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Introduction

If you are providing MTM services to patients enrolled in Medicare Part D, patients must meet specific selection criteria in order to have MTM services reimbursed by Medicare. However, many pharmacists who provide MTM are casting the net beyond Medicare Part D enrollees, to reach other groups of patients who can benefit from MTM services. This chapter analyzes both of those groups, to help pharmacists target the most appropriate patients for MTM services.

How patients are targeted for MTM depends much on the arrangements for reimbursement within the pharmacy setting. When a pharmacist provides MTM under Medicare Part D, the services must follow a particular protocol and may be constrained by limited reimbursement. Some pharmacy organizations provide MTM services for employers that are looking to reduce healthcare costs and absentee rates among their workforce. Research on these programs has shown that for every $1 spent on MTM, the employer can save between $6 and $12 on healthcare costs.^1,2 The Patient-Centered Medical Home (PCMH) is another example of a care structure with an emphasis on MTM.¹ In both of the latter scenarios, the criteria for patient selection tends to be much broader than that defined by Medicare Part D, as outlined in Table 1.

Table 1. Comparison of Patient Selection Criteria and MTM Structure, Medicare Part D and Non-Medicare
	Medicare Part D Patients	Non-Med D Patients
Age	Over 65 generally Medicare eligible*	Any Age
Referral Path	Referred through Medicare Part D sponsor to: Pharmacy benefit managers (PBMs) Contracted MTM provider (e.g., Mirixa) Contracted community provider *Long-term care residents are no longer exempt. CMS generally views long-term care residents as community dwellers. They are eligible for MTM in addition to the CMS-mandated monthly consultant pharmacist review.	Direct marketing Employer contracts PBMs for non-Med D insured Contracts with pharmacies Patient self-referral Physician referrals Pharmacy referrals (from non MTM providing pharmacies) Hospitals, care transition organizations, accountable care organization (ACO) affiliates, patient centered medical homes (PCMH).
Referral Criteria	Enrollees meeting specified targeting criteria per CMS requirements: Annual drug costs >$3,517 Minimum # drugs 2–8 Target disease states Multiple chronic diseases Expanded criteria: Enrollees meeting other plan-specific criteria (agreed upon at the sponsor's application to CMS and annual review)	Single chronic disease management Multiple chronic disease management Medication adherence issues Self-referral for any reason in self-refer model
Reimbursement	Use of CPT codes: 99605 99606 99607	Negotiated rates per contract with employee groups, or other groups Fee for service
MTM service	Must provide written summary in Comprehensive Medication Review (CMR) format: Cover letter Medication Action Plan (MAP) Personal Medical Record (PMR) Discuss concerns with drug therapy; summary of purpose and instructions for medications; review medications including non-Rx, supplements; engage beneficiaries in management of drug therapy. Core elements of MTM model May include other value added services; however, reimbursements may be a constraint.	CMS MTM CMR recommended (see left) Core elements of MTM model Added services may include: adherence support outside consultation with other healthcare providers continuity of care/care transition services provider protocols
Table provided courtesy of Demetra Antimisiaris, PharmD

Medicare Part D MTM Criteria

Medicare Part D "sponsors" (or payers) are private insurance companies that contract with Medicare to provide drug benefits to Part D enrollees.³ Sponsors may offer their own MTM services (often provided via phone), or they may contract with pharmacies or specialized MTM organizations to provide phone or in-person MTM services. If so, sponsors will refer candidates to the pharmacy setting for MTM, based on the Medicare Part D criteria outlined below.

For automatic enrollment (eligibility) in MTM based on Medicare Part D requirements, patient must meet all 3 criteria:⁴

1. Patient has multiple chronic diseases
   The sponsor may set eligibility for MTM at 2 or more chronic diseases. The sponsor can be more inclusive (e.g., they can sponsor MTM for people with 1 chronic disease as the minimum or "floor.") Sponsors cannot require patients to have more than 3 chronic diseases in order to receive MTM benefits.
   
   The sponsor may elect to cover MTM for any set of chronic diseases, but they must include at least 5 of the 9 "core" chronic conditions listed below:
   
   CMS suggested "core" chronic conditions include:
   • Alzheimer's disease
   • Chronic heart failure
   • Diabetes
   • Dyslipidemia
   • End-stage renal disease
   • Hypertension
   • Respiratory disease (e.g., asthma, COPD, other chronic lung disorders)
   • Bone disease (e.g., osteoporosis, osteoarthritis, rheumatoid arthritis)
   • Mental illnesses (e.g., depression, schizophrenia, bipolar disorder, other chronic disabling disorders)
     
     
2. Patient is taking multiple drugs covered by Medicare Part D
   Each Medicare Part D sponsor determines the specific drugs covered under its formulary. The sponsor may set the minimum number of drugs required for MTM at any range between 2 and 8. That is, the sponsor may offer MTM for those taking just 1 covered drug, but they cannot require that patients be taking more than 8 drugs to receive MTM services.⁴
   
   
3. Patient is likely to incur high drug costs
   CMS increases this amount each year by a margin of 11.76%. For 2016 the amount under Medicare Part D is ≥ $3,507. The sponsors look at first-quarter drug spending to determine the likelihood of spending this amount.

