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Abstract

Objective:The objective of this study was to evaluate the impact of pharmacist’s intervention on annual comprehensive medication review (Annual CMR) for Medicare Part D beneficiaries. Background: To develop a new approach to assess Medicare Part D Annual CMR using a technological tool. Methods: One hundred sixty-three (163) eligible Medicare Part D beneficiaries were enrolled. By using an Electronic Health Record (EHR) Program, the pharmacist was able to assess laboratory, pharmacy, diagnosis, and patient information. A post-medication review summary was provided to the medical providers and patients which included a medication action plan. At the end of 3 months, 6 months and 12 months after the medication review, data were collected, assessed and compared. Results: The study showed that pharmacist’s interventions were recommended to seventy-four (74) enrollees which comprised of 45% of the total enrollees. It showed that at 3-month, 6-month, and 12-month intervals after the medication review, the recommended interventions acknowledged and implemented by the medical providers were 20%, 51% and 64% respectively, which showed a significant difference over a 12-month period (P-value <.05). Different types of pharmacist’s interventions that were recommended may include to initiate, to adjust and to discontinue medication. The most common disease states that required interventions were psychiatric disorder, cardiovascular disease, pulmonary disease, gastrointestinal disease, diabetes, dyslipidemia and pain. Conclusion: The finding of this study revealed that such a web-based EHR system was a very meaningful and effective tool in assisting pharmacists to assess the proper and safe use of medication in elderly patients.

Keywords

web-based electronic health record medicare part D annual comprehensive medication review (annual CMR)pharmacist’s interventions medication therapy management medicare part D beneficiaries

Introduction

In the U.S., Medication Therapy Management (MTM) was first recognized as a service provided to selected Medicare beneficiaries which was based on the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA 2003). Medicare Part D Prescription Drug Benefit was first available to the Medicare beneficiaries starting on January 1, 2006. Benefit was provided to its beneficiaries either through a Medicare Advantage prescription drug plan or a stand-alone prescription drug plan. Besides providing prescription drug coverage, Medicare Part D sponsors were also required to offer a MTM service to eligible Medicare Part D beneficiaries. The goals of MTM were to provide education and counseling to improve Medicare beneficiaries’ understanding of their medications, to improve medication adherence, to decrease the risks of adverse drug events and to detect patterns of improper prescription medication use. These MTM services were developed in cooperation with licensed pharmacists and physicians; and there was no consensus on the recommended mode of delivery for MTM, such as by face-to-face, tele-health or by telephone.^1-3

In 2004, a joint initiative of American Pharmacists Association (APhA) and National Association of Chain Drug Stores (NACDS) developed a consensus definition of MTM for the community pharmacy setting. The consensus definition of MTM was “a distinct service or group of services that optimize therapeutic outcomes for individual patients that are independent of, but can occur in conjunction with, the provision of a drug product.” This definition emphasized an additional key feature of MTM, that is, by providing documentation of the progress and serving as a liaison to the patient’s other healthcare providers. The framework of the MTM included five features, which were medication therapy review, personal medication record, mediation action plan, intervention and/or referral, and documentation and follow-up. Some of the pharmacist-provided MTM services or programs available were Project Improve Persistence and Compliance with Therapy (IMPACT), the Asheville Project, and other employer- or commercially sponsored programs.^3-6 Similarly, other MTM administrative service companies such as Outcomes MTM and Mirixa were formed and able to build a comprehensive system to enable pharmacist-led MTM services.^1,7-10

The MTM services were provided through the community pharmacy setting with features that involved a comprehensive medication review and an action plan. The action plan has proven to be effective in managing and monitoring various chronic disease states such as diabetes mellitus, hypertension, and dyslipidemia among elderly patients. Studies also demonstrated that such comprehensive MTM services could improve clinical outcomes, improved patient adherence, reduced hospitalization, decreased emergency room visits, and reduced healthcare cost.^11-19

