Medication Therapy Management Strategies for Geriatric Patient Interventions: Medicare Part D Implementation

Introduction

The 2006 introduction of Medicare Part D prescription drug coverage has produced numerous plans to ensure availability of appropriate medications to the older adult (www.MyMedicare.gov or 1-800-MEDICARE for patient help and plans available). The complexity of the various prescription drug plans (PDPs) has produced confusion and uncertainty in many patients, caregivers, and healthcare providers attempting to provide the most economical care to those who most need this coverage for their medications.

As of February 28, 2007, all PDPs should have supplied their first year of medication therapy management (MTM) intervention data to the Centers for Medicare & Medicaid Services (CMS). Hopefully, by this date, many eligible patients in both community and long-term care (LTC) settings are signed up for and are receiving drugs approved by the various plans. The 95% of those over age 65 years residing in the community, as well as their families and caregivers trying to care for them, hope to delay or prevent joining the remaining 5% in various LTC settings, from personal care to assisted living to nursing facilities. What roles do medications play in keeping those older adults in the community group or increasing the need for acute and chronic institutional care?

The final stage of the Part D plan is for MTM services to be supplied by all healthcare providers. MTM services should be available to all patients who may need them, not just Medicare residents. Additionally, while figures relating to average routine medications per patient or monthly drug cost expenditures/patient can help identify where MTM might be needed, the reality is that appropriate treatment of many chronic disease states quickly compiles a lengthy list of medications in many cases.

A recent editorial summarized the pre-implementation survey of LTC healthcare professionals regarding how Part D would affect drug therapy outcomes and medication-related problems in the LTC resident. The findings were that over half of those surveyed believed that Part D would worsen outcomes of drug therapy and increase medication-related problems.¹

As defined by regulation, MTM programs are expected to: (1) optimize therapeutic outcomes through improved medication use; (2) reduce the risk of adverse events, including adverse drug interactions; (3) be furnished by a pharmacist, advanced practice nurse, or other qualified provider; and (4) distinguish between services in ambulatory and institutional settings. In the LTC institutional setting, medication regimen review (MRR; formerly known as drug regimen review or DRR) is required on a monthly basis for each resident and must be conducted by a consultant pharmacist under the F 428 section of the State Operating Manual (SOM). Perhaps, it may be fortunate that those LTC residents who are covered under Medicare Part D may receive duplicative MTM services if their annual medication costs exceed $4000 per year. It may be advantageous for multiple reviews of the medication regimen and patient compliance to be available. The interesting scenario may arise when MRR or MTM recommendations conflict with, or simply add to, the findings of the other service. The extent to which MTM services in selective residents differ from MRR services required for all LTC residents remains to be determined. There has been an excellent differentiation of MRR from MTM services published as a consensus paper (see www.ascp.com).

The immediate questions that arise with MTM services include how to provide prospective and retrospective MTM services, and what learning resources and certifications may be needed to develop a strategy for offering this service for geriatric patients. The next question is how to determine priorities for assessing the patient’s total medication regimen and disease, as well as drug history and which eligible patients will benefit most from these MTM services. Each plan may have its own method of pursuing these questions, but perhaps a historical research perspective on medication-related problems in older adults would be of benefit in beginning to answer these questions.

Historical Perspective to Medication-Related Problems

Up to one-third of hospital and one-half of nursing home admissions of older adults have been associated with medication-related problems.^2,3 Nearly one-third of medications being taken on a regular basis are not reported by patients or their caregivers on their drug history. Pharmacist-nurse-physician cooperation between levels of care increases medication history knowledge and problem detection.^4,5 Up to one-half to two-thirds of medication problems may be due to drug misuse; the remaining one-third to one-half are due to adverse drug reactions or interactions.^2-4

