Implications of the CMMI Enhanced Medication Therapy Management Program for the Future of Community Pharmacy

Review of the Current CMS Part D MTM Program

In 2006, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) was implemented, marking the launch of medication therapy management (MTM) services under Medicare Part D. The inclusion of MTM, as part of the Part D drug benefit, was intended to “improve medication use” and “reduce the risk of adverse drug events” among targeted beneficiaries.¹ Criteria for targeting beneficiaries for MTM are determined by the individual Part D plan (PDP) in alignment with requirements set forth by the Centers for Medicare and Medicaid Services (CMS). At that time, CMS purposefully left these criteria broad; PDPs were instructed to target, at minimum, patients with “multiple chronic conditions,” taking “multiple Part D medications,” and with a projected annual Part D drug spend of at least $4000. Further definitions for the former were not provided. The rationale of CMS was that, while reasonable additional criteria existed at the time, more research and the emergence of industry standards should preface further regulatory requirements. Moreover, CMS did not require a specific MTM service model to be employed by PDPs and funding for the programs was considered an administrative cost (ie, part of a PDP’s bid).¹ Numerous models emerged as a result, such as use of telephonic MTM via plan-administered call centers, contracts with networks of community pharmacies for face-to-face medication reviews, and direct beneficiary mailings of educational pamphlets.²

Over the next decade, CMS made changes to the Part D MTM requirements in acknowledgement of the emergence of new information and guidance documents, as well as the need for quality improvement to improve MTM outcomes. With regard to service model requirements, in 2010, CMS guidance changed to require a minimum of an annual “person-to-person” comprehensive medication review (CMR) and quarterly targeted medication reviews (TMRs). This change prohibited the sole delivery of educational mailings as meeting the MTM requirement.³ In 2010, further specification on criteria for patient targeting was also provided. The requirement of “multiple Part D medications” was expanded to be defined as between 2 and 8 Part D medications (ie, a PDP may require no more than 8 medications as a minimum threshold for MTM eligibility). “Multiple chronic diseases” was defined as 2 or 3 diseases (ie, a PDP cannot require a patient to have more than 3 chronic diseases to be eligible for their MTM program). CMS permits PDPs to include any chronic disease or to target specific chronic diseases of which patients must have 2 to 3 in order to qualify.³ However, if PDPs choose the latter approach, they must choose to target at least 5 diseases from the following list of 9 core chronic diseases:

• Alzheimer’s disease
• Chronic heart failure
• Diabetes
• Dyslipidemia
• End-stage renal disease
• Hypertension
• Respiratory disease (eg, asthma)
• Bone disease (eg, arthritis)
• Mental health diseases (eg, depression)

Most recently, in 2013, CMS implemented the requirement of a written summary of the CMR using a standardized format. This applies to the creation of a cover letter, a personal medication list, and a medication action plan. The standardized format is available in both English and Spanish.⁴

Currently, Part D MTM programs remain part of the PDP’s administrative costs, and beneficiary eligibility continues to be based on the number of medications, chronic diseases, and projected Part D drug spend.⁵ The majority (76%) of PDPs do not target beneficiaries beyond those meeting the minimum CMS criteria. Moreover, 82% of PDPs target beneficiaries with at least 3 chronic diseases, and 97% are targeting specific chronic diseases. The most commonly targeted diseases are diabetes, chronic heart failure, and dyslipidemia. Over half (56%) of PDPs requires that the beneficiary be taking 8 Part D medications, and 72% require that the medications be for chronic diseases.⁶ For 2016, the drug-spend threshold has been set at $3507. Eligible beneficiaries, those meeting all 3 of the CMS criteria, must be offered an annual CMR and quarterly TMRs. CMR documentation must follow the CMS standardized format.⁵

Overview of Enhanced MTM Model

Since its inception, numerous challenges with the Part D MTM program have been identified. Some examples include poor patient engagement,^7,8 inconsistencies in outcomes data and the need for standardized quality measures,^8,9 and concerns with eligibility criteria, particularly as they relate to racial and ethnic disparities.¹⁰ Many of the challenges observed can be related back to how program financing was initially conceptualized and structured. Given that PDPs must finance their programs, as part of their administrative costs, there must be sufficient financial incentive for PDPs to design robust programs reasonably expected to achieve the original goals of MTM by inclusion in passage of the MMA. Yet for standalone PDPs (ie, those not responsible for costs beyond Part D prescription drugs), this incentive is not present, as the financial benefits of MTM are expected to be much greater for medical, rather than drug, costs. Several approaches to aligning financial incentives have been suggested previously.⁷