On April 10, 2012, U.S. Department of Health & Human Services Centers for Medicare & Medicaid Services (CMS) issued a memorandum with the guidance to Part D sponsors and organizations who were interested to offer a MTM program. A Part D sponsor or administrator was typically defined as a designated party or organization tasked with the responsibility of running a benefit plan. The memorandum suggested that a Part D sponsor must have established a MTM program based on the following criteria: 1. To ensure that covered Part D drugs were prescribed to targeted beneficiaries, 2. To reduce the risk of adverse events for targeted beneficiaries, 3. The program may be furnished by a pharmacist or other qualified provider, 4. The program may distinguish between services in ambulatory and institutional settings, and 5. The program must be developed in cooperation with licensed and practicing pharmacists and physicians.²⁰ In general, each developed program should include prescriber interventions to promote coordinated care, an interactive comprehensive medication review with beneficiaries to assess their medication therapies and creation of a medication action plan, and frequent monitoring and follow-up of the beneficiaries’ medication therapies. In this MTM approach, the eligible beneficiaries must have multiple chronic conditions with three chronic diseases being the maximum number, and who took multiple covered Part D drugs, with eight Part D drugs being the maximum number of drugs and who incurred annual costs for those drugs above a threshold set by the CMS. A pharmacist or other qualified provider would undertake the medication review directly with the Part D beneficiaries in an interactive person-to-person or conduct it by using telehealth technologies in a real-time basis. The Medicare Part D beneficiaries must receive a written or printed summary of the results of the review.²⁰ In the required MTM program, the Plan D sponsors must offer a minimum level of MTM services to each beneficiary enrolled in the program that included all of the following: 1. Interventions for both beneficiaries and prescribers, 2. An Annual CMR with written summaries in CMS’ standardized format, and 3.Quarterly targeted medication review (Quarterly TMR) with follow-up interventions when necessary. Thus, starting in 2013, the MTM program offered by sponsors of Part D Prescription Drug plans must include an Annual CMR and to accompany with follow-up interventions as needed.

As plan sponsors were required to establish Annual CMR, they were given the flexibility by CMS for designing programs that best suited their landscape. Various strategies for conducting Annual CMR had been implemented to include an outreach telephone call, face-to-face visitation, utilization of various quality of care indicators, and also various pharmacist-led MTM programs.

The goal of this study was to evaluate the impact of pharmacist’s interventions in Annual CMR for Medicare Part D beneficiaries by using a web-based technology that can incorporate all the necessary electronic records information of the patients for meaningful and effective medication review.

Methods

Brand New Day (BND), a Part D benefit sponsor, started with a unique goal of improving the quality of life for its members and physicians, and has been doing business for more than thirty-five years in Long Beach, California.²¹ The Brand New Day model of care was designed with a focus on its members, members’ families, caregivers, and physicians in supporting each member’s healthcare needs through its comprehensive benefit program. This personalized benefit program helped to keep its members healthy and had care plans for those who had ongoing medical conditions such as diabetes, cardiovascular disease, dementia, or mental illness. Available to residents in California, individuals with Medicare and Medi-Cal or those who lived in long-term care facilities were enrolled with the Brand New Day HMO plan.

In compliance with the CMS requirement of Annual CMR regarding the covered Medicare beneficiaries for contract year 2013, Brand New Day had implemented a new web-based process to actively collect the patient’s health and medication information, to perform a comprehensive review of the medication, and provide an action plan to beneficiaries and their physicians. This documented action plan was to ensure that appropriate actions were implemented to improve the proper use and effectiveness of the medication. Collaborating with American University of Health Sciences (AUHS) School of Pharmacy, Brand New Day was able to develop a process by conducting Annual CMR for its Medicare beneficiaries.

Patients who participated in contract year 2012-2013 with Brand New Day HMO plans had met the criteria for Annual CMR and were enrolled in this program. The initial Annual CMR was conducted in October 2013 by a pharmacist and follow-up measures were performed until 2015 for a period of fifteen months. Patients who were considered eligible to participate in this Annual CMR were Medicare Part D beneficiaries who met all the following criteria:²⁰ 1. Enrollees had multiple chronic diseases, with three chronic diseases being the maximum number required for targeted enrollment. If the enrollees did not have the minimum number of chronic diseases to be eligible for the MTM program, the minimum threshold for each beneficiary may set at two or three.²⁰ In addition, target enrollees or beneficiaries with any or specific chronic diseases may apply to this review program. However, those with specific chronic diseases must have at least five of the nine core chronic conditions, such as Alzheimer’s Disease, chronic heart failure (CHF), diabetes, dyslipidemia, end-stage renal disease (ESRD), hypertension, respiratory disease (such as asthma, chronic obstructive pulmonary disease, or chronic lung disorders), bone disease - arthritis (such as osteoporosis, osteoarthritis, or rheumatoid arthritis), or mental health (such as depression, schizophrenia, bipolar disorder, or chronic and disabling disorders).²⁰ 2. Enrollees were taking multiple Part D drugs, with eight Part D drugs being the maximum number of drugs that may be required for targeted enrollment. However, the minimum threshold may set at a number equal to or between two and eight. 3. Enrollees were likely to incur the following annual Part D drug cost: for contract year 2013, the cost for covered Part D drugs were greater than or equal to $3144.²⁰

