Costs and health care resource utilization among Medicare beneficiaries diagnosed with chronic lymphocytic leukemia.

BACKGROUND: Chronic lymphocytic leukemia (CLL) is the most common type of leukemia. However, published studies of CLL have either only focused on costs among individuals diagnosed with CLL without a non-CLL comparator group or focused on costs associated with specific CLL treatments. An examination of utilization and costs across different care settings provides a holistic view of utilization associated with CLL. OBJECTIVE: To quantify the health care costs and resource utilization types attributable to CLL among Medicare beneficiaries and identify predictors associated with each of the economic outcomes among beneficiaries diagnosed with CLL. METHODS: This retrospective study used a random 20% sample of the Medicare Chronic Conditions Data Warehouse (CCW) database covering the 2017-2019 period. The study population consisted of individuals with and without CLL. The CLL cohort and non-CLL cohort were matched using a 1:5 hard match based on baseline categorical variables. We characterized economic outcomes over 360 days across cost categories and places of services. We estimated average marginal effects using multivariable generalized linear regression models of total costs and across type of services. Total cost was compared between CLL and non-CLL cohorts using the matched sample. We used generalized linear models appropriate for the count or binary outcome to identify factors associated with various categories of health care resource utilization, such as inpatient admissions, emergency department (ED) visits, and oncologist/hematologist visits. RESULTS: A total of 2,736 beneficiaries in the CLL cohort and 13,571 beneficiaries in the non-CLL matched cohort were identified. Compared with the non-CLL cohort, the annual cost for the CLL cohort was higher (CLL vs non-CLL, mean [SD]: $22,781 [$37,592] vs $13,901 [$24,725]), mainly driven by health care provider costs ($6,535 vs $3,915) and Part D prescription drug costs ($5,916 vs $2,556). The main categories of health care resource utilization were physician evaluation/management visits, oncologist/hematologist visits, and laboratory services. Compared with beneficiaries aged 65-74 years, beneficiaries aged 85 years or older had lower use and cost in maintenance services (ie, oncologist visits, hospital outpatient costs, and prescription drug cost) but higher use and cost in acute services (ie, ED). Compared with residency in a metropolitan area, living in a nonmetropolitan area was associated with fewer physician visits but higher ED visits and hospitalizations. CONCLUSIONS: The cooccurrence of lower utilization of routine care services, along with higher utilization of acute care services among some individuals, has implications for patient burden and warrants further study.

Disparity in treatment patterns among Medicare beneficiaries diagnosed with chronic lymphocytic leukemia: an analysis of patient and contextual factors.

This study characterizes the patterns and timing of CLL treatment and, to our knowledge, is the first to identify social vulnerability factors associated with CLL treatment receipt in the Medicare population. A total of 3508 Medicare beneficiaries diagnosed with CLL from 2017 to 2019 were identified. We reported the proportion of individuals who received CLL treatment and the time until the first CLL treatment receipt after the first observed claim with a CLL diagnosis. Logistic regression and time-to-event models provided adjusted odds ratios and hazard ratios associated with baseline individual-level and county-level factors. Sixteen percent of individuals received CLL treatment, and the median follow-up time was 540 d. The median time to receipt of CLL treatment was 61 d. Older age and residence in a county ranked high in social vulnerability (as defined by minority status and language) were negatively associated with treatment receipt and time to treatment receipt.

Assessing suboxone access in community pharmacies: Secret shopper model.

