received through the claims submission cutoff date. Only providers with taxonomies of pain management (PM) and interventional pain management (IPM) were included in the study. The analysis of PDE was restricted to drugs with >250 claims. The distribution of claims and costs were analyzed based on drug class and provider specialty. Subsequently, we explored claims and expenses for opioid drug prescriptions in detail. Prescribing characteristics of the top 5% of providers by costs and claims were examined to gain additional insights. The costs and claims were explored for the top 10 drugs prescribed by PMP in 2017. RESULTS: There were a total of unique 3280 PMP-prescribed drugs with an associated expense of 652 million dollars in the 2017 Medicare Part D program. Prescriptions related to PMP account for a tiny fraction of the program's drug expenditure (0.4%). Opioids, anticonvulsants, and gabapentinoids were associated with the largest number of claims and the largest expenses within this fraction. Among opioid drug prescriptions, brand-named drugs account for a small fraction of claims (8%) compared to generic drugs. However, the expenses associated with brand name drugs were higher than generic drugs. Prescribers in the top 5% by PD costs had a higher number of claims, prescribed a higher proportion of branded medications, and had prescriptions associated with longer day supply compared to an average PMP. There were several opioid medications in the top 10 PD list by cost associated with PMP. CONCLUSIONS: Opioids were the most common medications among Medicare part D claims prescribed by PMP. Only 12% of the total opioid PD claims were by PMP. The top 5% of PMP prescribers had 10 times more claims than the average PMP.

Moving Pharmacy Benefits from Nice to Have to Essential Benefits.

DISCLOSURES: No funding supported the writing of this commentary. The authors have nothing to disclose.

The impact of Medicare Part D on opioid use among U.S. older adults.

BACKGROUND: To assess the association between the implementation of Medicare Part D and the use of outpatient prescription opioids. METHODS: Nationally representative data on community-dwelling adults aged 60-69 came from the 2000-2015 Medical Expenditure Panel Survey (MEPS) (N = 26,545). A difference-in-differences approach was used to compare opioid use between Medicare eligible (ages 66-69) and Medicare ineligible (ages 60-64) adults before and after the introduction of Part D in 2006, while controlling for socio-demographic characteristics, risk factors for opioid use, and secular trends. RESULTS: Medicare Part D was associated with a small and statistically non-significant increase in the number of outpatient prescription opioids filled in a year (coefficient, 0.03; 95% CI, -0.08 to 0.13), in the amount of morphine milligrams equivalents (coefficient, 113.23; 95% CI, -25.47 to 251.93), and in the odds of using any prescription opioid (OR, 1.03; 95% CI, 0.85 to 1.26). There was no evidence for a heterogeneous effect of Part D across subgroups. The results were robust to the impacts of the 2007-2009 recession, the spillover effect of the Affordable Care Act, and the anticipation effect of Part D. DISCUSSION: Although policymakers suggested that gaining access to medical care as a result of insurance expansion might have fueled the opioid epidemic, this paper found limited evidence to support this claim. While Part D took effect more than a decade ago, its long-term implication for opioid use is still relevant for the recent opioid epidemic and future health insurance expansions such as the proposed Medicare-for-all initiative.

Changes in Opioid Prescribing Patterns Among Generalists and Oncologists for Medicare Part D Beneficiaries From 2013 to 2017.