Drug misuse, noncompliance, or nonadherence problems involve lack of patient understanding of their drugs (eg, name, how to take it and the purpose of each, as well as improper use due to pre-existing conditions, such as aspirin-like drugs with a history of stomach or intestinal irritation or ulcers). Drug misuse may also result from under- to over-availability of medications, with or without MRR or MTM services. Adverse drug reactions (ADRs) are associated with patients using inappropriate drugs, too many drugs, or polypharmacy, seeing multiple prescribers and pharmacists, and not taking personal responsibility for medication knowledge. ADRs are an unwanted or unintended effect of medications that include side or toxic effects, allergic reactions, and idiosyncratic or unexpected reactions. ADRs occur when two or more drugs add to or interfere with an intended therapeutic effect of each other.^2-5

Up to 70-80% of ADRs are preventable by attention to patient history, and cooperation between patients and their caregivers, prescribers, nurses, and pharmacists. Fewer than one-tenth of ADRs are ever reported, per FDA MedWatch estimate. Some studies indicate that prescribers recognize or attribute ADRs to medications they have prescribed less than one-fourth of the time when they occur in the patient.⁶ A thorough review of medication-related problems in the elderly has been published.⁷

The final questions concern how best to communicate and follow up on MTM recommendations and to document beneficial, as well as adverse, outcomes of the acceptance and rejection of these recommendations. In order to determine whether individual practices are ready for MTM services, the American Pharmacists Association has developed self-assessment tools (www.pharmacist.com/MTM; www.aphanet.org/medicare).

Retrospective vs Prospective MRR

Retrospective methods include MRR in skilled and intermediate care LTC facilities, which has been mandated since 1974 by federal regulation. MRR may be 30 or more days after drug orders/changes and subsequent physical/lab findings are noted and recommendations are made. Prospective MRR methods include “Point-of-filling the prescription,” where an assessment is made before any new medication is added to the patients drug regimen. The American Society of Consultant Pharmacists (ASCP) Fleetwood Project found that prospective DRR discovered more medication problems and solved them more expediently than retrospective DRR. ASCP has been the leading force in attempting to identify and solve the medication-related access and adverse outcomes with Medicare Part D implementation. Its website (www.ascp.com) has abundant resources regarding the problems and solutions to Part D implementation in the various LTC settings.

The Omnibus Budget Reconciliation Acts (OBRA) of 1987 and 1990 require patient information (PI)--mostly written leaflets that may be read and comprehended to a variable extent by patients and/or their caregivers. These PI publications generally should identify the use, intended and most common adverse effects of each medication, and significant drug interactions to avoid. OBRA also requires that pharmacists identify and communicate significant drug-related problems of misuse or ADR to the prescriber. The medication receipt sheet that should be signed on assuming responsibility for the prescription in the community setting is an acknowledgment that the PI and communications have taken place.

Medicare Part D MTM services must be a separate assessment process from the LTC facility-mandated MRR and OBRA services. MTM is based on time spent and number of patient problems as of January 2006. The following elements are required to verify the service and are dependent on the type and level of MTMs:

•A review of the pertinent patient medical history (Hx), medication profile (prescription, over-the-counter, and alternative drugs or supplements)
•Interventions made and recommendations offered to patients, their caregivers, and healthcare providers (HCPs) for optimizing medication therapy
•Referrals to other HCPs, treatment, compliance
•Communications with other HCPs
•Administrative functions (including patient, caregiver, and family communications) relative to the patient and/or follow-up care

Examples of MTM services may be disease-state management programs for specific diseases or drug classes (eg, diabetes mellitus, high blood pressure, hyperlipidemia, anticoagulants) or specific drug classes or conditions (eg, psychotropics, falls), “brown-bag” sessions to identify drug use patterns and medication-related problems, or simply the alerts that arise in many computer systems when a suspected adverse drug interaction or duplication is noted on filling of a prescription and the interventions necessary to resolve the alerts.

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Inappropriate Drugs Research and F Tags

A review of 11 studies found that up to 40% of nursing home and 21% of community-dwelling elderly were receiving inappropriate drugs--predominantly propoxyphene, amitriptyline, and benzodiazepines.⁸ The risk factors identified for inappropriate drugs were polypharmacy, poor health status, and female sex.