Objective: To assess whether Maryland community pharmacies had Suboxone available for dispensing. Methods: This cross-sectional study used a secret shopper model to contact public-facing community pharmacies in Maryland. The secret shopper, guided by a script, asked whether a prescription for Suboxone was available for the same or next day pick-up. A small convenience sample of pharmacies who did not have Suboxone available received an in-person visit to inquire about medication availability and dispensing barriers. Results: After contacting 99% (n = 1046) of Maryland public-facing pharmacies, Suboxone was confirmed available for immediate pick-up in 31% (n = 326). The remaining did not have, would not disclose, or had limited access (existing patients or specific providers only). Significant differences in Suboxone availability were found for National Capital vs. Baltimore metro region and when pharmacist asked questions vs. no questions. Of the 11 pharmacy visits completed, 10 said they had Suboxone currently in stock, with one clarifying medication was for existing patients only. Conclusion: About 69% of patients may face challenges when calling to find out whether they can obtain Suboxone in Maryland pharmacies. Better patient education and more thorough pharmacy-level investigation of system and workflow barriers could offer solutions.

Efficacy of a Flavored Lubricating Oral Spray on Medication Swallowing in Older Individuals.

Background Difficulty swallowing occurs in up to 35% of patients 50 years of age or older and can contribute to medication nonadherence and other alterations. The use of a flavored lubricating spray, available over-the-counter and found to be helpful in children to swallow oral solid medications, is not well studied in older adults. Objective To evaluate the effect of a flavored lubricating spray on the ability to swallow oral solid medication in older people. Methods A randomized, open-label, crossover study included community-dwelling individuals 65 to 88 years of age who took at least one solid oral medication daily and were not diagnosed with dysphagia, Parkinson's disease, or esophageal tumor. Participants were randomized to the strawberry-flavored lubricating spray or usual care and then crossed over to the alternate option. The median rating for swallowing difficulty for their regular medications was compared using a Likert scale, from 1 (very difficult) to 5 (very easy). To provide a degree of standardization between participants, all participants were also instructed to swallow a vitamin C (1,000 mg) tablet both with and without the flavored spray and rate their difficulty swallowing the tablet using the same Likert scale. Results There were 39 (90.7%) participants who completed the study. The median rating for swallowing difficultly was 5 (very easy) with the spray vs. 4 (easy) with usual care (P < 0.0001). For the 66.7% who took the vitamin C tablets, the median rating for swallowing difficulty was 5 (very easy) with the spray vs. 3.5 (between neutral and easy) without (P < 0.0001). There were 94.8% of participants who found the spray easy/ very easy to use, and 89.7% reported it tasted okay to delicious. Conclusion The use of a flavored lubricating spray provided an effective and easy-to-use tool to make medication swallowing easier in community-dwelling older adults without a diagnosis associated with difficulty swallowing.

Social determinants predict whether Medicare beneficiaries are offered a Comprehensive Medication Review.

BACKGROUND: Medication reviews through Medicare's Medication Therapy Management (MTM) program may improve patient outcomes and lower health system costs, but these effects could be limited by a program design that does not address social determinants of health. OBJECTIVE: To analyze the effects of social determinants of health on the odds of an eligible Medicare beneficiary not being offered Comprehensive Medication Review (CMR). METHODS: Using the full 100% sample of the 2016 Part D Medication Therapy Management Data File linked to Medicare Master Beneficiary Summary File, a retrospective, cross-sectional analysis was conducted to determine which social and demographic variables are most strongly associated with being eligible for a CMR but not being offered one. Descriptive statistics were generated using SAS studio 3.8. RESULTS: Variables associated with the highest odds of not receiving a CMR when eligible are residence in Louisiana OR 1.79 (95%CI 1.70-1.88), receiving the LIS OR 1.76 (1.73-1.79), dual eligibility for Medicare and Medicaid OR 1.25 (1.12-1.41), and Black race OR 1.19 (1.16-1.21). CONCLUSIONS: Social determinants of health, most strongly geography and low-income status, predict being eligible for but not being offered CMR. Race continues to be a factor in disparate access to MTM services.

Evolution of the Comprehensive Medication Review Completion Rate for Medicare Part D Plans: What Do the Stars Tell Us?