In September 2015, in recognition of these financial barriers, CMS announced plans for the Part D Enhanced MTM Model.¹¹ This pilot test is being conducted through the Center for Medicare and Medicaid Innovation (CMMI). The Model is scheduled to launch January 1, 2017, for 5 performance years. Standalone PDPs, with at least 3 stars, 2000 enrollees, and a history of 3 years or more, prior to the Enhanced Model, will be able to apply for participation. Five Part D regions will be included in the Model: Region 7 (Virginia), Region 11 (Florida), Region 21 (Louisiana), Region 25 (Iowa, Minnesota, Montana, Nebraska, North Dakota, South Dakota, Wyoming), and Region 28 (Arizona). If a participating PDP enrolls beneficiaries in more than one of these regions, the Enhanced Model must be used in all regions.¹²

In the Enhanced Model, PDPs may choose any eligibility criteria they feel are appropriate in targeting beneficiaries for MTM. Furthermore, rather than requiring all eligible patients to be offered the same MTM service package, PDPs may tailor MTM services to address different levels of risk for medication-related problems. Two new payment mechanisms will be implemented to improve the financial incentive for participating plans. First, participating PDPs will receive a prospective per-member-per-month (PMPM) payment to fund provided MTM services. Second, a $2.00 PMPM performance-based incentive payment will be provided in the form of an increase in the government (vs beneficiary) contribution to plan premiums. Performance-based payments will begin in Year 3 (ie, the results of Year 1 will determine payments in Year 3; Year 2 results will determine payments in Year 4, etc).¹²

Implications of Enhanced MTM for Community Pharmacy

The Medicare Part D Enhanced MTM Model has the potential to impact community pharmacists and the future of community pharmacy practice, in a number of ways. Some examples are described below.

Changes in Patient Volume, Service Packages, and Compensation

Currently, there may be limited opportunities for community pharmacists to provide MTM through contracts with PDPs. The most common mechanism by which community pharmacists provide these services is through community pharmacy contracts with MTM vendor companies. On one side, MTM vendors contract with PDPs to administer their MTM program, and on the other side, they contract with a network of community pharmacies to provide the MTM services. However, in 2015, only 28% of PDPs elected to incorporate this model into their MTM programs.⁶ Moreover, the volume of patients eligible at a given pharmacy location, as well as the compensation rates for services, can serve as a barrier to full engagement of community pharmacies, as the costs of service delivery and challenges of workflow redesign may not be financially feasible when weighing the business opportunities presented. The announcement of the Enhanced MTM Model, released in September 2015, and the final Request for Applications from PDPs, make numerous references to the potential for increased engagement by community pharmacists in MTM through various contracts.^11,12 Consequently, there is potential for PDP engagement in MTM models using local community pharmacists to increase significantly, thus increasing the volume of patients eligible to be served by these pharmacists, which would reduce one barrier to an engagement.

The Model’s inclusion of performance-based payments, through increased government contribution to plan premiums,¹² as a financial incentive to participating PDPs is also notable. Similarly, the MTM program CMR completion rate will be added as a Star Rating process measure in 2016.⁶ Although Star Ratings are assigned to PDPs, not pharmacies, these initiatives may result in a greater emphasis, in future years, on developing contracting relationships that financially reward community pharmacies that assist PDPs in achieving better CMR completion rates and/or patient outcomes.

