in Practice

A New Ballgame: Comprehensive Medication Review It has been one year—since January 1, 2013—that comprehensive medication review has been recognized as a medication therapy management (MTM) service that must be offered annually by Medicare Part D prescription drug plans to “qualified beneficiaries.” This requirement solidifies the Centers for Medicare & Medicaid Services’ commitment to ensure all beneficiaries, including those in long-term care facilities, receive quality MTM services. Consultant pharmacists, who have long provided federally mandated medication regimen review services, may have their first opportunity to be paid for the additional services that they provide to individual Medicare beneficiaries residing in those facilities. Key Words: Centers for Medicare & Medicaid Services, Comprehensive medication review, Medication action plan, Medication regimen review, Medication therapy management, Personal medication list, Targeted medication review. Abbreviations: CMR = Comprehensive medication review, CMS = Centers for Medicare & Medicaid Services, MAP = Medication action plan, MRR = Medication regimen review, MTM = Medication therapy management, PML = Personal medication list, TMR = Targeted medication review.

Carla McSpadden

Introduction

S

ince the beginning of the Medicare Part D program in 2006, pharmacists have been waiting for the promised opportunity to be paid for the clinical services they provide to Medicare beneficiaries. Unfortunately for pharmacists, when the Part D medication program was launched by the Centers for Medicare & Medicaid Services (CMS), the agency needed to get the program up and running. Therefore, its focus was not on requiring or creating a robust medication therapy management (MTM) program to provide clinical services and medication review

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for all beneficiaries. Instead, it directed its regulations for MTM services only to “targeted beneficiaries,” which it defined as those who: 1) Have recognized multiple chronic conditions 2) Take multiple medications 3) Have high drug costs (defined as annual drug costs of $3,144 in 2013)1 As the Part D program has matured, however, CMS has put more attention on expanding MTM services, raising the bar on the minimum services and features of each Part D plan’s MTM program. In 2010, CMS specified a minimum number of elements that must be included in the MTM service, and defined that service as a

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“comprehensive medication review” (CMR).1 In 2013, the program evolved even further: CMS said that it expected plans that contracted with CMS to provide Part D services to “actively engage beneficiaries” to increase the number of CMRs delivered to enrollees, not just to “offer” them. And the program took yet another large step—CMR must be offered not only to qualifying beneficiaries in the community, but also to those in long-term care facilities.

What Is a “Comprehensive Medication Review”? Within the broad umbrella of MTM clinical services, CMS requires Part D plans to offer CMR to Medicare beneficiaries. In fact, Part D plans must offer a minimum level of services, including two kinds of reviews: • CMR, an annual, comprehensive, real-time, interactive medication review. It must include consultation with the beneficiary to assess overall individual medication use for the presence of medication-related problems. • Targeted medication review (TMR), a quarterly targeted medication review focusing on specific actual or potential medication-related problems. There should be follow-up interventions when necessary, for both beneficiaries and prescribers.1 CMS adapted its definition of a CMR from the “National MTM Advisory Board and the Core Elements of an MTM Service,” published by the American Pharmacists Association (APhA) and the National Association of Chain Drug Stores (NACDS) (see Resources, page 83). Therefore, the definition was developed by, and is generally accepted by, the industry. The definitions will not come as a surprise to most pharmacists since they outline the basic elements of any medication-related clinical service provided by a pharmacist. CMS says specifically the Part D CMR should meet the following criteria: • A systematic process that includes: • Collecting patient-specific information • Assessing medication therapies to identify medication-related problems • Developing a prioritized list of medication related problems • Creating a plan to resolve them with the patient, caregiver, and/or prescriber

• An interactive person-to-person or telehealth medication review and consultation conducted in real-time between the patient and/or other authorized individual (e.g., prescriber, caregiver) and the pharmacist or other qualified provider • A service designed to improve patients’ knowledge of their prescriptions and other treatments, identify and address problems or concerns that patients may have, and empower patients to self-manage their medications and health conditions2 Of interest, the person providing MTM services is not required to be a pharmacist. CMS has continued to let Part D plans have the flexibility to use other individuals to provide these services. In some plans, pharmacists are used; in other plans, they are used not at all or only for complex cases. However, CMS provided specific recommendations regarding the use of a pharmacist in providing the MTM services to long-term care beneficiaries. Part D plans should offer to provide a CMR to newly targeted beneficiaries who were not enrolled in the MTM program during the previous year, as soon as possible after enrollment into the MTM program.