Objective To describe changes in the Medicare Part D Comprehensive Medication Review (CMR) completion rate within the Centers for Medicare & Medicaid Services (CMS) Star Ratings program since its inception. Methods Publicly available information for Star Ratings years 2014 to 2021 was obtained from the CMS website and through indexed literature and internet searches. Data elements for the CMR completion measure were extracted for Medicare Advantage prescription drug plans (MA-PDs) and prescription drug plans (PDPs) and included the annual weighted value, cut-points for star rating, completion rates, and star achievement. Results In 2014 and 2015, the CMR completion rate was a display measure in the Star Ratings program with rates between 10 and 16%. This measure was added in 2016 with a weighted value of 1 that has remained the same. The cut-points when comparing 2016 with 2021 have increased from less than 13.6 to less than 48% for 1 star and 76 to 89% or more for 5 stars for MA-PDs and from less than 8.5 to less than 24% for 1 star and 36.7 to 61% or more for 5 stars for PDPs. From 2016 to 2021, the average Star Ratings for CMR completion increased from 2.3 to 3.7 for MA-PDs and 2.3 to 3.6 for PDPs. Conclusion Since the inception of the CMR completion rate as a quality measure, an increasing proportion of eligible beneficiaries has received a CMR with MA-PDs consistently providing this service to more beneficiaries than PDPs. The cut-points for star achievement have also risen, requiring higher CMR completion rates to achieve higher star ratings. Further evolution of the CMR quality measure is needed for improving medication management.

Opioid prescribing patterns in a commercially insured population.

BACKGROUND: Claims data evaluations have advanced our understanding about patient risk factors and predictors for opioid misuse and aid in patient identification. However, less evidence is available to guide the identification of prescribers with at-risk prescribing practices. Thus, an algorithm was developed to identify prescribers with outlying patterns of opioid prescriptions in a managed care organization. METHODS: A retrospective analysis used enrollment, prescription, and medical claims data from September-December 2019 to identify prescribers of schedule II, III or IV opioid analgesic medications. Criteria were used to characterize these prescribers as frequent, continuous, and/or high-dose prescribers of opioids. RESULTS: For prescribers with > 25 patients with any prescriptions, the algorithm identified 5136 prescribers who had prescribed at least one opioid. This group of prescribers accounted for 53.9% of the total opioids prescribed and wrote an average of 6.5 opioid prescriptions per prescriber during a 3-month period. There were 629 prescribers (12.2%) that had prescribed an opioid to ≥ 50% of their population (frequent prescribers); 493 prescribers (9.6%) that had prescribed >185 day-supply of opioids within 6 months to 10% or more of their population (continuous prescribers); 147 prescribers (2.9%) that had prescribed an average daily MME > 90 mg to ≥ 10% of their population in the most recent 90 days (high-dose prescribers); and 47 prescribers (0.9%) that met all three criteria. CONCLUSIONS: The algorithm identified a targeted prescriber group to employ resources to mitigate opioid misuse and abuse. Flexible criteria for frequent, continuous, and/or high-dose prescribing allows tailoring to the needs of different managed care organizations.

Implementation of academic detailing for pharmacists on opioid use disorder and harm reduction.