Importance: In response to the opioid epidemic, policies aiming to reduce opioid prescribing, misuse, and abuse may have the unintended consequence of restricting access to necessary opioid therapy for cancer-related pain. It is unknown how opioid prescribing patterns have changed among generalists and oncologists during this era. Objective: To examine trends in opioid prescription rates for Medicare Part D beneficiaries from 2013 to 2017 among oncologists and generalists. Design, Setting, and Participants: This repeated cross-sectional study of generalist physicians (internal medicine, family medicine, geriatric medicine, general practice) and oncology specialists (medical oncology, hematology-oncology, and radiation oncology) analyzed the Medicare Provider Utilization and Payment Data: Part D prescriber files from 2013 to 2017. Exposures: Generalist vs oncology specialty. Main Outcomes and Measures: Outcomes included physician-level rates of both opioid and long-acting opioid prescriptions per 100 Medicare Part D beneficiaries. Poisson regression was used to estimate annual predicted outcome rates and incidence rate ratios, adjusting for prescriber characteristics and state fixed effects. Results: We analyzed the prescribing patterns of 251 820 generalists and 14 210 oncologists. From 2013 to 2017, the annual adjusted predicted mean rate of opioid prescriptions per 100 Medicare beneficiaries decreased from 68.2 to 49.7 among generalists (adjusted incidence rate ratio [aIRR] = 0.73; 95% CI, 0.73-0.73) and from 77.8 to 58.8 among oncologists (aIRR = 0.76; 95% CI, 0.74-0.77). The rate of long-acting opioid prescriptions per 100 Medicare beneficiaries also decreased from 8.0 to 5.4 for generalists (aIRR = 0.67; 95% CI, 0.66-0.68) and from 18.6 to 13.3 for oncologists (aIRR = 0.72; 95% CI, 0.69-0.74). Conclusions and Relevance: We found large declines in opioid prescription rates for Medicare beneficiaries by generalists and oncologists from 2013 to 2017. Opioid policy and advocacy appear to have been effective in reducing the extent of opioid prescribing in the Medicare population. Similar declines between generalists and oncologists raise concern that access to cancer pain management may have been inadvertently restricted. How much of the decrease in prescribing by oncologists is appropriate vs inappropriate deserves further investigation.

Prostaglandin Coverage and Costs to Medicare and Medicare Beneficiaries, 2009-2017.

BACKGROUND: Prostaglandin analogs are the most effective treatment for glaucoma, a common condition among older adults. Despite the availability of generic drugs, the costs associated with these prescription drugs are rising. OBJECTIVE: To characterize Medicare prescription drug plan (PDP) formulary coverage and beneficiary out-of-pocket cost for prostaglandin analogs from 2009 to 2017 and Medicare spending on prostaglandin analogs from 2013 to 2017. METHODS: This study was a retrospective analysis. We used 2009, 2013, and 2017 Medicare PDP formulary, beneficiary cost, and pricing files to determine beneficiary first-prescription out-of-pocket costs and plan coverage (unrestricted, restricted, or not covered) of branded latanoprost 0.005%, travoprost 0.004%, bimatoprost 0.03% and 0.01%, and tafluprost 0.0015% and of generic latanoprost 0.005% and generic bimatoprost 0.03%. We also used Medicare Part D spending data to determine aggregate spend in 2013 and 2017. RESULTS: In 2009, 92% of plans covered branded latanoprost, 83% covered branded bimatoprost; and 49% covered branded travoprost, whereas in 2017, 6% of plans covered branded latanoprost; 95% covered branded bimatoprost; and 96% covered branded travoprost. Although generic latanoprost was universally covered, generic bimatoprost was only covered by 35% of plans in 2017. Median out-of-pocket cost of branded prostaglandins without generic equivalents was $35 (IQR = $29-$40) in 2009, $45 (IQR = $42-$101) in 2013, and $90 (IQR = $45-$159) in 2017. Median out-of-pocket cost of all available generic prostaglandins was $10 (IQR = $5-$33) in 2013 and $10 (IQR = $4-$15) in 2017. In 2013, Medicare spent $733 million on prostaglandin analogs; in 2017, this increased to $1.09 billion, with $943 million (86%) spent on branded prostaglandins and $148 million (14%) spent on generics. CONCLUSIONS: Medicare PDP coverage of branded prostaglandins remained stable from 2009 to 2017. While median beneficiary out-of-pocket costs associated with generic prostaglandins remained stable, those associated with branded prostaglandins increased nearly 3-fold. DISCLOSURES: Research reported in this publication was supported by National Heart, Lung and Blood Institute of the National Institutes of Health under Award Number T35HL007649. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Heart, Lung, and Blood Institute or the National Institutes of Health. Shah has received research support through Mayo Clinic from the U.S. Food and Drug Administration (FDA) to establish Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938); the Centers of Medicare and Medicaid Innovation under the Transforming Clinical Practice Initiative (TCPI); the Agency for Healthcare Research and Quality (U19HS024075, R01HS025164, R01HS025402, R03HS025517); and the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R56HL130496, R01HL131535), National Science Foundation, and the Patient Centered Outcomes Research Institute to develop a clinical data research network. Ross has received research support through Yale University from Johnson & Johnson to develop methods of clinical trial data sharing; Medtronic and the FDA to develop methods for postmarket surveillance of medical devices (U01FD004585); the FDA to establish Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation program (U01FD005938); the Blue Cross Blue Shield Association to better understand medical technology evaluation; the Centers of Medicare & Medicaid Services to develop and maintain performance measures that are used for public reporting (HHSM-500-2013-13018I); the Agency for Healthcare Research and Quality (R01HS022882); the National Heart, Lung and Blood Institute of the NIH (R01HS025164); and the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International and the Collaboration on Research Integrity and Transparency at Yale. The other authors have nothing to disclose.

