Avalere Few Medicarebeneficiaries Receive Comprehensive Medication Review Serivecs

On January 1, 2006, Medicare beneficiaries were beginning able to access the Part D benefit either through a Medicare Reward prescription drug program or a stand-alone prescription drug programme.ⁱ Along with providing prescription drug coverage, Medicare Part D sponsors were also required to offer a medication therapy management (MTM) programme to eligible beneficiaries.² Through the MTM program, pharmacists or other qualified providers collaborate with patients and/or their healthcare providers to ensure that medications are appropriately used to optimize therapeutic outcomes and reduce the risk for adverse events.²

The Pharmacy Quality Brotherhood, an organisation that develops strategies for measuring and reporting performance information related to medications, has endorsed a measure that is now required by the Centers for Medicare & Medicaid Services (CMS) for MTM programs.³ With a focus on achieving optimal medication utilise, CMS has updated the requirements for MTM programs several times since its inception in 2006.

The purpose of this article is to describe the changes to the Medicare Part D MTM programme requirements over the years and the touch these changes have had on Medicare beneficiaries with the goal of informing hereafter program enhancements.

Methods

In this review, we examined policy changes in the Medicare Part D MTM program based on data constitute by searching the CMS website, PubMed, and through Google searches. The search bar on the homepage of the CMS website (www.cms.gov) was used to identify Medicare Role D MTM program fact sheets and call letters betwixt 2006 and December 2018. The CMS MTM fact sheets provide almanac reviews of the MTM program, whereas the call letters item the upcoming year's MTM program requirements.

We used the PubMed database search to identify peer-reviewed published articles. The search terms were "Medication Therapy Management" as a major medical subject heading and "Medicare and policy." The gray literature was searched using Google search engine by combining "Medication Therapy Management" or "MTM" with "Medicare" or "Part D," and "policy," "modify," or "implications." The PubMed and Google searches were initially performed in Oct 2016 and were repeated in March 2018 to identify the additional Part D MTM program requirements and policy implications since our initial search.

At the time of our research, ¹¹ publicly available Medicare Part D MTM program fact sheets were available for 2008 through 2018 on the CMS website; however, the 2008 fact sheet is no longer available.^4-13 Although these were created starting in 2006, fact sheets for 2006 and 2007 were non publicly available. The nearly recent fact sheet for 2018 was published on Baronial 20, 2018.¹³

Evolution of the MTM Program

The initial design of the Medicare Function D program required Medicare beneficiaries to run into three criteria to be eligible for the MTM services, including⁴:

1. Accept multiple chronic diseases
2. Take multiple drugs covered past Medicare Role D
3. Be probable to incur almanac costs for covered Part D drugs that exceed a predetermined level.

Several changes have been fabricated to the initial Part D MTM program eligibility criteria (Table).^4,5,7,8 Since 2006, Office D program sponsors were required to target beneficiaries who had multiple chronic diseases with a minimum specified threshold of 2 to five chronic diseases.^iv In defining multiple chronic diseases, sponsors had to indicate if they would target any chronic disease or only specific chronic diseases.

In 2010, CMS added a ceiling and a floor for the minimum number of chronic diseases that may be required. At least 2 or three chronic diseases were required to qualify for Function D MTM services. In 2010, approximately 72% of Part D MTM programs required a minimum threshold of 3 chronic diseases compared with but 51% in 2008 (Figure ane).^4-13 Plan sponsors go on to prepare restrictive criteria, and in 2018, approximately 87% of plans still required a minimum of 3 chronic conditions; the 2019 program requirements for Office D MTM programs are unchanged from agenda years 2017 and 2018.^13,14

In 2008, CMS likewise ready a required minimum range of 2 to 15 Part D–covered drugs that beneficiaries had to be taking to receive MTM services.⁴ In 2010, this range changed to a minimum requirement of 2 to eight covered drugs.⁵ In 2009, 28.5% of plans restricted enrollment to patients taking 8 or more than Part D drugs,⁴ which increased to 66.4% in 2010 (Figure 2).^4-xiii In every year since 2010, the majority of Part D plans have required the utilise of eight Part D drugs for a beneficiary to meet program eligibility, with 71% of plans requiring eight or more than Function D drugs in 2018.¹³

In 2009, beneficiaries also had to be likely to incur an annual toll of at least $4000 for covered Role D drugs to be eligible for the MTM program.⁴ In 2010, the annual cost threshold was lowered from $4000 to $3000.^v In 2012, this threshold increased slightly from $3000 to $3100.^xx and has connected to increment annually by a specified annual percentage.^vii The annual price thresholds for 2018 and 2019 were $3967 and $4044, respectively.^thirteen,14