Inappropriate drugs (Beer’s Criteria) have been delineated in 1991, 1997, and 2003 consensus studies.^9-11 Inappropriate drugs were based on contraindications from patients’ diagnoses or simply very high ADR rates when much safer drugs are available (eg, acetaminophen vs propoxyphene). A follow-up study that looked at inappropriate drugs in Georgia Medicaid patients found that the most common inappropriate drug, propoxyphene, increases ADR events by an overall risk (OR) = 2.34, to include ER visits, hospitalization, and death.¹² Further research on potentially inappropriate prescription (PIRx) medications in elderly nursing facility residents using the 1997 Beer’s CRITERIA found that residents who received any PIRx had greater odds of being hospitalized (1.27) and death (1.28) in the following month than those receiving no PIRx.¹³ What is unclear at this point is whether or not the LTC F-tags applied in the LTC resident will also be adopted for evaluating the MTM services in all of the Medicare Part D-eligible persons. An additional question is: Will providers of MTM services for residents of LTC facilities be eligible for reimbursement for these services? Preliminary findings have shown that in some/many cases, third parties (ie, Part D plans and others) excluded providers of MTM to residents of LTC facilities from reimbursement for these services. The F 329 tag, or Unnecessary Medications tag applied to the LTC resident, defines a medication as unnecessary when used:

1. in excessive doses or with duplicative therapy; or
2. for excessive duration; or
3. without adequate physical, psychological or lab test monitoring; or
4. without adequate indications for its use; or
5. when adverse consequences are evident which indicate the dose should be reduced or the medication discontinued or changed to a different medication; or
6. without gradual dose reduction (especially the antipsychotics, sedative/hypnotics and benzodiazepines).

Adverse Drug Reactions and Drug Utilization Review in LTC Residents

A four-year study of probable ADRs in nursing facility residents found that two-thirds of residents had two ADRs over that period, and that one of seven of these ADRs resulted in hospitalization.^14,15 The key factors in the ADRs were polypharmacy and failure to recognize relative to absolute contraindications to drugs that were prescribed. A recent five-year study of drug utilization review (DUR) topics that were deemed by a multidisciplinary HCP panel of highest priority in a nursing home resident population were falls intervention, medications, and cognitive impairment, depression and dementia assessment and interventions, nonsteroidal anti-inflammatory drug gastropathy and nephropathy intervention, pain assessment and intervention, diabetes mellitus intervention, osteoporosis and fracture risk assessment and intervention, post-stroke, myocardial infarction, and acute congestive heart failure interventions.¹⁶ The applicability of these drug therapy research areas to minimizing ADRs and improving medication usage in the general elderly population should be of highest priority for MTM intervention if the prior concept of the magnitude of medication-related problems leading to hospital and nursing home admissions is appreciated by all HCPs and healthcare planners.^2-5

MTM Recommendations Outcomes

The final question that may help determine the need and reimbursement mechanisms for MTM services is whether there are pharmacoeconomic differences in healthcare outcomes when medication therapy change recommendations to the primary HCP in an LTC facility are evaluated in terms of acceptance versus rejection of those recommendations. A two-year study found that even with a 90% acceptance rate, the $1094 per patient saved was negated by the $1101 lost with a 9.3% rejection rate.¹⁷

The question may be raised as to whether or not the $1101 is truly a loss or just a gain that was not achieved when comparing actual savings to the potential savings from 100% recommendation acceptance. The point is that the loss appeared to equal the savings, and some cost savings to the healthcare system may not be realized when intervention recommendation rejection costs are not considered. This question is even more telling in view of a more recent further fourth year of study in the same population with an 85% rejection rate that found a 40:1 cost-benefit ratio was lost with rejection of medication therapy change recommendations.¹⁸ The differences between comprehensive MRR and MTM services may be minimal: the MRR service is mandated for nursing facility residents; the MTM service is still being defined and begs for data from the various PDPs to document similar cost-analysis and outcomes of MTM services. It bears reiteration that CMS has required all PDPs to submit first-year MTM intervention data by February 28, 2007.