BACKGROUND: The United States is experiencing an opioid crisis, substantially worsened by the pandemic. Pharmacists play a critical role in expanding access to care through harm reduction efforts and medications to treat opioid use disorder (mOUD), yet lack necessary education and resources. Academic detailing is a one-on-one technique, which can effectively address educational gaps. OBJECTIVE: The purpose was to assess needs and equip pharmacy staff to address the health of people with substance use disorders (SUD). PRACTICE DESCRIPTION: Community pharmacists provide ongoing care for patients with SUD. PRACTICE INNOVATION: Based on needs' assessment findings, an academic detailing program was designed to provide education and resources for community pharmacies. The project sought to assess current practice and needs and address pharmacists' skills in managing patients with opioid use disorder (OUD) and/or at risk for overdose (OD). Visits were scheduled in high-risk regions. Coaching and materials were provided. EVALUATION METHODS: Detailers completed visits reports. Discrete variables were reported using descriptive statistics. Associations between discrete variables were detected with Chi-square or Fisher's exact test. RESULTS: Detailers visited 136 pharmacies. Most stocked naloxone (86.8%), mOUD (94.9%) and would sell syringes (64%) per state law. Fifty-seven percent of pharmacies provided all of these services. However, additional education and resources were needed. Only 27.9% had naloxone signage and/or handouts; 22.1% had supplemental materials; and 25% had referral information. When asked to explain barriers, frequently cited themes included providing resources/help, financial issues, stigma, and transportation. CONCLUSION: Pharmacists routinely care for patients at risk for OD and diagnosed with OUD. Academic detailing is a well-received strategy to disseminate education and materials, while gathering information about pharmacist needs and barriers. However, there remains room for expansion of services and opportunities for improved care. Further efforts should incorporate ongoing training and access to materials with visual cues, as well as referral and cost savings information.

Initial non-adherence to antihypertensive medications in the United States: a systematic literature review.

An important component of hypertension management is the initiation and continuation of antihypertensive medications. Non-adherence during the long-term use of antihypertensive medications is well studied. However, there is a paucity of research about the frequency and clinical consequences of failing to take the first dose of an antihypertensive, a treatment challenge known as initial medication non-adherence (IMN). This systematic literature review summarizes the published evidence from 2010 to 2019 on the prevalence, associated factors, consequences, and solutions for IMN to antihypertensive medications in the United States. Of the fifteen studies identified, nine studies reported the prevalence of IMN, two studies examined patient-reported reasons for IMN, and four studies evaluated interventions aimed to lower IMN. It is estimated that 5-34% of patients do not obtain their new antihypertensive medications. Factors and reasons cited include patient demographics, patient beliefs or perceptions about medications, cost or financial barriers, and clinical characteristics, such as a new hypertension diagnosis or higher co-morbid disease burden. The clinical, economic, and patient-reported outcomes of IMN are not well researched. In addition, interventions to address IMN have yielded inconsistent results. Significant opportunities exist for further research into this dimension of patient behavior to better understand and address IMN to new antihypertensive medications.

Improving Medication Management by Understanding Patient and Caregiver Preferences for Medication Packaging.

OBJECTIVE: To assess older adults' perceptions and preferences when comparing multi-medication packaging products.
DESIGN: Qualitative study involving focus group interviews (FGIs) and key informant interviews (KIIs).
SETTING: Interviews were conducted in multiple cities within the United States during June-July 2019.
PATIENTS, PARTICIPANTS: FGI participants (N=36) included community dwelling adults, 65 years of age or older, who took 5+ chronic medications, or their caregivers. KII participants (N=15) included health care professionals caring for similar populations.
INTERVENTIONS: Participants were given samples of blister packs and pouches and asked about medication management and appearance and usability of medication packaging. Interviews were audio-recorded with participants' consent, then transcribed and coded using Atlas. ti. Recurrent and emergent themes were identified, and selected quotes served as examples of identified themes.
MAIN OUTCOME MEASURE: Participants' perceptions regarding medication packaging.
RESULTS: Participants' preferences varied for different multi-medication packaging systems. Similarly, most FGI participants did not communicate a strong attitude for or against their existing management systems. However, many FGI participants perceived a need for larger font size than seen on the either of the multimedication packaging samples. KII participants also preferred a larger font size on both packagings. KII participants thought the blister packs offered better visual organization and enabled caregivers to quickly assess adherence. However, KII participants expressed concern about integrating as-needed and short-term use medications and noted difficulty opening both types of packages.
CONCLUSION: Visual appearance is important to both patients and health care providers. Continued research in this area is vital for tailoring packaging types and technology to patients.

Understanding the Socioeconomic and Geographical Characteristics of Beneficiaries Receiving a Comprehensive Medication Review.