Since their implementation in 2006 through 2009, most Medicare Part D MTM programs have been identifying eligible beneficiaries on a monthly or quarterly basis by running their targeting algorithms.⁴ The 2010 CMS regulations required Part D plans to at least identify (or target) beneficiaries on a quarterly ground for enrollment in their MTM program.⁵ In 2009, the methods of enrollment were "opt in" (ie, eligible beneficiaries must actively enroll), "opt out" (ie, eligible beneficiaries are automatically enrolled), or a combination of both.^four However, since 2010, CMS has only allowed an opt-out method.^5-13

Targeted Interventions

Initially, the Office D MTM program was designed to include any type or combination of MTM interventions (Table). Program sponsors could decide whether services were provided to the beneficiary and/or the healthcare provider. Sponsors could provide MTM services via telephone, e-postal service, mail, or whatever combination of these commitment vehicles. The nearly mutual MTM interventions reported by Part D programme sponsors for 2009 were medication reviews, refill reminders, intervention messages, educational newsletters, prescriber consultations, drug interaction screenings, case direction, and a medication profile or list.^four

In 2010, plan sponsors were required to offer a minimum level of MTM services for beneficiaries enrolled in the MTM program, including interventions for beneficiaries and prescribers.⁵ These minimum services included an annual comprehensive medication review and quarterly targeted medication reviews.⁵ In 2013, information technology became mandatory to provide beneficiaries with a written summary of their comprehensive medication review in a specified certificate, which was named the Standardized Format.¹⁵

The Standardized Format provided a means to document expected content in a consequent class. Long-term intendance beneficiaries who had been initially excluded from the comprehensive medication review requirement were now included in the 2013 changes.⁷ In 2010, plan sponsors were as well able to provide additional services across those required services, and 48.four% of MTM programs provided a general education newsletter to the beneficiary, 15.2% programs had a refill reminder, and 10.3% instituted a case-direction referral.⁵

MTM Program Reporting

Before 2010, Part D plan sponsors were required to written report several program-specific data elements to CMS, including the number of beneficiaries eligible for MTM services, the reasons beneficiaries opted out of the MTM program, and the costs and total numbers of 30-day prescription equivalents for each participating beneficiary.^sixteen Starting in 2008, specific data nigh services rendered at the beneficiary level were likewise required to be reported past sponsors.¹⁶

Starting in 2010, the reporting requirements expanded to include⁶:

• The percent of beneficiaries receiving a comprehensive medication review
• The number of targeted medication reviews conducted
• The number of prescriber interventions
• Changes in medication therapy resulting from ­interventions.

The goal of expanding these data-reporting elements was to enable a more vigorous analysis of the MTM program and the interventions to evaluate all-time practices.

CMS publicly reports how well Role D drug plans perform on several categories, such as quality of care and customer service, using the Star Rating Arrangement.¹⁷ The MTM program completion charge per unit for comprehensive medication reviews (ie, the percentage of Part D plan members aged ≥18 years who received a comprehensive medication review among all those who met the eligibility criteria for MTM services) started out as a display measure out, and was so added to the Part D Star Ratings in 2016 equally a procedure measure.^eleven Using data from 2014 and 2015, the MTM plan comprehensive medication review completion rate for Medicare Advantage prescription drug plans and prescription drug plans were 30.9% and 15.iv%, respectively, for rating year 201618 and 45.half dozen% and 25.3%, respectively, for rating year 2017.^nineteen

CMS also adult new audit performance elements for MTM programs that were piloted in 2016 to monitor the compliance and quality of the MTM programme plan sponsor.¹¹ These audit elements evaluated the appropriateness of the plan sponsor'due south enrollment and disenrollment of eligible beneficiaries into their MTM programs, and whether beneficiaries were provided a comprehensive medication review and/or targeted medication review.²⁰

Starting in 2013, Part D programme sponsors were required to mail information nigh their MTM program on their Part D plan's website, including the plan'due south MTM eligibility requirements, whom to contact for more information, and a loftier-level summary of the services offered.²¹ Plan sponsors were besides encouraged to provide admission to a blank personal medication list.²¹

In 2014, the website requirements expanded to include a web page dedicated to the MTM plan with all the previous requirements, admission to a personal medication list, and a clarification of how a beneficiary is notified of the MTM program eligibility.²² CMS too suggested that the web page be accessible by 2 or fewer clicks from the sponsor's Medicare drug programme website.²²