Identifying potential targets for prevention and treatment of amyotrophic lateral sclerosis based on a screen of medicare prescription drugs.

Background: Few well-established factors are associated with risk of amyotrophic lateral sclerosis (ALS). We comprehensively evaluate prescription drugs use in administrative health claims from U.S. Medicare beneficiaries in relation to ALS risk to generate hypotheses for further research. Methods: This is a population-based case-control study of 10,450 U.S. Medicare participants (ages 66-89 years) diagnosed with ALS, based on Medicare Parts A and B fee-for-service claims, between 1 January 2008, and 31 December 2014, and 104,500 controls (1:10 ratio) frequency-matched on age, sex, and selection year. Odds ratios (ORs) for the ALS association with 685 prescription drugs were estimated using logistic regression models for both a one- and three-year lag period. Covariates included demographic characteristics and key comorbidities, among other factors. Prescription drug use was based on Medicare Part D claims. We adjusted for multiple comparisons using a Bonferroni correction. Additional a priori analyses of sex hormone drugs were also undertaken. Results: In the large drug screen, we found 10 drugs significantly associated with lower ALS risk after the multiple-testing correction in a one-year and three-year lag analysis. These included several drugs for hypertension, diabetes, and cardiovascular disease. In a separate a priori inquiry of sex hormone drugs, tamoxifen was related to lower ALS risk, and testosterone to a higher risk in women. Conclusions: These associations warrant replication in databases that include information on the severity and duration of medical conditions underlying drug use, and drug use over a longer portion of individuals' lifespans, to further help evaluate confounding by indication.

Impact of medication synchronization programs on proportion of days covered (PDC) scores and Medicare Part D medication-related adherence metrics.

OBJECTIVES: This study aimed to determine if patients enrolled in a medication synchronization program have improvements in proportion of days covered (PDC) score for 3 of the Centers for Medicare and Medicaid Services adherence metrics medication classes: statins, renin-angiotensin-aldosterone system antagonists, and noninsulin diabetes medications. METHODS: This retrospective cohort study used data from members of a Medicare Advantage Prescription Drug plan, who took at least 1 of the key metric medications and had sufficient data to calculate a PDC score. The exposed cohort ("sync") consisted of patients who enrolled in the medication synchronization program within the plan's preferred pharmacy network, and the control group consisted of those who did not enroll in the program but met all other criteria. The primary end point was the change in PDC score from 2015 (baseline) to 2017 for each medication class. Secondary end points included the proportion of members with PDC scores of at least 85% and the association of adherence with annual medical and pharmacy costs. RESULTS: The largest PDC score increases for the entire study population were seen in all 3 sync groups (RASA, diabetes, and statin) with corresponding statistically significant PDC score increases of 1.6%, 4.8%, and 2.9%, compared with -0.4%, 0.5%, and 1.3% changes in the control groups. In the multiple linear regression analysis, there were significant PDC score differences in the changes from baseline between the sync and control RASA, diabetes, and statin groups (P = 0.005, P = 0.01, and P < 0.001, respectively). The proportion of members achieving the acceptable PDC score threshold increased by 1.1% in the control group and by 4.1% in the sync group. CONCLUSION: In a population of patients with high baseline adherence, this medication synchronization program was associated with a statistically significant increase in adherence scores for statin, RASA, and noninsulin diabetes medications. There was no significant change in medical or pharmacy costs from the health plan perspective.

Secular Trends in the Cost of Immunosuppressants after Solid Organ Transplantation in the United States.