Expanded criteria: Medicare Part D sponsors are encouraged by CMS to have additional expanded criteria in order to offer MTM to a wider patient base.  They cannot make the criteria narrower, but they can optimize their programs, "to offer MTM to beneficiaries who will benefit the most from these services."⁴

How are eligible Medicare Part D recipients contacted for MTM services?
While contacting Medicare Part D candidates for MTM is done by the sponsors, it's a good idea for pharmacists to understand how these patients are approached. Medicare requires that patients who meet sponsor/CMS requirements be "automatically enrolled" for MTM. This means that the patient is considered to be enrolled unless he or she specifically opts out, or declines enrollment. If a patient meets the sponsor's criteria, he or she is automatically enrolled and must be considered enrolled for that calendar year even if the person's health circumstances change.⁴

Sponsors are required to use more than one approach to reach eligible targeted beneficiaries for MTM, rather than using passive offers only (such as a mailed flyer). So if a letter is sent, sponsors are expected to follow up via phone if there is no response.⁴ Each sponsor is expected to review its patient data quarterly to target potential MTM recipients.

In addition, patients enrolled in Medicare Part D can proactively contact the sponsor's pharmacy benefit manager or the medical care provider (physician) to request Medicare Part D MTM services.

How can pharmacists who provide MTM receive referrals for Medicare patients?
One way to receive referrals to provide MTM for this set of patients is to contact local providers of Medicare prescription drug coverage, including:

• Prescription Drug Plan–Part D (PDPs)
• Medicare Advantage–Part C

A listing of these providers can be found on the CMS.gov website under:
http://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/PartDContacts.html

Novel methods of connecting Part D enrollees are evolving. In Missouri, pharmacists registered with MO HealthNet (Medicaid) can log into Direct Care Pro DCPro, a system where MTM providers can access a database of patients in their area who are eligible for MTM and other consultative therapies.

Enhanced MTM Model Program to Begin January 1, 2017 in Some Regions5 Starting in January 2017, an "enhanced" MTM program will roll out in certain regions as part of a test by CMS. The Part D regions affected are: Region 7          Virginia Region 11        Florida Region 21        Louisiana Region 25        Iowa, Minnesota, Montana, Nebraska, North Dakota, South Dakota, Wyoming Region 28        Arizona The goals of the enhanced MTM program will be to offer flexibility to encourage more individualized interventions, and to engage pharmacists more extensively in the MTM process. Pharmacists will be asked to identify at-risk patients, optimize medication use, mediate communication with prescribers, and share information prior to office visits, such as comprehensive medication review (CMR) reports. The enhanced program will also increase payments for more extensive MTM interventions. Premium payments will be provided for Part D sponsors that are able to demonstrate reductions in healthcare costs. These payments systems are under development, but CMS has stated that certain PQA (Pharmacy Quality Alliance) measures may be used, including: Percentage of high-risk patients discharged from the hospital who receive an MTM encounter with a pharmacist within 7 days of discharge; Percentage of these patients who are readmitted to the hospital within 30 days; Percentage of prescriptions for chronic medications that are not picked up by the patient within 30 days. Sponsors located in these test regions will be required to submit different types of paperwork under the Enhanced MTM program, rather than the standard MTM documents. CMS will develop new MTM-related data collection requirements, and will require Part D plans to meet in order to participate in the Enhanced MTM model. According to CMS, these include: Interventions: Medication reminder device set-up Medication equipment or device education Chronic disease education Change length of therapy Outcomes: Patient condition resolved Patient cured Patient condition improved Patient condition poor Center for Medicare & Medicaid Services. Announcement of Part D Enhanced Medication Therapy Management Model Test. Sept 28, 2015. Available at: https://innovation.cms.gov/Files/x/mtm-announcement.pdf.

