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

On January 1, 2006, Medicare beneficiaries were first able to access the Part D benefit either through a Medicare Advantage prescription drug plan or a stand-alone prescription drug plan.¹ Along with providing prescription drug coverage, Medicare Part D sponsors were also required to offer a medication therapy management (MTM) program to eligible beneficiaries.² Through the MTM program, pharmacists or other qualified providers interact 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 Alliance, an organization 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 use, 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 program requirements over the years and the impact these changes have had on Medicare beneficiaries with the goal of informing future program enhancements.

Methods

In this review, we examined policy changes in the Medicare Part D MTM program based on information found 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 Part D MTM program fact sheets and call letters between 2006 and December 2018. The CMS MTM fact sheets provide annual reviews of the MTM program, whereas the call letters detail 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,” “change,” or “implications.” The PubMed and Google searches were initially performed in October 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 not publicly available. The most recent fact sheet for 2018 was published on August 20, 2018.¹³

Evolution of the MTM Program

The initial design of the Medicare Part D program required Medicare beneficiaries to meet 3 criteria to be eligible for the MTM services, including⁴:

1. Have multiple chronic diseases
2. Take multiple drugs covered by Medicare Part D
3. Be likely to incur annual costs for covered Part D drugs that exceed a predetermined level.

Several changes have been made to the initial Part D MTM program eligibility criteria (Table).^4,5,7,8 Since 2006, Part D plan sponsors were required to target beneficiaries who had multiple chronic diseases with a minimum specified threshold of 2 to 5 chronic diseases.⁴ 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 3 chronic diseases were required to qualify for Part D MTM services. In 2010, approximately 72% of Part D MTM programs required a minimum threshold of 3 chronic diseases compared with only 51% in 2008 (Figure 1).^4-13 Plan sponsors continue to set restrictive criteria, and in 2018, approximately 87% of plans still required a minimum of 3 chronic conditions; the 2019 program requirements for Part D MTM programs are unchanged from calendar years 2017 and 2018.^13,14

In 2008, CMS also set 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 8 covered drugs.⁵ In 2009, 28.5% of plans restricted enrollment to patients taking 8 or more Part D drugs,⁴ which increased to 66.4% in 2010 (Figure 2).^4-13 In every year since 2010, the majority of Part D plans have required the use of 8 Part D drugs for a beneficiary to meet program eligibility, with 71% of plans requiring 8 or more Part D drugs in 2018.¹³

In 2009, beneficiaries also had to be likely to incur an annual cost of at least $4000 for covered Part D drugs to be eligible for the MTM program.⁴ In 2010, the annual cost threshold was lowered from $4000 to $3000.⁵ In 2012, this threshold increased slightly from $3000 to $3100.²⁰ and has continued to increase annually by a specified annual percentage.⁷ The annual cost thresholds for 2018 and 2019 were $3967 and $4044, respectively.^13,14

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 basis 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.⁴ However, since 2010, CMS has only allowed an opt-out method.^5-13

Targeted Interventions

Initially, the Part D MTM program was designed to include any type or combination of MTM interventions (Table). Plan sponsors could decide whether services were provided to the beneficiary and/or the healthcare provider. Sponsors could provide MTM services via telephone, e-mail, mail, or any combination of these delivery vehicles. The most common MTM interventions reported by Part D plan sponsors for 2009 were medication reviews, refill reminders, intervention letters, educational newsletters, prescriber consultations, drug interaction screenings, case management, and a medication profile or list.⁴

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, it became mandatory to provide beneficiaries with a written summary of their comprehensive medication review in a specified document, which was named the Standardized Format.¹⁵

The Standardized Format provided a means to document expected content in a consistent form. Long-term care 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 also able to provide additional services beyond those required services, and 48.4% of MTM programs provided a general education newsletter to the beneficiary, 15.2% programs had a refill reminder, and 10.3% instituted a case-management referral.⁵

MTM Program Reporting

Before 2010, Part D plan sponsors were required to 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.¹⁶ Starting in 2008, specific information about services rendered at the beneficiary level were also required to be reported by sponsors.¹⁶

Starting in 2010, the reporting requirements expanded to include⁶:

• The percentage 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 best practices.

CMS publicly reports how well Part D drug plans perform on several categories, such as quality of care and customer service, using the Star Rating System.¹⁷ The MTM program completion rate 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, and was then added to the Part D Star Ratings in 2016 as a process measure.¹¹ Using data from 2014 and 2015, the MTM program comprehensive medication review completion rate for Medicare Advantage prescription drug plans and prescription drug plans were 30.9% and 15.4%, respectively, for rating year 201618 and 45.6% and 25.3%, respectively, for rating year 2017.¹⁹

CMS also developed new audit performance elements for MTM programs that were piloted in 2016 to monitor the compliance and quality of the MTM program plan sponsor.¹¹ These audit elements evaluated the appropriateness of the plan sponsor’s 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 plan sponsors were required to post information about their MTM program on their Part D plan’s website, including the plan’s MTM eligibility requirements, whom to contact for more information, and a high-level summary of the services offered.²¹ Plan sponsors were also encouraged to provide access to a blank personal medication list.²¹