Furthermore, the specific services that community pharmacists are contracted to provide (either directly with the PDP or by an MTM vendor) could differ significantly from what is currently required. The Enhanced MTM model emphasizes a personalized approach to MTM with PDPs tailoring interventions to beneficiary needs and/or medication risk levels.^11,12 Therefore, contracted pharmacies may be required to provide a wide range of service “packages.” For example, for some beneficiaries, PDPs may place a greater emphasis on TMR provision and require the pharmacist to complete several TMRs, rather than an annual CMR. Other PDPs may choose to increase the frequency of CMRs (eg, to require quarterly CMRs for patients taking certain medications or with certain disease states). The PDP’s MTM intervention design may also change the venue where the pharmacist provides care. Although community pharmacists are accustomed to providing MTM in private and/or semiprivate consultation areas at their pharmacies, those contracted for Enhanced MTM Model beneficiaries may be required to provide MTM in other locations, such as the patient’s primary care provider’s office or the patient’s home. Depending on the approach taken by the PDP, service model features could influence education and training required of participating pharmacists. Finally, as the Enhanced MTM Model permits PDPs to pilot novel documentation approaches,^11,12 contracted community pharmacists may be required to learn and use different documentation formats than the standardized and/or other formats being used for other payers.

Participation in the Identification of Eligible Beneficiaries and Program Marketing

In the current model, community pharmacists are not routinely involved in the identification of eligible patients for Part D MTM services. The screening of a PDP’s beneficiary list for eligibility is either conducted by the PDP itself or by its contracted MTM vendor. Eligible patients are referred directly to a contracted pharmacy, which is then responsible for contacting the patient to schedule the CMR, or for conducting a TMR, as applicable. The Enhanced MTM Model guidance describes community pharmacist identification of eligible patients as one strategy that participating PDPs may consider, as these pharmacists are familiar with their patients.^11,12 PDPs could also develop mechanisms by which pharmacists and/or prescribers could identify patients appropriate for MTM who do not fit into the PDP’s other eligibility criteria. These types of approaches have been used by other MTM payers, including the Wisconsin Pharmacy Quality Collaborative and the Iowa Medicaid Pharmaceutical Case Management Program.^13,14 Incorporating these strategies into novel MTM programs could position community pharmacists to assist in achieving better MTM outcomes by focusing their efforts on those most likely to benefit.

Moreover, less than desirable engagement of eligible patients in MTM services has been described; it is estimated that only approximately 10% of beneficiaries eligible for MTM under their PDP actually accept the offer and receive a CMR.^7,8 Perhaps with this in mind, CMS indicates that it “…expect[s] sponsors to rely more heavily on more personalized strategies, such as contacts from trusted community pharmacists or their medical providers, because for certain populations these may be more effective than call-center or mail contacts from the PDP.”¹² Clearly, improving beneficiary engagement is important to Part D stakeholders, and this verbiage from CMS indicates that community pharmacists will likely be further recognized as medication experts and patient advocates.

Participating in MTM Referrals from Prescribers

Improved care coordination and enhanced relationships among MTM stakeholders, including prescribers, is emphasized by the Enhanced MTM Model. Proposed strategies for achieving these improvements include enabling physicians to refer patients for MTM via streamlined communication mechanisms, including in advance of medical appointments.^11,12 Numerous opportunities exist for community pharmacists to assist physicians by recommending criteria prescribers could consider in making MTM referrals, designing the referral process, educating patients about the rationale for referral, and working together to develop strategies for medication recommendations most likely to be valued and accepted by prescribers. Relationships among community pharmacists and physicians, and the value placed by a typical physician on the role of community pharmacists in patient care could be greatly improved as a result, along with subsequent impacts on care coordination and patient outcomes.

Interface of MTM with other Community Pharmacy Services

The Enhanced MTM Model suggests that PDPs, participating in the pilot, may choose to provide additional interventions, such as value-added products and services, to complement their MTM program. Examples include adherence packaging and medication synchronization, among others.^11,12 Clearly, if PDPs choose to incorporate these additional interventions into their Enhanced MTM programs, community pharmacists will be well positioned to further build relationships with their patients and test workflow strategies that streamline the combination of different pharmacy services. These extra interventions could also provide further revenue streams for the pharmacy that do not exist under current Part D MTM models.