Before long later on the 2014 requirements took consequence, merely 59.5% of a convenience sample of Part D plans were compliant with the elements of the guidance, including having a dedicated MTM plan web page that incorporates basic information about the program and its eligibility requirements, providing access to a blank personal medication list on the web folio, and making it easy to access the dedicated web page or the MTM program information.²³ A more recent evaluation of compliance with 2016 website requirements that used a random sample of 106 Function D plan contracts showed that only 51% were compliant.²⁴

Discussion

In 2008, the American Pharmacists Association and the National Association of Concatenation Drug Stores Foundation published Medication Therapy Management in Chemist's Practice: Cadre Elements of an MTM Service Model (version 2.0),²⁵ which is a model framework for implementing constructive MTM services. The services described in this model are dependent on interdisciplinary collaboration betwixt healthcare professionals to optimize medication use and embrace a patient-centered process of care.

This model framework identified the post-obit v core elements of MTM services delivery²⁵:

1. Medication therapy review
2. Personal medication record
3. Medication-related action programme
4. Intervention and/or referral
5. Documentation and follow-up.

All of these elements are institute in the current CMS requirements for Function D MTM programs, only initially CMS provided thin guidance on how Function D MTM program sponsors should pattern and implement their MTM programs.4 MTM services were non specified by CMS until 2010, with the inclusion of the comprehensive medication review, and in 2013, with the requirement that the Standardized Format exist used to provide a written summary of the comprehensive medication review to beneficiaries and/or to their caregivers.^five,8

At that place has also been increasing guidance on how plans tin set eligibility criteria for their MTM services. Early in the MTM program, Part D sponsors' restrictive eligibility requirements resulted in just 11% of Part D enrollees beingness eligible for MTM services in 2008.²⁶ To increment enrollment eligibility, CMS set maximum thresholds for eligibility requirements in 2010 and reduced the eligibility threshold to $3000.^6,26 Based on an assay of prescription drug data, CMS predicted that approximately 25% of the Part D population would be eligible for MTM services in 2010, using these new requirements.²⁷ However, the lowered thresholds for eligibility were still unsuccessful in improving access to MTM services, with fewer than 8% of Part D enrollees being eligible in 2011.²⁷

The criteria that plan sponsors chose continued to be restrictive. In a study of 532 Medicare Part D contracts in 2012, variation in MTM enrollment existed across plan sponsors, ranging from 0.2% to 57.3%.²⁸ Plans that had more than restrictions had a lower enrollment rate; the enrollment charge per unit was 16.4% with contracts requiring 2 chronic atmospheric condition and 9.two% with contracts requiring 3 chronic atmospheric condition. One program targeted patients who had three of four diseases (asthma, chronic heart failure, rheumatoid arthritis, and schizophrenia), which take just a 0.1% gamble of occurring together.²⁸

The written report's researchers proposed that programme sponsors strategically decide the amount they are willing to pay for MTM services and develop eligibility criteria accordingly.²⁸ Another assay of MTM eligibility requirements and enrollment patterns showed that in the 2010 to 2014 fourth dimension frame, between fifty% and 80% of plans chose a minimum of 3 chronic diseases and/or a minimum of eight Part D drugs.²⁹

The MTM program criteria and the restrictiveness of the eligibility criteria might take been determined past financial considerations.²⁹ There are no specific funds directed toward paying for MTM programs, and there are no rewards for optimizing medication therapy in plans that provide only chemist's shop benefits and no medical benefits for their members. MTM programs are paid out of administrative funds equally a component of plan bids for a contract with CMS. These authoritative funds are to cover all costs of managing and administering the Part D program. To go along the costs low for the MTM programme, plans may limit the amount of resources allocated for the programs, resulting in restrictive criteria to minimize beneficiary eligibility. Remodeling the electric current budget to rely on funds specifically carved out for the MTM program, rather than administrative costs, may offer an opportunity to include more beneficiaries.²⁹

Prescription drug plans are stand-alone plans that are responsible for covering prescription drugs and are not at gamble for medical or overall healthcare costs; these plans are less incentivized to invest in MTM programs than plans that are at gamble for overall healthcare costs.³⁰ Most Medicare Advantage prescription drug plans are responsible for medical costs and prescription drug coverage, so they have a greater incentive to implement programs to lower overall costs. Simply approximately 33% of all Office D enrollees select Medicare Advantage prescription drug plans.³¹

The fundamental lessons learned with the Medicare Office D MTM program are:

1. Little guidance was provided to Part D plans on MTM plan design, which ultimately immune plans the freedom to select restrictive requirements
2. The lack of a financial incentive to enroll bene­ficiaries has contributed to restrictive eligibility ­requirements
3. Without benefit from improved medication utilization, Role D plans do not fully appoint beneficiaries in the MTM program.