A total of one hundred sixty-three (163) eligible Medicare Part D beneficiaries who met the criteria for Medicare Part D Annual CMR program were identified and enrolled. This study was approved by AUHS Review Board (IRB) committee. To perform the Annual CMR, a sophisticated electronic health record (EHR) program, Cerecons™, which had the capability to extract and integrate clinical and administrative data from a variety of disparate sources was used. Cerecons™ was a SaaS-based platform for care coordination and patient engagement that used community-based electronic health records to deliver clinical decision support at the point-of-care and also gave patients access to their healthcare information. This software system was able to provide direct information retrieval and submission from patient care providers over a secure web interface; platform reporting tools related to patient demographics, physician profiling, and other standards-based measurement tools using data from eligibility, referrals, claims, and capitation to deliver real-time information sharing and actionable items; and physician software for online, paperless eligibility retrieval, authorizations requests, and claims submission. The features of Cerecons™ were presented in Table 1. By using this web-based EHR system, the pharmacist was able to access the patient’s demographic information, eligibility details, laboratory results, health risk assessment data (such as emergency room visits or ambulance occurrence, breast cancer screening, colorectal screening, glaucoma screening and others), problem list by ICD (International Classification of Diseases) codes, claims history, referral data, case data and medication list. At any time, the pharmacist was able to contact the physicians for any questions related to medication or diagnosis. Being able to access all the health, social, medication and wellness information, the pharmacist was able to review the proper use and effectiveness of medication taken by the enrollees. During the Annual CMR, the interventions initiated by the pharmacist included to initiate a new medication, to change the medication, to discontinue the medication, to order a laboratory test or drug concentration level, and generic substitution per formulary. Then a medication review sheet (MRS) was prepared as a medication action plan where the pharmacist was able to provide recommendation(s) on the Annual CMR that was performed. The MRS was uploaded into the EHR system to serve as a post-medication review summary to the medical providers and to the enrollees.

Table 1.

The Web-based Electronic Health Record.

Special Features of Cerecons^a
Complete referral form with auto demographic entry
On-line status to check progress on all referrals
CPT and ICD9 lookup
On-line messaging for quicker response to questions
Eliminate faxes not received
Automatic Authorizations

^aCerecons is now part of Medecision.

Data were collected at the first day of their comprehensive medication review by the pharmacist as a baseline data followed by the end of 3-month, 6-month, and 12-month intervals after the Annual CMR. Based on the recommendations by the pharmacist, data on pharmacist’s interventions were collected, analyzed and compared. Nominal and continuous data were analyzed by using appropriate statistical tests. A P value ≤ .05 was considered to be statistically significant.

Results

One hundred sixty-three (163) Medicare Part D beneficiaries were enrolled in the CMS Annual CMR program with Brand New Day over a period of 12 months. Table 2 showed the enrollee’s demographic characteristics, medical conditions and multimorbidity data. Seventy-three percent (73%) of the enrollees were considered to have more than five multimorbidity conditions as per the CMS requirements for Annual CMR. It was obvious that all the enrollees had at least 2 and more chronic medical conditions. The majority of the enrollees were White (47.2%) followed by Hispanic (21.7%), Asian (17.1%) and Black or African American (12.8%). There were more male enrollees compared to female with a mean age at 70.8 years (SD ± 5.2). The mean body mass index (BMI) of the enrollees was 27.03 (SD ± 5.42) suggesting that most of the enrollees were not obese. For a total of one hundred sixty-three enrollees, all of them had mental health conditions, which could include depression, schizophrenia, bipolar disorder, or chronic and disabling disorders. The other major chronic medical conditions among the enrollees were hypertension (76.6%), respiratory disease (72.3%), chronic heart disease (65.6%), dyslipidemia (60.1%) and diabetes mellitus (50.3%).