BACKGROUND: Medicare Part D sponsors are required to offer medication therapy management (MTM) programs to eligible beneficiaries. Recent studies have demonstrated that there have been racial/ethnic disparities in MTM eligibility criteria. For example, compared with non-Hispanic White beneficiaries, Hispanic and non-Hispanic Black beneficiaries are less likely to be eligible for MTM. However, there is limited evidence for socioeconomic and geographical characteristics of those who are eligible and receive MTM services. OBJECTIVE: To describe the demographic, socioeconomic, and geographic characteristics of Medicare beneficiaries who received MTM services. METHODS: As part of a previous study, a national survey evaluated a convenience sample of perspectives of Medicare beneficiaries on the MTM standardized format. The survey was distributed through Medicare Part D plans to beneficiaries receiving MTM services from 2017-2018. As part of the survey, respondents could provide their ZIP codes. Geographical variables, such as the National Center for Health Statistics (NCHS) urban-rural classification scheme and economic research service (ERS) county typology codes, were then applied to respondents' ZIP codes, allowing for the classification of counties or census tracts by urbanization and economic dependence measures. Descriptive statistics are reported for demographic, geographical, and socioeconomic information. RESULTS: Of the 300 (of 434) respondents who provided their ZIP codes, 51.3% were aged 65-74 years; 50% were male; and 66.7% had at least a college education. There were 82.7% who self-identified as White, while only 8% self-identified as Hispanic or Black/African American. The majority of respondents (58.4%) lived in large metropolitan areas as defined by the NCHS urban-rural classification scheme. Respondents' counties were characterized by economic dependence with 14.0% of respondents living in federal/state government-dependent counties and 12.7% living in recreation-dependent counties. CONCLUSIONS: The majority of respondents who provided their ZIP codes identified themselves as White and lived in large metropolitan areas. Respondents who identified themselves as Hispanic or Black/African American were not well represented. This study provides geographical and socioeconomic characteristics of Medicare beneficiaries who received MTM services and highlights racial/ethnic differences. Further work is needed to confirm geographical and socioeconomic disparities among beneficiaries who received MTM services. DISCLOSURES: No outside funding supported this study. Pellegrin is a member of the AMCP MTM Advisory Group. The other authors have nothing to disclose.

Online Provision of Part D Medication Therapy Management Program Information.

BACKGROUND: Low rates of beneficiary participation in medication therapy management (MTM) programs may be partly due to lack of awareness and understanding of the MTM program. To address this, the Centers for Medicare & Medicaid Services (CMS) requires Medicare Part D sponsors to provide online information about their MTM programs. An early study conducted in 2014 found low compliance rates, with only 59.5% of a small convenience sample of Part D plan contract websites compliant with CMS requirements. The current study provides a more recent evaluation of compliance with website requirements using a random sample of Part D plan contracts. OBJECTIVES: To (a) evaluate Part D sponsors' compliance with MTM program website elements that are required and suggested by CMS and (b) investigate the use of elements recommended by the National Institute on Aging (NIA) for websites for older adults. METHODS: A random sample of 184 Part D plan contract MTM program websites was selected from a list of 624 approved Part D plan contracts for 2016. Duplicate and inaccessible websites were excluded. The remaining websites were reviewed to determine compliance with CMS-required, CMS-suggested, and NIA-recommended elements. Descriptive statistics were reported at the Part D contract level for compliance with individual elements, category elements (CMS-required, CMS-suggested, and NIA-recommended), and overall compliance. Overall compliance by category was also reported by Part D plan type. RESULTS: Of the 184 MTM websites that were reviewed, 106 remained after excluding duplicate (n = 67) and inaccessible (n = 11) websites: 81 from Medicare Advantage prescription drug (MAPD) plans, 16 from prescription drug plans (PDPs), and 9 from Medicare-Medicaid plans (MMPs). Overall, 51% of Part D plan contract MTM websites were compliant with all of the 14 CMS-required elements. The only element in the CMS-suggested elements category, "accessibility by clicking through a maximum of two links," had a compliance rate of 79%. For the NIA-recommended elements category, 46% of the Part D plan contract MTM websites were compliant with the 4 elements. CONCLUSIONS: Medicare Part D plan sponsors are providing information about their MTM programs on plan websites. However, only 51% of Part D plan websites are fully compliant with CMS guidance, providing all required elements. DISCLOSURES: No outside funding supported this study. The authors have no financial or other relationships to disclose. The original research on a small and nonrandom sample of Part D plan contracts was presented during AMCP Nexus 2014; October 7-10, 2014; in Boston, MA. The results presented here are a larger and random sample of Part D plan contracts.