Pharmacist MTM providers can also access eligible Medicare Part D enrollees who through MTM provider companies such as Mirixa®, Outcomes MTM®, or PharmMD®.  These companies are third-party intermediaries between the health plan or payer and the pharmacy. The company provides names of identified patients to the pharmacy and assists with documentation and billing by providing software and other services. More information about these third parties can be found at:

• http://www.outcomesmtm.com/
• http://www.mirixa.com/
• http://sinfoniarx.com

Targeting Patients for MTM: Beyond Medicare Part D

Clearly, there is a vast population of patients apart from those enrolled in Medicare who can benefit from MTM services, and for whom cost savings can be recognized. As shown in Table 1, this includes patients who are younger than age 65, who may have only one chronic health condition, and who be dealing with a common problem such as nonadherence.

If a pharmacy organization is designing an MTM program to serve an employer, community group, or individual pharmacy patrons, the group of MTM-eligible patients can start with the Medicare Part D criteria and expand from there. Some possible conditions and situations are outlined below:

• Patients who are nonadherent to medications or medical therapies
  According to the World Health Organization, approximately 50% of patients in developed countries who have chronic diseases are nonadherent to medical therapies.⁶ Nonadherence may be identified via pharmacy records (failure to fill initial or refill prescriptions); from physician input or referral, or from lab records such as thyroid hormone values or HbA1C. Specific suggestions for addressing adherence issues through MTM services are provided in Module 14.
  
  
• Recent care transition
  Approximately 60% of medication-related errors in patient records occur during care transitions.⁷ Recent hospital admissions and discharges, as well as changes in medical provider or care setting, are ideal opportunities for MTM. Accountable Care Organizations (ACOs) are an example of the type of group that can partner with pharmacists to offer MTM at the time of care transitions, to prevent rehospitalization and promote safe and effective medication use.⁸
  
  
• Change in health status
  There is a great need for improved patient education for individuals who have recently undergone a change in health status. This may include patients who have received a new diagnosis for a chronic condition (such as rheumatoid arthritis or diabetes). Other circumstances might include:
  • Adverse events stemming from medication use or medication error
  • Need for change in therapy, increased dosage of medication
  • Progression of disease
  • Laboratory values outside of normal range
    
    
• Patients using high-risk medications or complex medication regimens
  According to the Institute of Medicine, errors related to medication knowledge are often related to "gaps in timely access to drug information at the point of care, in understanding of the complexities of the use of specific drugs, and in access to comprehensive knowledge bases needed to build expertise in drug therapy."⁷
  
  Pharmacists providing MTM provide an important service in filling these patient education gaps. Patients using a device (such as an inhaler) may receive insufficient instructions in the physician's office, or may forget the instructions by the time the prescription is filled.⁷ Examples of situations that may be amenable to MTM include:
  • Use of drugs with a narrow therapeutic index (e.g., warfarin)
  • Drugs with a high risk of therapy-related complications (e.g., some monoclonal antibodies)
  • Highly complex therapeutic regimens, such as a combination of injected and oral agents or a large pill burden per day (polypharmacy)
  • Need for monitoring in conjunction with medication
  • Drugs with variable dosage, e.g., PRN pain medications
    
    
• Request originating from healthcare provider or payer
  Physicians and other healthcare providers frequently lack the time necessary to provide thorough patient education, medication reconciliation, and adherence-related follow-up. Under some circumstances, systems may be in place to designate these functions to a qualified pharmacist and provide reimbursement for these services. Some examples of such systems might include the Patient-Centered Medical Home (PCMH, defined in the sidebar) and Collaborative Practice Agreements (described in Module 5, Communication Essentials).
  
  Payers may review or "mine" patient utilization databases to identify those who are frequently hospitalized or seek emergency care may also target and identify patients who are candidates for MTM. This may not be solely Medicare-eligible patients, but others who are high utilizers of services.
  
  
• Patient self-referral for MTM services
  Many occasions for patient education in the pharmacy are initiated when the patient asks a question about his or her therapy. MTM takes these types of inquiries to a more comprehensive level. In some settings, pharmacists provide MTM services on a fee basis on an individual basis, and these patients often realize cost savings in other aspects of medical care.⁹ A small but growing trend is the pharmacy setting where the sole "product" is the health management knowledge that the pharmacist can impart to the patient in one-on-one counseling sessions. Some situations that might fit well with this concept include:
• Wellness initiatives from patient, e.g. smoking cessation
• Patients who want to reduce out-of-pocket medication or medical costs
• Patient identifies self as needing/benefiting from MTM services
• Patients whose quality indicators are not being met

MTM Services Involving Caregivers

There are many scenarios where MTM services should be delivered in the company of the patient as well as a close relative or caregiver.