Table 2.

Patient Demographic Data, Medical Conditions & Multimorbidity.

Variables	Number of Enrollees (N = 163)
Demographic Data
Age, mean [±SD]	70.8[5.2]
Gender
Male	90 (55%)
Female	73 (45%)
BMI [±SD]	27.03[5.42]
Race
White	77 (47.2%)
Black or African American	21 (12.8%)
Asian	28 (17.1%)
Hispanic	35 (21.7%)
Others	2 (1.2%)
Medical Conditions
Alzheimer’s disease	30 (18.4%)
Chronic heart disease	107 (65.6%)
Diabetes mellitus	82 (50.3%)
Dyslipidemia	98 (60.1%)
End-stage renal disease (ESRD)	63 (38.6%)
Hypertension	125 (76.6%)
Respiratory disease^a	118 (72.3%)
Bone disease^b	41 (25.1%)
Mental health^c	163 (100%)
Multimorbidity
2 multimorbidity	10 (6.1%)
3 multimorbidity	12 (7.4%)
4 multimorbidity	22 (13.5%)
≥5 multimorbidity	119 (73.0%)

^aRespiratory Disease includes: asthma, chronic obstructive pulmonary disease, or chronic lung disorders.

^bBone Disease includes: osteoporosis, osteoarthritis, or rheumatoid arthritis.

^cMental Health includes: depression, schizophrenia, bipolar disorder, or chronic and disabling disorders.

After the comprehensive medication review, interventions provided by the pharmacist were recommended to seventy-four enrollees (74) or forty-five percent (45%) of the total enrollees in the study as shown in Table 3. A total of ninety-six (96) interventions with either one intervention, two interventions, or three or more interventions were recommended by the pharmacist to the enrollees. When interventions were compared at 3-month, 6-month, and 12-month intervals, the recommended interventions acknowledged and implemented by the medical providers were 20%, 51% and 62% respectively with the latter being statistically significance (P-value <.05). However, when comparing the interventions recommended for the first 6-month period, there was no statistically significant difference.

Table 3.

Enrollees with Interventions being Implemented.

Number of enrollees With Interventions Implemented (n = 74)¹	3-Month After Review	6-Month After Review	12-Month After Review
1 intervention	0	5	11
2 interventions	7	18	20
3 or more interventions	8	15	15
Total number of enrollees with interventions implemented	15	38	46
% of enrollees with intervention implemented	20% (15/74)	51% (38/74)	62% (46/74)
P > .05		NS	Significant

¹Total of enrollees with intervention recommended by pharmacist in the study = 74 (n = 163).

Table 4. demonstrated the different types of pharmacists’ interventions that were recommended during the medication review process such as to initiate, to adjust, to order lab tests, and to discontinue medication due to therapeutic duplication and others. For a total of one hundred seventy interventions initiated by the pharmacist, there were twenty-four interventions on adjusting drug therapy, ninety-nine interventions to discontinue drug therapy, twenty-seven interventions to initiate drug therapy and twenty interventions to order lab tests or drug level tests. At the end of 12 months, a total of seventy-four interventions were implemented as shown in Table 4.

Table 4.

Number of Pharmacist Interventions Implemented Over the Various Time Points.

Types of Pharmacist Interventions (n = 170)⁴	3-Month After Review	6-Month After Review	12-Month After Review
Adjust drug therapy	5	10	12
Discontinue drug therapy¹	17	39	47
Initiate drug therapy	3	6	7
Order lab and/or drug tests²	3	7	8
Total number of interventions	28	62	74
Number of patients no longer in the program³	0	4	7

¹Due to therapeutic duplication, inappropriate dosage or based on Beer Criteria.

²To order laboratory tests or drug concentration levels.

³Beneficiaries that no longer enrolled in the BND program.

⁴Total number of pharmacist interventions.

The finding of the study revealed that the most common disease states and medical conditions that required interventions were psychiatric disorder and cardiovascular disease as shown in Table 5. Dyslipidemia, gastrointestinal disease, dyslipidemia, pain, and diabetes were the more prominently common disease states that were reviewed by the pharmacist during the 12-month period.