More a decade of experience with the existing Medicare Part D MTM program has led to the recent evolution and implementation of the Part D ­Enhanced MTM model. Through the Heart for Medicare & Medicaid Innovation, a 5-year model plan was launched on January 1, 2017, with 6 participating Role D prescription drug plan sponsors.³² This model is testing whether providing Part D sponsors with boosted payment incentives and regulatory flexibilities would promote innovative MTM programs and lead to improved outcomes and reduced costs.³²

Participating prescription drug plans are offered a operation-based payment if their enrolled members' medical expenses (Medicare Part A and Part B costs) "are reduced past at least 2 pct in a given plan year compared to a benchmark that faux their functioning if they were not in the model."³³ Through this model, Part D sponsors have the autonomy to vary the intensity and type of MTM services provided based on beneficiary risk level, and they may leverage their own core competencies to accomplish these goals.³²

The performance-based results of the Enhanced MTM model in 2017 were released on November 30, 2018.³³ The one.7 meg beneficiaries enrolled in the participating plans spent approximately $325 one thousand thousand less than the anticipated spending benchmark. Plan enrollment and savings were expected to increment during 2018.^{3 3}

While we expect boosted details on the value of dissimilar approaches to MTM programme design and implementation from the Enhanced MTM model, CMS and the Academy of Managed Intendance Pharmacy (AMCP) refer to MTM programme resources, such as Medication Therapy Direction in Pharmacy Practice: Core Elements of an MTM Service Model (version ii.0), the Agency for Healthcare Research and Quality systematic review, the Patient-Centered Medical Domicile: Integrating Comprehensive Medication Management to Optimize Patient Outcomes Resources Guide, and the Pharmacists' Patient Care Process.^34,35 Much of the current MTM program design and implementation have been based on these resource along with discussions with MTM providers and Office D programme sponsors, and on data assay of Function D prescription claims and MTM program process measures.¹⁶

All the same, beneficiary-centered evaluations should likewise be encouraged to inform Part D MTM program requirements. For example, the Standardized Format is not ever utilized every bit information technology was intended. In a survey of Medicare beneficiaries who had received a comprehensive medication review, 33% could not remember receiving the Standardized Format.³⁶ In that study, 67% of beneficiaries created their own smaller versions of the medication list instead of using the personal medication list in the Standardized Format.³⁷ A focus group of Medicare beneficiaries, caregivers, and case managers identified similar preferences for a more concise Standardized Format that could be shared with the unabridged healthcare team.³⁷

Another report, the largest national survey to date of Medicare beneficiaries who had received a comprehensive medication review, showed that less than l% of survey respondents perceived the Standardized Format as good or excellent in helping them to manage their medications.³⁸ The AMCP included the results of this national survey in comments to the 2020 CMS Call Letter, noting that beneficiary-focused modifications could consequence in improved utilize of the Standardized Format.³⁹

Additional work to appoint this grouping of stakeholders (ie, Medicare beneficiaries and their caregivers) as report participants, equally well as codesigners of the Part D MTM programme, volition likely yield greater beneficiary engagement and beneficiary-centered outcomes.

Conclusion

When faced with data showing low enrollment rates in the Medicare Role D MTM programme that resulted from restrictive criteria set by health plans, CMS inverse its requirements to expand the eligible beneficiary puddle for MTM services. Despite these changes, MTM services are nonetheless poorly utilized. The Enhanced MTM model with regulatory flexibility and financial incentives will provide additional guidance on opportunities to improve the MTM program. Beneficiary-centered evaluations should also be encouraged to inform Part D MTM programme requirements.

Every bit new models of intendance delivery focusing on Medicare beneficiaries evolve, it is critical to integrate the lessons learned from the MTM program to highlight the importance of information substitution and codesign, which may help to identify what matters about to Medicare beneficiaries.

Acknowledgments

We are grateful to Brian J. Isetts, PhD, BCPS, FAPhA, Professor, Department of Pharmaceutical Care and Wellness Systems, University of Minnesota, College of Pharmacy, for his extensive review of the manuscript and dedication to the importance of this work.

Author Disclosure Statement

Dr Gray, Dr Cooke, and Dr Brandt have no conflicts of involvement to study.

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