As of 2006, the United States Centers for Medicare & Medicaid Services (CMS) began offering a prescription drug benefit known as Part D to Medicare beneficiaries. In addition to managing the coverage of specified medications, participating sponsors in the Part D program must provide eligible Medicare beneficiaries with access to medication therapy management (MTM) services (CMS, 2018b). One of the MTM services is an annual comprehensive medication review (CMR), where a qualified provider reviews with the beneficiary all medications (i.e., prescription, over-the counter, herbals, and supplements) that are being taken and identifies and resolves any medication-related problems. The beneficiary receives a written summary after the review, which includes a cover letter, medication action plan (MAP), and personal medication list (PML). As of 2013, CMS requires that the written summary follow a specified configuration known as the Standardized Format (SF).
The SF should contribute to the intent of the MTM program, which is to enhance safe and effective medication use. Preliminary research on the SF provided the current authors with insight on beneficiary use and satisfaction. In 2015, a survey was administered to 30 Medicare beneficiaries who had received a CMR (Cooke, Kaiser, Natarajan, & Brandt, 2015). One third could not recall their SF, and 28% of those who remembered receiving a SF stated that they preferred a shorter PML when they are taking multiple medications. The utility of a long PML was examined in another survey of nine Medicare beneficiaries who had also received a CMR (Cooke et al., 2015). In the survey, 67% of beneficiaries noted that they created a separate, smaller handwritten list of medications for reference, presumably because the PML was not user-friendly. Other stakeholders have also continued to raise concerns. Sharing the perspective of those implementing the SF requirement, the Academy of Managed Care Pharmacy® (AMCP; 2016) noted that the average SF is “10+ pages and costs an average of $1.39 to mail to the beneficiary” (p. 3).
The SF is meant to be shared with the beneficiary's caregiver(s), care coordinators, and health care providers. Clinicians and others in the field are concerned with the static nature of the SF, and the lack of electronic integration into the beneficiary's health care information (CMS, 2013). Despite increased provider demand for electronic access to medication history (Gabriel et al., 2015) and the steady increase in electronic exchange of health information among providers (Swain, Charles, Patel, & Searcy, 2015), the SF remains separate from the electronic medical record. Because there is limited published evaluation of the SF, the objective of the current study is to describe beneficiary, caregiver, and care manager perceptions of the Medicare Part D MTM SF, including its components and delivery method, and to inform potential modifications for its optimal use.
Study Context and Design
To attain an in-depth understanding of Medicare beneficiaries' opinions and perceptions regarding the MTM SF, focus group interviews were conducted. During the process of qualitative research, the extensive prior knowledge of a researcher on the research topic may introduce biases into data collection and analyses; hence, bracketing can be a useful tool to control this bias (Tufford & Newman, 2010). A bracketing exercise was conducted with researchers prior to the interviews. Memo writing was selected as the means of bracketing wherein research team members were given time to examine and contemplate their individual opinions and perceptions on the research topic through open-ended questions. Memo writing was followed by a group discussion to acknowledge and deliberate over any preconceptions, thus ensuring a more robust and meaningful study.
Sample Selection and Recruitment
Members of the AMCP MTM Advisory Group were asked to assist with identifying potential beneficiary participants and sites for the focus group interviews. MTM Advisory Group members contacted beneficiaries directly by telephone using a script developed by the University of Maryland School of Pharmacy (UMSOP). If the beneficiary was interested in being contacted, his/her name was sent to the UMSOP via secure electronic transfer. The UMSOP then contacted potential participants to further elaborate on study goals and terms for participation. During the telephone call, verbal consents to participate and collect participant demographic data were requested. For those who consented to participate in a focus group interview, a confirmation letter with specific directions to the site was sent in advance of the meeting via the United States Postal Service or e-mail. Case managers were contacted by networking among UMSOP contacts and through outreach with professional organizations.
Focus group interviews were conducted with Medicare beneficiaries who had received a CMR in the past 1 year, their caregivers, and case managers. The University of Maryland Institutional Review Board approved the study.
A semi-structured facilitator's guide for the focus group interviews was designed with open-ended questions. The framework to build the facilitator's guide was adopted from previous work accomplished by partnering organizations (Cooke et al., 2015; Moon et al., 2016). Questions in the interview guide were developed within a five-category framework of (a) awareness of the SF, (b) overall value of the SF, (c) content/usability of the SF, (d) delivery method for the SF, and (e) portability of the SF.
A facilitator conducted the focus group interviews in English, which were audio recorded, transcribed, and proofread by two independent research team members. Each transcript was independently coded by two researchers using NVivo® version 12 qualitative coding software. The semi-structured interview guide was used to develop a coding scheme. For instance, a question on the utility of the PML was: “Which information was the most important to you on the medication list, and which was the least?” Two codes, PML info important and PML info not important, were later generated around this question. Once the coding scheme was determined, it was followed by a perusal of all transcripts, after which the coding scheme was further refined. Next, each coder applied these codes to the transcripts. Once independent coding was completed, the two coders compared and discussed their coding to reach agreement. When differences in the coding were unresolved, the other research team members, including the primary investigator, were consulted and a consensus was reached. The coded quotes were then used to identify pertinent themes.
The AMCP MTM Advisory Group members involved in recruitment referred 42 potential beneficiary participants to the UMSOP team. Two individuals provided information on their spouse/caregiver and these individuals were also included. In addition, eight case managers were recruited. A total of 28 individuals were consented telephonically, and 23 participated in one of the five focus group interviews conducted between February and April 2018, at locations in North Carolina, New York, Arizona, and Maryland.