Table 5.

Number of Pharmacist Interventions Implemented on Drug Groups.

Interventions Based on Drug Groups	3-Month After Review	6-Month After Review	12-Month After Review
Psychiatric disorder¹	13	19	24
Neurologic disorders	1	2	3
Cardiovascular disease²	14	23	29
Pulmonary disease³	8	9	10
Dyslipidemia	9	12	15
Gastrointestinal disease	7	10	12
Pain	5	9	10
Diabetes	3	7	9
NSAID⁴	4	6	6
Thyroid disease	3	5	6
Bone disease⁵	3	3	3
Renal disease⁶	2	3	3

¹Psychiatic Disorder includes: Schizophrenia, anxiety, depression, bipolar, mania.

²Cardiovascular Disease includes: Congestive heart failure, hypertension, myocardial infarction, atrial fibrillation.

³Pulmonary Disease includes: Asthma, chronic obstructive pulmonary disease.

⁴NSAID = Non-Steroidal Anti-Inflammatory Drugs.

⁵Bone Disease includes: Osteoporosis, rheumatoid arthritis, osteoarthritis.

⁶Renal Disease includes: End-stage renal disease (ESRD).

Discussion

The objective of this study was to evaluate the impact of pharmacist’s interventions on Annual CMR for Medicare Part D beneficiaries by using a web-based technology that can include all the necessary electronic records information of the patients for meaningful and effective medication review. The purpose of this Annual CMR was for the pharmacist to assess, review and provide feedback on proper and safe use of medications to the enrollees and to the primary care providers. At the time when CMS rolled out this Annual CMR program in 2013, there were no specific instructions to the plan sponsors or administrators regarding what method or approach to provide Annual CMR to eligible Medicare Part D beneficiaries. This study demonstrated that the pharmacist was able to effectively use a web-based electronic health record to accomplish an Annual CMR in collaboration with the primary care provider. The finding of this study revealed that such a web-based EHR system was a very useful tool in assisting pharmacists to assess and review the appropriate use of medication in the elderly Medicare Part D beneficiaries.

From the study, it was apparent that this digital device was an important tool for the pharmacist to perform effective Annual CMR. Using this EHR, the pharmacist was able to retrieve information about the patients, medical conditions, preventive assessment data, medication information and laboratory results. At the same time, enrollees and primary care providers were also able to access to this digital portal at their convenience. Thus, this EHR helped to expand the role of pharmacist to perform and in obtaining both meaningful and quality interventions for the proper and safe use of medication among these enrollees. It was shown that the acceptance rate for implementation of the pharmacist’s interventions by the primary care provider was very encouraging.^22,23

An alarming finding from this study was that all eligible enrollees had at least 2 or more chronic diseases or medical conditions which were considered as multimorbidity. In fact, it showed that seventy-three percent (73%) of the enrollees had been diagnosed with five and more chronic diseases or multimorbidity. In the U.S., it was estimated that 3 in 4 adults over age 65 suffer from two or more chronic medical conditions such as diabetes mellitus, chronic kidney disease, hypertension, and chronic pain.²⁴ As patients developed these multiple chronic conditions or multimorbidity condition, they are likely to increase health resource utilization, requiring more complex physician’s visits and increased health expenditure. Having multiple chronic conditions, patients are vulnerable to medication nonadherence and eventually leading to unfavorable outcomes such as unnecessary emergency room (ER) visits, hospitalizations, adverse drug reactions, declining functional status, and mortality.^24-26 Consistent with the finding from our study, there should be more studies focusing on pharmacist’s direct patient care role in improving proper and safe use of medication in patients with the complexity of multiple chronic conditions especially the elderly adults.