Beneficiary, Caregiver, and Case Manager Perspectives on the Medication Therapy Management Program Standardized Format.

Plan sponsors of Medicare Part D must provide beneficiaries who receive a comprehensive medication review (CMR) with a written summary using the Medicare Part D Medication Therapy Management Standardized Format (SF). The SF is a means to advance consistency in the CMR program by providing a template of expected content. However, barriers remain with beneficiary use and integration into existing electronic health records. The current study assessed Medicare beneficiary, caregiver, and case manager perceptions of the SF through five focus group interviews with a total of 23 participants. Qualitative analysis found that beneficiaries and case managers preferred a consolidated SF document to share and update their entire health care team. Beneficiaries suggested adding information to the SF on dosage, timing, drug interactions, cost, and less expensive alternatives. Identifying elements of the SF that are perceived as useful to beneficiaries will allow for a more streamlined SF that may enhance interoperability among the health care team. [Journal of Gerontological Nursing, 45(4), 7-13.].

Findings from a National Survey of Medicare Beneficiary Perspectives on the Medicare Part D Medication Therapy Management Standardized Format.

BACKGROUND: The Medication Therapy Management (MTM) Program Standardized Format (SF) is a written summary of a comprehensive medication review (CMR) that must be provided to Medicare Part D beneficiaries. Concerns have been raised regarding the number of pages of the SF, mailing costs, the static nature of the document, and the lack of integration into beneficiaries' electronic health records. To date, limited research exists on beneficiaries' perceptions of the SF. OBJECTIVE: To evaluate the perspectives of beneficiaries regarding the utility of the SF to inform potential modifications for optimal use. METHODS: An online survey, designed based on the standard approach to measuring patient satisfaction with health service attributes and previous qualitative research, was distributed through Medicare Part D plans to beneficiaries who had received a CMR in the past year. Survey distribution began July 1, 2018, and data collection ended on October 31, 2018. Descriptive statistics are reported for demographic information; health status; perceived value and helpfulness of the SF and its 3 components (cover letter, medication action plan [MAP], personal medication list [PML]); updates to the SF; alternate formatting; and integration of the SF into health records. RESULTS: A total of 9,975 surveys were sent electronically by 4 Medicare Part D plans to beneficiaries who had received a CMR in the past year. Of the 434 unduplicated survey respondents (response rate of 4.3%), 58.5% were aged 65 to 84 years; 60% identified themselves as white; and 49.1% had at least a college education. The most commonly reported comorbidities were diabetes (50.5%) and high cholesterol (43.1%), with 10.7% of respondents rating their health as "very good" or "excellent" and 27.4% choosing "poor" or "fair." Beneficiaries rated how well the SF helped improve different aspects of their medication management (e.g., solving medication-related problems, keeping track of medications, correctly using medications, and understanding why medications are being taken), with 40.8%-44.9% choosing "very good" to "excellent" for each aspect. Helpful sections included "What we talked about" and "What I need to do"for the MAP, and medication name, strength, dosage form, and "How and why I use the medication" for the PML. Less helpful were the fill-in sections of the MAP, with 48.6% reporting that they did not write in any information. In contrast, 44.7% of the participants noted that they updated their PML. A wallet card version of the PML, if available, would be used by 54.6% of participants. About one third of Medicare beneficiaries shared the SF with their doctor, and 26% of the participants gave copies of their medication summary to their relatives. CONCLUSIONS: Fewer than half of the respondents perceived the SF as very good or excellent in helping them to manage their medications. This national survey provides Medicare beneficiary-focused evidence that more work is needed to improve the usability and portability of the SF. This can be achieved by allowing flexibility in the design of the SF, while including essential elements. DISCLOSURES: This study was funded by the Academy of Managed Care Pharmacy (AMCP), which provided a grant to the University of Maryland School of Pharmacy to conduct this study. Carden and Kumbera are AMCP employees. Brandt reports a grant from IMPAQ and consulting fees from Rand, outside of this study. Pellegrin is a member of the AMCP MTM Advisory Board. The other authors have nothing to disclose.