BACKGROUND AND OBJECTIVES: Immunosuppressive medications are critical for maintenance of graft function in transplant recipients but can represent a substantial financial burden to patients and their insurance carriers. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: To determine whether availability of generic immunosuppressive medications starting in 2009 may have alleviated some of that burden, we used Medicare Part D prescription drug events between 2008 and 2013 to estimate the average annualized per-patient payments made by patients and Medicare in a large national sample of kidney, liver, and heart transplant recipients. Repeated measures linear regression was used to determine changes in payments over the study period. RESULTS: Medicare Part D payments for two commonly used immunosuppressive medications, tacrolimus and mycophenolic acid (including mycophenolate mofetil and mycophenolate sodium), decreased overall by 48%-67% across organs and drugs from 2008 to 2013, reflecting decreasing payments for brand and generic tacrolimus (21%-54%), and generic mycophenolate (72%-74%). Low-income subsidy payments, which are additional payments made under Medicare Part D, also decreased during the study period. Out-of-pocket payments by patients who did not receive the low-income subsidy decreased by more than those who did receive the low-income subsidy (63%-79% versus 24%-44%). CONCLUSIONS: The decline in payments by Medicare Part D and by transplant recipients for tacrolimus and mycophenolate between 2008 and 2013 suggests that the introduction of generic immunosuppressants during this period has resulted in substantial cost savings to Medicare and to patients, largely reflecting the transition from brand to generic products.

Coverage of Novel Therapeutic Agents by Medicare Prescription Drug Plans Following FDA Approval.

BACKGROUND: Regulatory approval of novel therapies by the FDA does not guarantee insurance coverage requisite for most clinical use. In the United States, the largest health insurance payer is the Centers for Medicare & Medicaid Services (CMS), which provides Part D prescription drug benefits to over 43 million Americans. While the FDA and CMS have implemented policies to improve the availability of novel therapies to patients, the time required to secure Medicare prescription drug benefit coverage-and accompanying restrictions-has not been previously described. OBJECTIVE: To characterize Medicare prescription drug plan coverage of novel therapeutic agents approved by the FDA between 2006 and 2012. METHODS: This is a cross-sectional study of drug coverage using Medicare Part D prescription drug benefit plan data from 2007 to 2015. Drug coverage was defined as inclusion of a drug on a plan formulary, evaluated at 1 and 3 years after FDA approval. For covered drugs, coverage was categorized as unrestrictive or restrictive, which was defined as requiring step therapy or prior authorization. Median coverage was estimated at 1 and 3 years after FDA approval, overall, and compared with a number of drug characteristics, including year of approval, CMS-protected class status, biologics versus small molecules, therapeutic area, orphan drug status, FDA priority review, and FDA-accelerated approval. RESULTS: Among 144 novel therapeutic agents approved by the FDA between 2006 and 2012, 14% (20 of 144) were biologics; 40% (57 of 144) were included in a CMS-protected class; 31% (45 of 144) were approved under an orphan drug designation; 42% (60 of 144) received priority review; and 11% (16 of 144) received accelerated approval. The proportion of novel therapeutics covered by at least 1 Medicare prescription drug plan was 90% (129 of 144) and 97% (140 of 144) at 1 year and 3 years after approval, respectively. At 3 years after approval, 28% (40 of 144) of novel therapeutics were covered by all plans. Novel therapeutic agents were covered by a median of 61% (interquartile range [IQR] = 39%-90%) of plans at 1 year and 79% (IQR = 57%-100%) at 3 years (P < 0.001). When novel therapeutics were covered, many plans restricted coverage through prior authorization or step therapy requirements. The median proportion of unrestrictive coverage was 29% (IQR = 13%-54%) at 3 years. Several drug characteristics, including therapeutic area, FDA priority review, FDA-accelerated approval, and CMS-protected drug class, were associated with higher rates of coverage, whereas year of approval, drug type, and orphan drug status were not. CONCLUSIONS: Most Medicare prescription drug plans covered the majority of novel therapeutics in the year following FDA approval, although access was often restricted through prior authorization or step therapy and was dependent on plan choice. DISCLOSURES: Funding for this study was contributed by a student research grant awarded to Shaw and provided by the Yale School of Medicine Office of Student Research under National Institutes of Health training grant award T35DK104689. Ross reports research grants to Yale University from the U.S. Food and Drug Administration (U01FD005938, U01FD004585), Medtronic, Johnson & Johnson, Centers for Medicare & Medicaid Services (HHSM-500-2013-13018I), Blue Cross-Blue Shield Association, Laura and John Arnold Foundation, Agency for Healthcare Research and Quality (R01HS022882), and National Institutes of Health (R01HS025164), unrelated to this study. Dhruva has nothing to disclose. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Association between Higher Generic Drug Use and Medicare Part D Star Ratings: An Observational Analysis.