In the ever-changing healthcare environment, the role of pharmacists has continued to evolve along with the healthcare needs of our population. Besides dispensing medications, today’s pharmacists are taking a different role in an integral part of the healthcare team as medication experts to provide direct patient care in various practice settings. In this study, the accessibility to the web-based EHR allowed pharmacists to perform more patient care activities such as medication management, preventive care screenings and direct interaction with patients to identify potential drug interactions or related issues on the proper use of medication. Such activities conducted by pharmacists had shown to improve medication adherence and clinical outcomes for patients with chronic conditions such as diabetes, hypertension and cardiovascular disease.^12-15 In the study, Table 3 and Table 4 showed the number of interventions recommended by the pharmacist and the different types of pharmacist’s interventions that were recommended during the Annual CMR process. A total of one hundred seventy interventions was initiated by the pharmacist which comprised of forty-five percent (45%) of the enrollees in the study. Interventions recommended by the pharmacist could be either one intervention, two interventions, or three or more interventions based on the amount of medication that the patient was taking for chronic medical conditions. It was interesting to notice that by using this web-based EHR, the pharmacist was able to initiate, to adjust, to order lab tests, and to discontinue medication to provide comprehensive medication management. Interventions included the switching to generic drugs, changing to more effective or less side effect drugs, initiate lipid-lowering agents, low-dose aspirin, angiotensin-converting inhibitors, angiotensin-converting blocker based on evidence-based standard of care, and discontinued medication based on Beer’s Criteria.^22,23 From the finding, a total of seventy-four interventions were recommended by the pharmacists; 20%, 51% and 62% of these interventions were acknowledged and implemented by the medical providers at 3-month, 6-month, and 12-month intervals after the medication review respectively over a 12-month period, which demonstrated with a significant difference (P-value <.05).

The study revealed that the most common disease groups which were considered as non-communicable diseases that required interventions were psychiatric disorder, cardiovascular disease, dyslipidemia, gastrointestinal disease, pain and diabetes as shown in Table 5. Findings from other studies showed that certain conditions had higher frequency in their occurrence or re-occurrence such as depression associated with Alzheimer’s disease, diabetes and dyslipidemia, diabetes with hypertension and others.²⁷ Additional research in understanding the framework of this clustering of chronic diseases may help to better enhance patient adherence, improving clinical outcomes, and advancing health and wellness through the proper and safe use of medication.

Several limitations of this study were identified. First, the sample size (n = 163) was relatively small. The demographic data could be more appropriately represented if the number of eligible enrollees were included from multiple plan sponsors. Second, a face-to-face or a collaborative ambulatory care setting will be more effective in a direct patient care approach. Third, outcomes would be different if interventions by pharmacists could be on a continuous or interval basis. Fourth, it would be more informative if cost saving and other intangible benefits could be estimated appropriately through this study. Keeping in mind with the limitations as mentioned, by using web-based tool, pharmacists were able to recommend meaningful interventions to improve optimal drug use to improve health outcomes.

Conclusion

The finding from this study revealed that the Web-based EHR approach can be used as a meaningful and effective tool in assisting pharmacists to assess the proper and safe use of medication among the Medicare Part D beneficiaries through the Annual CMR.

Footnotes

Author’s Note

A part of this work was presented at the following conferences: American Association of College of Pharmacy (AACP) Annual Meeting, Pharmacy Education at Anaheim, California, USA on July 23-27, 2016; American Association of College of Pharmacy (AACP) Annual Meeting, Pharmacy Education at Grapevine, Texas, USA on July 26-30, 2014; and American Pharmacists Association (APhA) Annual Meeting and Exposition at Los Angeles, California, USA on March 1-4, 2013.

Acknowledgments

The authors would like to thank Laura Davis-Loschiavo from Brand New Day (BND) program and Pastor Gregory Johnson, Co-Founder of American University of Health Sciences for his full support on this project. This study had been approved by American University of Health Sciences (AUHS) Institutional Review Board (IRB) committee.

Author Contributions

Dr. Mok Thoong Chong contributed to the design of the study, data collection and analysis, writing of the manuscript, and preparation of the final draft. Desiree S. Chong, Doctor of Pharmacy (Pharm.D) Candidate, (dchong688@student.roseman.edu) contributed to data analysis, and preparation of the final draft.

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iD

Mok Thoong Chong

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Web-Based Electronic Health Record Program: A Twelve-Month Evaluation on Pharmacist’s Intervention in Medicare Part D Annual Comprehensive Medication Review

Abstract

Keywords

Introduction

Methods

Results

Discussion

Conclusion

Footnotes

Author’s Note

Acknowledgments

Author Contributions

Declaration of Conflicting Interests

Funding

ORCID iD

References