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

Shortly after the 2014 requirements took effect, only 59.5% of a convenience sample of Part D plans were compliant with the elements of the guidance, including having a dedicated MTM program web page that incorporates basic information about the program and its eligibility requirements, providing access to a blank personal medication list on the web page, 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 Part D plan contracts showed that only 51% were compliant.²⁴

Discussion

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

This model framework identified the following 5 core elements of MTM services delivery²⁵:

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

All of these elements are found in the current CMS requirements for Part D MTM programs, but initially CMS provided sparse guidance on how Part D MTM plan sponsors should design and implement their MTM programs.4 MTM services were not specified by CMS until 2010, with the inclusion of the comprehensive medication review, and in 2013, with the requirement that the Standardized Format be used to provide a written summary of the comprehensive medication review to beneficiaries and/or to their caregivers.^5,8

There has also been increasing guidance on how plans can set eligibility criteria for their MTM services. Early in the MTM program, Part D sponsors’ restrictive eligibility requirements resulted in only 11% of Part D enrollees being eligible for MTM services in 2008.²⁶ To increase enrollment eligibility, CMS set maximum thresholds for eligibility requirements in 2010 and reduced the eligibility threshold to $3000.^6,26 Based on an analysis 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 restrictions had a lower enrollment rate; the enrollment rate was 16.4% with contracts requiring 2 chronic conditions and 9.2% with contracts requiring 3 chronic conditions. One plan targeted patients who had 3 of 4 diseases (asthma, chronic heart failure, rheumatoid arthritis, and schizophrenia), which have only a 0.1% chance of occurring together.²⁸

The study’s researchers proposed that plan sponsors strategically decide the amount they are willing to pay for MTM services and develop eligibility criteria accordingly.²⁸ Another analysis of MTM eligibility requirements and enrollment patterns showed that in the 2010 to 2014 time frame, between 50% and 80% of plans chose a minimum of 3 chronic diseases and/or a minimum of 8 Part D drugs.²⁹

The MTM program criteria and the restrictiveness of the eligibility criteria might have been determined by 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 pharmacy benefits and no medical benefits for their members. MTM programs are paid out of administrative funds as a component of plan bids for a contract with CMS. These administrative funds are to cover all costs of managing and administering the Part D plan. To keep the costs low for the MTM program, plans may limit the amount of resources allocated for the programs, resulting in restrictive criteria to minimize beneficiary eligibility. Remodeling the 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 risk for medical or overall healthcare costs; these plans are less incentivized to invest in MTM programs than plans that are at risk 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. Only approximately 33% of all Part D enrollees select Medicare Advantage prescription drug plans.³¹

The key lessons learned with the Medicare Part D MTM program are:

1. Little guidance was provided to Part D plans on MTM program design, which ultimately allowed 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, Part D plans do not fully engage beneficiaries in the MTM program.

More than a decade of experience with the existing Medicare Part D MTM program has led to the recent development and implementation of the Part D ­Enhanced MTM model. Through the Center for Medicare & Medicaid Innovation, a 5-year model program was launched on January 1, 2017, with 6 participating Part D prescription drug plan sponsors.³² This model is testing whether providing Part D sponsors with additional 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 performance-based payment if their enrolled members’ medical expenses (Medicare Part A and Part B costs) “are reduced by at least 2 percent in a given plan year compared to a benchmark that simulated their performance 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 1.7 million beneficiaries enrolled in the participating plans spent approximately $325 million less than the anticipated spending benchmark. Plan enrollment and savings were expected to increase during 2018.³³

While we await additional details on the value of different approaches to MTM program design and implementation from the Enhanced MTM model, CMS and the Academy of Managed Care Pharmacy (AMCP) refer to MTM program resources, such as Medication Therapy Management in Pharmacy Practice: Core Elements of an MTM Service Model (version 2.0), the Agency for Healthcare Research and Quality systematic review, the Patient-Centered Medical Home: Integrating Comprehensive Medication Management to Optimize Patient Outcomes Resource Guide, and the Pharmacists’ Patient Care Process.^34,35 Much of the current MTM program design and implementation have been based on these resources along with discussions with MTM providers and Part D plan sponsors, and on data analysis of Part D prescription claims and MTM program process measures.¹⁶

However, beneficiary-centered evaluations should also be encouraged to inform Part D MTM program requirements. For example, the Standardized Format is not always utilized as it 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 entire healthcare team.³⁷

Another study, the largest national survey to date of Medicare beneficiaries who had received a comprehensive medication review, showed that less than 50% 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 result in improved use of the Standardized Format.³⁹

Additional work to engage this group of stakeholders (ie, Medicare beneficiaries and their caregivers) as study participants, as well as codesigners of the Part D MTM program, will likely yield greater beneficiary engagement and beneficiary-centered outcomes.

Conclusion

When faced with data showing low enrollment rates in the Medicare Part D MTM program that resulted from restrictive criteria set by health plans, CMS changed its requirements to expand the eligible beneficiary pool for MTM services. Despite these changes, MTM services are still 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 program requirements.

As new models of care delivery focusing on Medicare beneficiaries evolve, it is critical to integrate the lessons learned from the MTM program to highlight the importance of information exchange and codesign, which may help to identify what matters most to Medicare beneficiaries.

Acknowledgments

We are grateful to Brian J. Isetts, PhD, BCPS, FAPhA, Professor, Department of Pharmaceutical Care and Health 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 interest to report.

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