BACKGROUND: Increasing generic drug use, due to potential for cost savings and drug access, is a viable consideration for Medicare prescription drug plans to achieve high star ratings and improve quality of plan offerings for Medicare beneficiaries. OBJECTIVE: To examine the association between contract-level proportion of generic drugs dispensed (pGDD) and Medicare Part D star ratings. METHODS: This was a retrospective study of linked 2011 Medicare Part D star rating data with contract-level pGDD data. A total of 477 individual Medicare prescription contracts were included, representing 75% of total Prescription Drug Plans and more than 65% of total Medicare Advantage Prescription Drug Plans available by the end of 2010. Primary outcomes were Medicare Part D summary and domain star ratings (1-5 indicating lowest to highest performance), incorporating a range of quality measures for access, cost, beneficiary satisfaction, and health services outcomes and processes. Ordinal logistic regression models were used to examine associations between pGDD and Medicare Part D summary and domain star ratings, controlling for contract type and number of beneficiary enrollment. RESULTS: Higher pGDD was associated with higher summary star ratings (adjusted odds ratio 1.08 with 95% confidence interval 1.04-1.12) and higher "member experience with drug plan" domain ratings (adjusted odds ratio 1.07 with 95% confidence interval 1.03-1.11). CONCLUSIONS: Prescription formulary benefit design targeting increasing generic drug use appears to be associated with improved member experience and higher plan star ratings. Consideration may be given to incorporating pGDD into Medicare Part D star rating measures to improve quality of prescription plans.

Variation in Medication Therapy Management Delivery: Implications for Health Care Policy.

BACKGROUND: Medication therapy management (MTM) program evaluations have revealed mixed outcomes, with some studies finding favorable outcomes and others finding no differences between patients who received MTM versus those who did not. One possible reason for outcomes variability is differences in delivery of MTM programs. The Chronic Care Model (CCM) provides a framework for how health care organizations can improve care for the chronically ill through 6 elements: organization of health care, delivery system design, clinical information systems, decision support, self-management, and linkages to community resources. OBJECTIVE: To apply the CCM to understand variation in MTM delivery and formulate policy recommendations. METHODS: This study used a mixed-methods descriptive analysis of MTM delivery. Investigators conducted visits to a purposeful sample of MTM practices to observe MTM and interview participants. The pharmacists and staff of these practices completed a modified Assessment of Chronic Illness Care (ACIC). Pairs of investigators analyzed interview transcripts to identify themes. Demographics and ACIC scores were summarized using descriptive statistics. After analysis, investigators discussed overarching themes and policy implications organized by CCM elements. RESULTS: Seven practices participated, and 87 participants were interviewed. Based on ACIC scores, MTM patient volume, and payer mix, practices were categorized as Early Maturity Level or Later Maturity Level. From the model, organization of health care themes included whether MTM was the practice's core competence, belief/confidence in the MTM process, lack of formal rewards, and the influence of organizational goals and external environment. Delivery system design themes pertained to the extent that MTM processes were formalized. Clinical information systems themes were the extent to which systems were influenced by payers, efficiency strategies, and the accuracy and availability of information. In considering clinical decision support themes, alert design limitations and variation in user approaches to alerts based on experience were noted. We observed strong support for patient self-management; when present, barriers were attributed to the patient, MTM provider, or payer. Referral to community resources was minimal. Numerous policy implications were identified. CONCLUSIONS: Our research identified numerous ways by which MTM delivery varies, particularly by MTM practice maturity level. These findings provide evidence for several policy changes that could be considered to optimize MTM delivery, encourage alignment with the CCM, and promote practice maturation. DISCLOSURES: This research and a portion of Snyder's salary were supported by grant number K08HS022119 from the Agency for Healthcare Research and Quality. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Agency for Healthcare Research and Quality. Snyder reports consulting fees from Westat for an evaluation of the CMS Enhanced MTM program. The other authors have nothing to disclose. Portions of this research have been presented as abstracts at the following conferences: (a) 2017 Academy Health Annual Research Meeting; June 25-27, 2017; New Orleans, LA; (b) 2015 American Society of Health-System Pharmacists Clinical Midyear Meeting; December 4-8, 2015; New Orleans, LA; and