Data Exchange and Medical Data Availability to Community Pharmacists

Poor care coordination is a widely recognized problem in US health care, and community pharmacists often report challenges associated with having insufficient access to patient information outside their own organization’s dispensing records. Two aspects of the Enhanced MTM Model may help to address these challenges in the future. First, PDPs participating in the Enhanced MTM Model may request access to beneficiaries’ Part A and B claims data. The intent of CMS in permitting this data sharing is to enable a “greater context for each beneficiary’s medication regimen.”¹² This could present opportunities for the PDP to share these data with contracted community pharmacists for use during MTM consultations, which could strengthen the pharmacist’s ability to accurately identify medication-related problems and make meaningful recommendations to prescribers. Second, the Model guidance notes that participating plans “may establish processes for electronic exchange of interoperable MTM documentation that integrate conveniently into prescriber workflows.”¹² Collectively, relationships among patients, pharmacists, and prescribers would be expected to further improve in the long term with this level of coordination, with the potential for significant positive impacts on therapeutic outcomes and patient safety.

MTM Metrics and Program Evaluation

Robust evaluation of the Enhanced Model is planned and will involve the creation of new MTM metrics.¹² This may result in community pharmacists noticing changes in data elements required by participating PDPs for documentation of MTM services provided. The results of this program evaluation have a high potential to shape future community pharmacy practice by enabling MTM stakeholders to better optimize patient eligibility criteria and approaches for tailoring service delivery, as well as strategies for promoting patient and provider engagement.

This article is published in collaboration with the Directions in Pharmacy CE Conference program.

Margie E. Snyder, PharmD, MPH, is associate professor of pharmacy practice at Purdue University College of Pharmacy.

References

• CMS Medicare Part D Final Rule. Federal Register. Vol. 70, No 18. gpo.gov/fdsys/pkg/FR-2005-01-28/pdf/05-1321.pdf. Published January 28, 2005. Accessed January 7, 2016.
• CMS. Medicare Part D medication therapy management programs: 2009 fact sheet. cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/MTM.html. Published July 21, 2009. Accessed January 7, 2016.
• CMS. 2010 Medicare Part D medication therapy management programs: fact sheet. cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/MTM.html. Published June 8, 2010. Accessed January 7, 2016.
• CMS. 2013 Medicare Part D medication therapy management programs fact sheet. cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/CY2013-MTM-Fact-Sheet.pdf. Published September 12, 2013. Accessed January 7, 2016.
• CMS. CY 2016 medication therapy management guidance and submission instructions. cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/Memo-Contract-Year-2016-Medication-Therapy-Management-MTM-Program-Submission-v-040715.pdf. Accessed Published April 7, 2015. January 7, 2016.
• CMS. 2015 Medicare Part D medication therapy management programs fact sheet. cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/CY2015-MTM-Fact-Sheet.pdf. Published August 21, 2015. Accessed January 7, 2016.
• Rucker NL. Medicare Part D’s medication therapy management: shifting from neutral to drive. aarp.org/content/dam/aarp/research/public_policy_institute/health/medicare-part-d-shifting-from-neutral-to-drive-insight-AARP-ppi-health.pdf. Accessed January 7, 2016.
• Acumen. Medication therapy management in chronically ill populations: final report. innovation.cms.gov/Files/reports/MTM_Final_Report.pdf. Published August 2013. Accessed January 7, 2016.
• Viswanathan M, Kahwati LC, Golin CE, et al. Medication therapy management interventions in outpatient settings: a systematic review and meta-analysis. JAMA Intern Med. 2015;175(1):76-87. doi: 10.1001/jamainternmed.2014.5841.
• Wang J, Mullins CD, Brown LM, et al. Disparity implications of Medicare eligibility criteria for medication therapy management services. Health Serv Res. 2010;45(4):1061-1082. doi: 10.1111/j.1475-6773.2010.01118.x.
• CMS. Announcement of Part D Enhanced Medication Therapy Management Model test. innovation.cms.gov/Files/x/mtm-announcement.pdf. Published September 28, 2015. Accessed January 7, 2016.
• CMS CMMI. Medicare Part D Enhanced Medication Therapy Management Model. Request for applications. innovation.cms.gov/Files/x/mtm-rfa.pdf. Accessed January 7, 2016.
• Wisconsin Pharmacy Quality Collaborative Medication Therapy Management Services Program. pswi.org/Portals/17/WPQC/Wisconsin%20Pharmacy%20Quality%20Collaborative%20Medication%20Therapy%20Management%20Services%20Program.pdf. Accessed January 7, 2016.
• Iowa Medicaid pharmaceutical case management. www.iarx.org/files/1-Iowa%20PCM-ready.pdf. Accessed January 7, 2016.