In some cases in which the patient is cognitively impaired or severely mentally ill, MTM services may be provided directly to the caregiver/s (without the patient present). Often such decisions are made in conjunction with a healthcare provider such as the patient's primary care physician. If a pharmacist attempts an MTM service and believes that the patient is unable to understand or unlikely to follow the instructions, this information should be shared with the healthcare provider, as part of the documentation process. At that point, a healthcare proxy should be determined who can legally make decisions on the patient's behalf and receive education about his or her care.

In other cases the patient may elect to bring in a spouse, adult son or daughter, or other caregiver to participate in the MTM process. State laws vary as to how a third party may participate in medical decision-making; this information is usually available from the state's Department of Health. In the MTM environment, this may range from having the patient provide informal consent for a caregiver or relative to sit in, to a basic HIPAA form, to having paperwork prepared for a healthcare surrogate or power of attorney. Some of these situations might include:

• Elderly patients who want an adult son or daughter to participate in MTM
• A person with a condition that may involve caregiver help to medicate (e.g., multiple sclerosis in which the spouse may be assisting with injections)
• A condition in which patients may be unable to help themselves in certain circumstances (e.g., a person with epilepsy or severe asthma, or a health condition or drug treatment that may cause mental cloudiness)
• Cases in which the family member or friend is a health professional or has medical knowledge that may help guide the decision making
• Long-term care settings

Sources for Further Information, Module 2 Centers for Medicare & Medicaid Services (CMS). CY 2014 Medication Therapy Management Program Guidance and Submission Instructions. April 5, 2013. Available at: http://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/MTM.html Patient-Centered Primary Care Collaborative. The Patient-Centered Medical Home: Integrating Comprehensive Medication Management to Optimize Patient Outcomes. Resource Guide, 2nd ed. June 2012. Available at: http://www.pcpcc.org/sites/default/files/media/medmanagement.pdf Kohn LT, Corrigan JM, Donaldson MS, Ed. To Err Is Human: Building a Safer Health System. Institute of Medicine: Committee on Quality of Health Care in America. Washington, D.C.: National Academy of Sciences, 2014. Available at: http://www.nap.edu/openbook.php?record_id=9728 Definitions Used in Module 2 Medicare Part D Sponsor Private insurance companies or payers that contract with Medicare to provide drug benefits to Medicare Part D enrollees. Patient-Centered Medical Home (PCMH) A model or philosophy of primary care that is patient-centered, coordinated, team-based, accessible, and focused on quality and safety. A philosophy of healthcare delivery that encourages providers/care teams to meet patients where they are; treat patients with respect, dignity, and compassion; and enable trusting relationships with providers and staff. Collaborative Practice Agreement An agreement that defines a formal relationship between pharmacists and physicians or other providers to allow for expanded patient-care services from the pharmacist and document the collaboration and cooperation of the provider. Accountable Care Organization As defined by CMS, ACOs are "groups of doctors, hospitals, and other healthcare providers, who come together voluntarily to give coordinated high-quality care to their Medicare patients."

References

1. Patient-Centered Primary Care Collaborative. The Patient-Centered Medical Home: Integrating Comprehensive Medication Management to Optimize Patient Outcomes. Resource Guide, 2nd ed. June 2012. Available at: http://www.pcpcc.org/sites/default/files/media/medmanagement.pdf.
2. Isetts BJ, Schondelmeyer SW, Artz MB, et al. Clinical and economic outcomes of medication therapy management services: the Minnesota experience. J Am Pharm Assoc. 2008;48(2):203-213.
3. Office of the Inspector General, Department of Health and Human Services. Medicare Part D Sponsors. OEI-02-07-00460, Oct 2007.
4. Centers for Medicare & Medicaid Services (CMS). CY 2014 Medication Therapy Management Program Guidance and Submission Instructions. April 5, 2013.
5. Center for Medicare & Medicaid Services. Announcement of Part D Enhanced Medication Therapy Management Model Test. Sept 28, 2015. Available at: https://innovation.cms.gov/Files/x/mtm-announcement.pdf.
6. World Health Organization (WHO). Adherence to Long-term Therapies: Evidence for Action. Geneva, Switzerland: WHO, 2003.
7. Aspden P, Wolcott J, Bootman JL, et al (Eds). Preventing Medication Errors. Institute of Medicine, Committee on Identifying and Preventing Medication Errors. National Academies Press, 2007.
8. Smith M, Giuliano MR, Starkowski MP. In Connecticut: improving patient medication management in primary care. Health Aff (Millwood). 2011;30(4):646-654.
9. Wittayanukorn S, Westrick SC, Hansen RA, et al. Evaluation of medication therapy management services for patients with cardiovascular disease in a self-insured employer health plan. J Manag Care Pharm. 2013;19(5):385-395.

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