A two-year study found that comprehensive DRR of LTC residents detects a significant medication related problem (ie, unwanted effect of drug therapy) every other month throughout their length of stay.¹⁹ The consultant pharmacist has been shown to decrease overall medication costs, adverse drug reactions and interactions, medication errors, hospitalization, and mortality rates of these residents.²⁰ When the consultant pharmacist's services are discontinued, overall drug costs and drug-related morbidity and mortality have been shown to markedly increase, then subsequently decrease when consultant services are re initiated.²¹ The reduction of drug related problems and medication associated costs in LTC residents is associated with increased pharmacist involvement in comprehensive pharmaceutical services to include MRR that may also be considered as the basis for MTM.^17-21

Summary

The need for comprehensive MTM services has been described in terms of the types of medication-related problems that need to be addressed, resources to aid in preparation for MTM and outcomes from successful MTM intervention based on existing literature from ADR, cost-analysis, and comprehensive DRR/MRR intervention studies. What remains to be seen is whether HCPs will “…shine or fail” with this opportunity.²² A recent Medicare Part D update emphasized the need for prescribed guidance in MTM for those involved in the MTM process.²³

Additional Resources
For additional information, a recent Pharmacist’s Letter/Prescriber’s Letter entitled, “Developing and Implementing Successful MTM Services,” is highly recommended. This article gives an excellent summary of not just steps to take to begin MTM services, but it also details some of the challenges we face related to MTM, potential for reimbursement for services, and further patient and HCP resources.²⁴

A recent book offers excellent advice for HCPs, consumers and their caregivers about Medicare Part D prescription plans. The 150-page paperback explains how to avoid scams; what to consider if you already have coverage under a veteran’s benefit or retiree plan; how to work with your physician and pharmacist to make sure you are not taking duplicative drugs or drugs that counteract each other; how people with limited incomes can apply for extra coverage; and what you can do if a drug you take is not covered under a plan’s formulary.²⁵

Learning Resources Learning resources, certification, and certificates that are available for the pharmacist and other HCPs include:

1. ASCP-www.ascp.com. three texts: a. Fundamentals of Consultant Pharmacy, b. The Consultant Pharmacist Handbook, and c. Developing a Senior Care Pharmacy Practice: Your guide and Tools for Success. To access ASCP’s policy statement “Medication Therapy Management Services in Long-Term Care,” visit https://www.ascp.com/resources/policy/policystatements.cfm.
2. A 40-hour geriatric pharmacy review course for the certified geriatric pharmacist (CGP) exam and re-certification as a CGP may be found at www.geriatricpharmacyreview.com. These are offered by ASCP and the Commission on Geriatric Pharmacy. The CGP certification should be regarded as evidence that the pharmacist has advanced training and competency to both detect and offer recommendations to solve medication-related problems.
3. Cooper JW. Consultant Pharmacy and Long-Term Care from Senior Health Consulting Alliance at www.shca-ga.org - a 20-hour CE and certificate course through the UGA College of Pharmacy post-graduate CE department at www.rxugace.com. This and the next course are meant to complement the ASCP resources in 1 and 2. The text includes drug distribution systems, medication errors, inappropriate drugs in the older adults, lab tests and safe medication use in the older adult, as well as how to set up a LTC clerkship.
4. Cooper JW, Burfield AH. Geriatric Medication Management-A Clinicians’ Guide-a 30-hour CE certificate course and practical guide to knowledge, assessment tools, and interventions for most common medication needs and problems that occur in older adults. Available at www.shca-ga.org. Free 164-slide sets on MTM services,50 slides on safe medication use in the elderly and 84 slides on inappropriate drugs in the elderly are also available at this website under “Coop’s Corner “ in the pharmacist area. CE credit is also available at www.rxugace.com.

Dr. Cooper is the author of several publications and courses referenced in this article. Ms. Burfield is coauthor of two of these publications and one course.