Medication errors in community pharmacies: The need for commitment, transparency, and research.

Medication errors place a serious medical and economic burden on the United States (U.S.) healthcare system. Since 1975, government health agencies and non-profit organizations in the U.S., such as the Agency for Healthcare Research and Quality (AHRQ), the Institute of Medicine (IOM), and the Joint Commission, have undertaken initiatives intended to reduce medication errors, and there has been noteworthy progress in inpatient settings. However, there have been fewer advances in settings outside the hospital such as community pharmacies, where 4 billion prescriptions were dispensed to patients in 2017. There are limited information and research on community pharmacies' involvement in reducing and preventing medication errors. Most published studies on medication errors in community pharmacy settings are cross-sectional in design and often limited by geography, such that each study describes a single geographic region, i.e., one or a few practices in a single city or state within the U.S. An attempt to gain additional insight on how medication errors are managed was met with the inability of many pharmacy corporations to provide meaningful information. In order to reduce medication errors, improvement strategies such as transparency and bi-directional communication between pharmacists and patients are needed. Pharmacists are required by law to counsel patients, and research has shown that counseling can assist with detecting medication errors. Community pharmacies play a significant role in the U.S. healthcare system, but their efforts to reduce medication errors are not well known. By improving transparency in quality assurance processes and promoting patient engagement to improve patient safety, community pharmacies have the potential to play a more active role in reducing medication errors and safeguarding patients from harm.

Evolution of the Medicare Part D Medication Therapy Management Program from Inception in 2006 to the Present.

BACKGROUND: In 2006, the Centers for Medicare & Medicaid Services (CMS) implemented the newly established Medicare Part D program that required plan sponsors to offer a medication therapy management (MTM) program. The MTM program requirements have become more prescriptive over the past decade in the attempt to address low beneficiary enrollment rates, improve the quality of services provided, and address gaps in meeting the needs of enrollees. OBJECTIVE: To describe changes to the requirements for the Medicare Part D MTM program since its inception in 2006 and the impact of these changes to inform future program enhancements. METHODS: We obtained publicly available information extracted from the Medicare Part D MTM program fact sheets for the years 2008 through 2018, in addition to searching indexed literature through PubMed and additional literature through Internet searches. We then categorized the program's requirement changes annually, and described the Part D MTM program characteristics and reported statistics. DISCUSSION: Significant changes to the Part D MTM program requirements occurred in 2010, 2013, and 2016 regarding eligibility criteria, MTM services, and reporting requirements. Thresholds to determine beneficiary eligibility have been lowered. Specific MTM services now include an annual comprehensive medication review, followed by a written summary using the Standardized Format. Quarterly targeted medication reviews are also required. Reporting requirements now include comprehensive medication review completion rates and the number of prescriber interventions, among others. Despite more prescriptive MTM program requirements, the low utilization of the MTM program continues. CONCLUSION: Low beneficiary enrollment rates in the Medicare Part D MTM program led CMS to lower thresholds required for eligibility to expand the beneficiary pool. More prescriptive MTM service requirements enhanced service standardization. Despite these changes, MTM enrollment and comprehensive medication review rates remain low, likely, in part, from a lack of financial incentives. The Enhanced MTM program is a 5-year test model that is providing participating Part D plans regulatory flexibility and financial incentives to design their own MTM programs, to evaluate the impact of different program designs on beneficiary engagement and outcomes.