As the Part D program has matured, CMS raised the bar on the minimum medication review services and features required of Part D plans. Beneficiaries who qualify for MTM services based on their number of chronic conditions, number of medications, and Part D drug costs are automatically enrolled in the MTM program by the Part D drug program. (However, a beneficiary may refuse or decline individual services without having to disenroll from the program entirely.) If an enrolled beneficiary declines the annual CMR, the plan is still required to offer interventions to the prescriber and attempt to perform the TMR quarterly review of an individual beneficiary’s specific or potential medicationrelated problems.

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A New Ballgame: Comprehensive Medication Review

Glossary

Comprehensive Medication Review: A specific term that falls under the medication therapy management umbrella and describes the annual, comprehensive, real-time, interactive medication review for eligible Medicare Part D beneficiaries. It must actively involve the beneficiary and be a comprehensive review of all of a beneficiary’s medications, including over-the-counter medications, herbal therapies, and dietary supplements. It is intended to aid in assessing medication therapy and optimizing patient outcomes and requires the provider to follow set documentation standards. Originally offered to beneficiaries in the community, since January 2013, it also applies to Medicare Part D beneficiaries residing in long-term care facilities. It can be provided by qualified nurses and other clinicians as well as pharmacists. Medicare Part D: Federal program covering drug costs for disabled and senior beneficiaries. Medication Regimen Review (MRR): Federally mandated medication review for each resident in a nursing facility at least monthly, with interim reviews for short-stay patients or residents experiencing an acute change in condition. Pharmacists must report any irregularities to the attending physician and the facility’s director of nursing. Medication Therapy Management Services (MTM): An umbrella term for a comprehensive approach to assess medication therapy, improve medication use, reduce the risk of adverse events, and improve medication adherence provided. It is a service provided to qualifying beneficiaries under Medicare Part D’s drug program. MTM was originally offered to certain eligible individuals with multiple conditions, taking multiple Part D medications, and those incurring set annual drug costs. Since January 2013, it must be offered to all qualifying beneficiaries, including those in long-term care facilities. Targeted Medication Review (TMR): A quarterly, targeted medication review focusing on specific actual or potential medication-related problems for eligible Medicare Part D beneficiaries.

Cognitively Impaired Beneficiaries CMS expects Part D plans to put in safeguards against discrimination of beneficiaries to ensure all those who meet the qualifying criteria are accommodated and offered MTM services, regardless of their cognitive status and residential setting. For beneficiaries with cognitive impairment who cannot make their own health care decisions, CMS says the pharmacist (or other qualified individual providing the MTM service) should coordinate with the beneficiary’s

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prescriber, caregiver, or other authorized individual, such as a health care proxy or legal guardian who would be involved in the process on behalf of the beneficiary. There are several related issues that CMS has not addressed. First, the agency provided no definition of cognitive impairment; therefore, Part D plans must set the criteria for identifying these beneficiaries. Second, CMS does not specifically mention whether employees of nursing facilities or assisted living communities can act as the beneficiary’s representative for CMR activities and did not

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Something to Talk About: Assessing and Addressing Elders’ Health Literacy

clarify who that representative could be other than a prescriber, caregiver, or authorized representative. However, Part D plans must provide to CMS the rationale behind their screening process for identifying beneficiaries with cognitive impairment and document the pertinent information about the representative for each cognitively impaired enrollee. Pharmacists involved in providing MTM services may be asked to participate in the assessment process to identify such beneficiaries. In fact, CMS suggested that Part D plans coordinate with long-term care consultant pharmacists who are already providing the legally required, monthly medication regimen review (MRR) and other pharmacy-related services to long-term care facilities (see box, right). Part D plans could require consultant pharmacists to conduct a cognitive assessment, either on their own or in coordination with other health professionals. Pharmacists involved in MTM activities should be prepared to use multiple engagement and communication methods to ensure information is relayed effectively to a variety of representatives (i.e., family member, prescriber). Pharmacists will also need a method of documenting— either maintaining within their own records or retrieving from the Part D plans—the results of their assessments, beneficiaries’ current cognitive status with the plans, and information about the beneficiary’s representative.