What Patients Know About Services to Help Manage Chronic Diseases and Medications: Findings from Focus Groups on Medication Therapy Management.

BACKGROUND: Managing and treating patients with multiple chronic conditions presents challenges on many levels. Pharmacist-delivered medication therapy management (MTM) services, mandated as part of the Medicare Part D drug benefit, are designed to help patients manage their chronic conditions and medications. OBJECTIVE: To identify factors that influence patient understanding and use of MTM services and potential strategies to educate individuals about MTM. METHODS: Participants who had at least 2 chronic conditions, were taking 2 or more prescription medications, and were aged 18 years or older were recruited from community-based settings to participate in focus groups. The focus groups aimed to identify participants' perceptions and use of MTM services, barriers and facilitators to utilization, and medication problems. Participants were asked to complete a 14-item health care questionnaire and view a brief, 3-minute video introducing the topic of MTM before the group discussion. The health care questionnaire data were analyzed in Microsoft Excel. The focus group responses were transcribed and entered into the computer program ATLAS.ti for thematic analysis. Two independent reviewers qualitatively coded the discussion question responses; a third reviewer investigated discrepancies and facilitated consensus among the reviewers. RESULTS: Participants (N = 27) were mostly female (70.4%), college educated (62.9%), and had Medicare insurance (81.5%). Seven themes were identified: (1) new proposed names for MTM, (2) mechanisms to gain interest in and to promote the value of MTM, (3) familiarity with MTM, (4) pharmacists' training and expertise in MTM, (5) experience with MTM, (6) reasons for nonparticipation in MTM, and (7) preferred method to learn about MTM. Participants did not understand the term "medication therapy management" and felt the interpretation of "therapy"' differed between health care professionals and the public. Some participants used MTM services to learn about appropriate use of their medications, while others were unsure about their eligibility, associated costs, and how to access the services. Participants had limited pharmaceutical knowledge but felt pharmacist-provided MTM services were helpful. Participants were unfamiliar with pharmacists' skills and training. Participants' experiences with MTM services ranged from disregarding the invitation to participate to having pharmacists identify drug-drug interactions. Reasons for nonparticipation in MTM services included being unaware of their eligibility, failing to read excessive information from insurance companies, and being uncertain of the identity of the telephone caller. Preferred methods for learning more about MTM services included the Internet, e-mail, information availability at physician's office, and television advertisements. CONCLUSIONS: These results suggest that the lay public remains largely unaware of MTM services and that the term "MTM" is not well understood. Clearly, tailored public health campaigns and patient engagement strategies are needed to promote MTM in chronic disease management, pharmacists as respected providers, and the importance of the prescriber-MTM pharmacist collaborative relationship in managing medications for patients with multiple chronic conditions. DISCLOSURES: Grant funding from SinfoniaRx to Taylor, Axon, Campbell, Fair, and Warholak was used to help conduct this project. Boesen is employed by SinfoniaRx. The other authors have nothing to disclose. This original research was presented as a poster at the Academy of Managed Care Pharmacy 27th Annual Meeting and Expo; April 7-10, 2015; San Diego, CA.

The Effect of Opioid Use and Mental Illness on Chronic Disease Medication Adherence in Superutilizers.