Impact of formulary restrictions on medication intensification in diabetes treatment.

OBJECTIVES: To explore formulary restrictions on noninsulin antihyperglycemic drugs (NIADs) in Medicare Part D plans and to estimate the impact of formulary restrictions on use of NIADs among low-income subsidy (LIS) recipient enrollees with type 2 diabetes (T2D) undergoing treatment intensification. STUDY DESIGN: Retrospective cohort study. METHODS: A cohort of 2919 LIS enrollees with T2D receiving metformin monotherapy during the first quarter of 2012 who intensified treatment later in the year was tracked to assess selection of and days' supply with sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors, and other NIADs. We tested whether being enrolled in a Part D plan with significant formulary restrictions on sole-source brand name NIADs reduced the likelihood of receiving such agents and, if so, what the impact was on days of therapy with the second agent. A 2-part regression model was estimated with explanatory variables for plan-level restrictions and individual covariates. RESULTS: We found that 63% of study subjects initiated a sulfonylurea, 25% a DPP-4 inhibitor, and 12% another NIAD. Greater restrictions on DPP-4 inhibitors as a class were associated with small reductions in initiation of DPP-4 inhibitors and a concomitant increase in use of sulfonylureas, but neither effect was statistically significant. For individual DPP-4 inhibitors, step therapy requirements on sitagliptin and formulary exclusion of saxagliptin resulted in significant reductions in uptake of the specific drugs but had no significant impact on total days' supply of antihyperglycemic therapy. CONCLUSIONS: Part D formulary restrictions on sole-source brand name NIADs had little impact on patterns of treatment intensification for T2D among LIS recipients enrolled in Medicare Part D plans in 2012.

Clinical, economic, and humanistic burden of needlestick injuries in healthcare workers.

INTRODUCTION: Needlestick injuries (NSIs) from a contaminated needle put healthcare workers (HCWs) at risk of becoming infected with a blood-borne virus and suffering serious short- and long-term medical consequences. Hypodermic injections using disposable syringes and needles are the most frequent cause of NSIs. OBJECTIVE: To perform a systematic literature review on NSI and active safety-engineered devices for hypodermic injection. METHODS: MEDLINE, EMBASE, and COCHRANE databases were searched for studies that evaluated the clinical, economic, or humanistic outcomes of NSI or active safety-engineered devices. RESULTS: NSIs have been reported by 14.9%-69.4% of HCWs with the wide range due to differences in countries, settings, and methodologies used to determine rates. Exposure to contaminated sharps is responsible for 37%-39% of the worldwide cases of hepatitis B and C infections in HCWs. HCWs may experience serious emotional effects and mental health disorders after a NSI, resulting in work loss and post-traumatic stress disorder. In 2015 International US$ (IntUS$), the average cost of a NSI was IntUS$747 (range IntUS$199-1,691). Hypodermic injections, the most frequent cause of NSI, are responsible for 32%-36% of NSIs. The use of safety devices that cover the needle-tip after hypodermic injection lowers the risk of NSI per HCW by 43.4%-100% compared to conventional devices. The economic value of converting to safety injective devices shows net savings, favorable budget impact, and overall cost-effectiveness. CONCLUSION: The clinical, economic, and humanistic burden is substantial for HCWs who experience a NSI. Safety-engineered devices for hypodermic injection demonstrate value by reducing NSI risk, and the associated direct and indirect costs, psychological stress on HCWs, and occupational blood-borne viral infection risk.