A Huge Step: CMR Required for Long-Term Care Beneficiaries In a major policy development, which started on January 1, 2013, Part D plans must offer a CMR to all beneficiaries enrolled in the MTM program—including those in long-term care facilities. The biggest questions consultant pharmacists face are these: • Who will the Part D plans use to provide MTM services to long-term care beneficiaries? • Will there be an opportunity for consultant pharmacists who are already providing MRR and other pharmacy-related services to the facilities where these beneficiaries reside? • And if so, how will that work?

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Medicare Part D’s MTM vs. State Operations Manual’s MRR Pharmacists have been providing review of medications for patients in nursing facilities, now known as medication regimen review (MRR), since it was mandated in 1974. Medication therapy management (MTM), begun in 2006 with the initiation of Medicare Part D and expanded since then, is a clinical service that qualifying Medicare Part D beneficiaries must receive. Although the review of medications may seem similar, there are many differences. Similarities • Involves evaluation of medication regimens • Common goals regarding quality and safety • Mandated by federal regulations with oversight by the Centers for Medicare & Medicaid Services (CMS) • Focused on older adult population Differences • Audience/recipient • MTM: Patient and prescriber • MRR: Facility and prescriber • Patient population • MTM: Medicare beneficiaries with multiple medications, chronic diseases, and a large total spent on medications • MRR: All residents in Medicare-certified nursing facilities • Criteria for eligibility • MTM: Specific criteria set by CMS and the Part D plan • MRR: No criteria; every resident must receive review • Federal regulations • MTM: CMS, under Medicare Part D • MRR: CMS, under Medicare provider Survey & Certification • Frequency of review • MTM: Annual comprehensive medication review (CMR) and quarterly targeted medication review (TMR) • MRR: Monthly review; more frequent reviews, if needed • Pharmacist involvement • MTM: Medication reviews may be conducted by pharmacist or other qualified professional • MRR: Medication reviews must be conducted by a pharmacist

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A New Ballgame: Comprehensive Medication Review

CMS has offered some guidance to Part D plans, but the plans are not necessarily required to follow their guidance. Nevertheless, CMS does offer some insight into how Part D plans may design their program for this population of MTM enrollees. CMS told Part D plans that they can use in-house resources (e.g., pharmacists or other qualified health care providers employed by their company) or make arrangements with other resources (e.g., pharmacy benefit managers, MTM vendors, or individual pharmacists, or other qualified providers) to provide MTM services and/or administer their MTM program. CMS also said that consultant pharmacists may be a resource for the delivery of CMRs to beneficiaries and that Part D plans should consider making arrangements with them to provide these services. Such arrangements could include direct contracts between the Part D plan and consultant pharmacists (or their intermediaries) or indirect contracts between the sponsor’s MTM vendor or pharmacy benefit managers and long-term care consultant pharmacists (or their intermediaries). CMS also addressed the potential overlap between the requisite monthly MRR and the newly required CMRs. The agency recognizes that these concomitant activities could possibly result in conflicting recommendations, but it offered no potential solutions. This will be left to the Part D plans and long-term care consultant pharmacists to work out.

Standardized Format for MTM Documents Starting in 2013, CMS requires providers of MTM services in the Part D plan to provide beneficiaries an individualized, written summary of their MTM services in a standardized format. This applies whether the CMR is provided to the beneficiary or to the beneficiary’s prescriber, caregiver, or other authorized representative. The purpose of providing these documents is to aid assessment of a beneficiary’s medication therapy and engage the beneficiary in managing his or her own drug therapy. Standardizing the format of these documents is expected to improve the quality of the MTM program services and provide consistency in beneficiary communications across differing Medicare Part D programs.