BACKGROUND: Nonadherence to essential chronic medications has been identified as a potential driver of high health care costs in superutilizers of inpatient services. Few studies, however, have documented the levels of nonadherence and factors associated with nonadherence in this high-cost, vulnerable population. OBJECTIVE: To examine the factors associated with nonadherence to essential chronic medications, with special emphasis on mental illness and use of opioid medications. METHODS: This study was a retrospective panel analysis of 2-year baseline data for Medicare Part D beneficiaries eligible for the SafeMed care transitions program in Memphis, Tennessee, from February 2013 to December 2014. The 2-year baseline data for each patient were divided into four, 6-month patient periods. The study included Medicare superutilizers (defined as patients with ≥ 3 hospitalizations or ≥ 2 hospitalizations with ≥ 2 emergency visits in 6 months) with continuous Part D coverage who had filled at least 1 drug class used to treat hypertension, diabetes mellitus, congestive heart failure, coronary artery disease, or chronic lung disease. The outcome included medication nonadherence assessed using proportion of days covered (PDC), with PDC < 80% defined as nonadherent, and the main exposure variables included mental illness (defined as a diagnosis of depression or anxiety or ≥ 1 anxiolytic or antidepressant fill) and opioid medication fills assessed in each 6-month period. Pooled observations from the four 6-month periods were used for multivariable analyses using the patient periods as the unit of analysis. A random effects model with robust standard errors and a binary distribution were used to examine associations between independent variables (time invariant and time variant factors) and medication nonadherence. The model included lagged effects of time variant factors measured in each period. RESULTS: Overall nonadherence to essential chronic medications ranged from 39.3% to 58.4%, with the highest for chronic lung disease medications (49.1%-64.4%). Factors associated with nonadherence included ≥ 4 opioid medication fills in the previous 6-month period (adjusted odds ratio [OR] = 1.90, 95% CI = 1.32-2.73); age 22-44 and 45-64 years vs. ≥ 65 years (OR = 3.57, 95% CI = 2.07-6.16, and OR = 2.07, 95% CI = 1.49-2.88); and a higher number of unique prescribers (OR = 1.10, 95% CI = 1.04-1.17). Factors protecting against nonadherence included higher number of unique medications filled (OR = 0.95, 95% CI = 0.92-0.98) and ≥ 1 physician office visit in the previous 6-month period (OR = 0.66, 95% CI = 0.46-0.94). CONCLUSIONS: This study demonstrated that high levels of opioid medication use are significantly associated with essential chronic disease medication nonadherence among superutilizers. Other risk factors for nonadherence were aged < 65 years, low-income status, and a higher number of unique prescribers. Factors protecting against nonadherence were physician office visits and filling higher number of medications. Medication management interventions targeting superutilizers should focus on supporting chronic disease medication adherence. DISCLOSURES: This project was supported by Funding Opportunity Number 1C1CMS331067-01-00 from the Centers for Medicare & Medicaid Services, Center for Medicare and Medicaid Innovation. Support was also provided by the Pharmaceutical Research and Manufacturers of America Foundation. The content of this study is solely the responsibility of the authors. The authors declare no relevant conflicts of interest or financial relationships. Study concept and design were contributed by Surbhi, Bailey, and Graetz. Surbhi and Wan collected the data, and data interpretation was performed primarily by Surbhi, along with Graetz, Bailey, and Gatwood. The manuscript was primarily written by Surbhi, with assistance from Bailey and Graetz, and revised by Bailey, Graetz, Gatwood, and Surbhi. This study was presented as a poster at the Academy Health Annual Research Meeting in Boston, Massachusetts, on June 26-28, 2016.

Assessing student knowledge, confidence, accuracy, and proficiency in providing Medicare Part D assistance.

PURPOSE: To assess the impact of coordinated didactic, simulation-based, and experiential learning on pharmacy students' knowledge and confidence with Medicare Part D and their accuracy and proficiency with the Medicare Plan Finder Tool. EDUCATIONAL ACTIVITY: Forty-two pharmacy students participated in a two-semester Medicare Part D elective course in which didactic, simulation-based and experiential learning methods were employed. Students' knowledge, confidence, accuracy, and proficiency were assessed at three course time points: first day of class, last day of in-class education, and after completion of outreach. FINDINGS: Student confidence with Part D and efficiency using the Plan Finder Tool significantly improved at each successive time point (p<0.01). Student knowledge was significantly improved both on the last day of class and after outreach completion as compared to the first day of class (p<0.01). SUMMARY: Basic Part D knowledge improved with the didactic and simulation-based portion of the course. The experiential component improved student confidence and efficiency in helping Medicare beneficiaries.