Three Documents Required The three MTM-related documents to be provided by the Part D plan to the beneficiary include: • Cover Letter: Letter to the beneficiary that reminds him or her of what occurred during the CMR, introduces the medication action plan (MAP) and personal medication list (PML), and describes how the beneficiary can contact the MTM program. • MAP: An outline that describes the specific action items resulting from the interactive CMR consultation and the beneficiary’s responsibilities. (MAP should not include detailed action plans of the MTM provider and is not intended to be a template for communications with other health care providers.) • PML: Reconciled list of all the medications in use (i.e., active medications) by the beneficiary at the time of a CMR. This list must be completed and updated with information provided by the beneficiary and/or caregiver during the consultation. Part D plans must also collect and report the purpose and instructions for the beneficiary’s use of each medication. The beneficiary and/or MTM provider should add new medications and their start dates and cross out discontinued products while indicating the stop dates and reasons for stopping. While the Part D plan is ultimately responsible for providing these standardized documents to the beneficiary, the MTM provider—potentially the consultant pharmacist— may be involved in compiling some or all of the content for the MAP and updating the PML. The exact responsibilities should be outlined in the MTM provider contract, and if they are not specified, pharmacists should ask the Part D plan to provide documentation responsibilities.

In January 2013, the program took another large step—a comprehensive medication review must be offered to qualifying beneficiaries in long-term care facilities.

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Resources • “Comprehensive Medication Reviews (CMRs) and Pharmacists’ Future in the Continuum of Care.” ASCP

educational program https://education.ascp.com/cmrworkshoparchived/CMR on how to conduct CMRs. • Gruber J. Medication therapy management: challenge for pharmacists. Consult Pharm 2012;27:782-96. • Martin CM, McSpadden CS. Dispelling the myths about medication therapy management services. Consult Pharm 2008;23:866-73. • Medication therapy management in pharmacy practice: core elements of an MTM service model (version 2.0). J Am Pharm Assoc 2008:341-53.

A Long-Awaited Opportunity While contracts with the Part D plans will provide the specific details of these expanded MTM requirements, the message is this: Consultant pharmacists may have a new opportunity to be paid for additional services to Medicare beneficiaries in the community as well as those residing in nursing facilities. This gives consultant pharmacists who provide CMR in nursing facilities a long-desired opportunity to provide—and be reimbursed for—the additional patient-centered care for facility residents. n Carla McSpadden, RPh, CGP, is a pharmacist in Paoli, Indiana. Disclosure: No funding was received for the development of this manuscript. The author has no potential conflicts of interest.

References 1. Centers for Medicare & Medicaid Services (CMS). Medicare Part D Medication Therapy Management Program Standardized Format. August 15, 2012. Accessed February 15, 2013. Available at https://www.cms.gov/Medicare/Prescription-Drug-Coverage/ PrescriptionDrugCovContra/Downloads/MTM-ProgramStandardized-Format-English-and-Spanish-Instructions-Samples-.pdf. 2. Centers for Medicare & Medicaid Services (CMS). CY 2013 Medication Therapy Management Program Guidance and Submission Instructions. April 10, 2012. Accessed February 15, 2013. Available at http://www.cms.gov/Medicare/Prescription-Drug-Coverage/ PrescriptionDrugCovGenIn/Downloads/Memo-ContractYear-2013-Medication-Therapy-Management-MTM-ProgramSubmission-v041012.pdf. 3. Centers for Medicare & Medicaid Services. State Operations Manual, Appendix PP, Interpretive Guidelines for Long-Term Care Facilities. January 7, 2011. Accessed February 15, 2013. Available at http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/ downloads/som107ap_pp_guidelines_ltcf.pdf.

Consult Pharm 2014;29:76-83. © 2014 American Society of Consultant Pharmacists, Inc. All rights reserved. Doi:10.4140/TCP.n.2014.76

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A new ballgame: comprehensive medication review.

It has been one year--since January 1, 2013--that comprehensive medication review has been recognized as a medication therapy management (MTM) service...
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