Table 1 provides demographic information on those who consented to participate in the focus group interviews. Of note, the majority of participants were younger than 65 (54%), female (64%), and White (75%). Approximately all participants had at least a high school education.
Demographic Characteristics of Beneficiaries (N = 28)
Table 2 presents some of the key statements based on the five-category interview framework: (a) awareness of the SF, (b) overall value of the SF, (c) content/usability of the SF, (d) delivery method for the SF, and (e) portability of the SF to illustrate emerging themes. Below are additional results and recommendations from the focus group interviews.
Beneficiary, Caregiver, and Case Manager Perceptions of the Standardized Format (SF)
Awareness of the SF
The familiarity with the SF was variable across all beneficiaries and caregivers. Although some recognized the SF immediately, others were either unaware or could only recall it vaguely. Except for one case manager, none of the other case managers recognized the SF. One beneficiary reported: “The pharmacist…. She's the one I sit down with every 12 months, more or less, to review all this. She fills it all up and then she sends me the cover letter and the sheets.”
Perspectives on Overall Value of the SF
Beneficiaries believe the SF to be a useful tool to keep track of medications, make notes, and record instructions. However, some beneficiaries said they had no reason to carry the SF with them when visiting their health care team because none of their providers had ever mentioned or discussed the SF. In addition, they preferred memorizing their medications or looking up information on the dispensed medication bottle labels when needed. As one beneficiary commented, “…to me that's the easiest way [memorizing information] and everything's on the bottle anyway.”
Several beneficiaries found it difficult to manage medication documents because each one of their multiple health care providers had a separate medication list or document. Case managers also held a similar opinion and favored a consolidated common medication list that could be shared across all health care systems and providers. All case managers were unanimously in favor of the SF and recognized its value in health care for Medicare beneficiaries. One case manager commented:
…a lot of our clients will have like three or four or five or more physicians that they are working with and especially if they are in two to three different systems, there's very little communication so that's really helpful you know...if we had something that we could put everything from all of their physicians on one page for them to see…would help.
Perspectives on Content/Usability of SF
Personal Medication List. Sections on the PML for the ‘“medication name,” “how I use it,” “why I use it,” and “allergies and side effects” were considered highly important. Beneficiaries and caregivers found these sections important because they helped to understand how the medications function and keep track of their treatment at times when they were not able to remember. Medication names, specifically the generic names, were requested for correct identification and classification. They also mentioned that knowing generic names would help make sure they were not taking two drugs of the same kind by mistake. As one beneficiary explained, “When you find that suddenly it isn't whatever drug that you've been calling it, it's another name because it's a generic [name]… and then that changes to another generic [name]…you are really lost.”
Few participants found the sections on “when I started it” and “when I stopped it” of value. Although they could be of use, these sections were usually incorrectly filled out or difficult for beneficiaries to recall. One beneficiary remarked, “I don't remember when I started taking something 15 years ago…except the slight piece that I've been taking it a long time.” One case manager also stated:
I can tell you I have been doing this for over a decade and I don't think I've had one patient that could tell me exactly when they started using something or when they stopped. So, to me that's irrelevant…. Maybe it could be useful somewhere.
Many participants considered the details provided in the medication list to be valuable as they could be readily shared with their health care team. Some beneficiaries and case managers also put forward a request to add a section on cost. Suggestions included adding the actual medication cost or medication formulary tier within their insurance plan. This information was perceived to be crucial to help them make better decisions and discuss alternatives with their health care team.
When beneficiaries and caregivers were questioned on the length of the medication list, most conferred the difficulty in handling multiple pages. However, they also accepted the need for the pages because they were taking multiple medications. Some case managers preferred the use of a single page for the whole list as elucidated in the quote:
I would say that the more pages, the worse it is, and people are not going to sit down and fill it out…. I have seen a very good medication list where it's on the same page…. You know it gives a very nice snapshot versus this one where if you lose a page, it's over, and as a provider you have to flip through four to five pages of medications, [which is] not useful.
Medication Action Plan. In most cases, beneficiaries and caregivers believed the MAP sections on “what I need to do,” “when I did it,” and “what has to be done” provided pertinent information for daily use. This information was especially important for those who had difficulty in recalling the medication review discussion or instructions.
The MAP also appealed to case managers in many respects. They agreed that it could be a great means for patients to record their medication-related instructions as well as make note of any concerns to be discussed with their physician or provider at the next meeting. Regarding the length of the MAP, most beneficiaries and caregivers favored a shorter and more concise plan. Some case managers also suggested making the action plan into a checklist:
Maybe simplifying it where it says “what I need to do” should actually have check boxes, lab work with a date, ask more information with a date…. If we can itemize it for them with a date then we might not need “when I did it” and “how I did it” because…the date should be there and then the next box would be “was it completed yes or no.”
Opinions on Delivery Method, Portability, and Updates
Of beneficiaries who recalled receiving the SF, they said they got it in the mail and mostly approved of this method of delivery after their CMR. Although some beneficiaries were familiar with the internet and operating a computer, many others said they had difficulty getting access to a computer as well as operating it to check anything online. Case managers agreed that most of their patients would have difficulty accessing the internet and favored delivery by mail.
In general, beneficiaries believed the medication review must be performed at least every year and more frequently if possible. One case manager specified:
My thought is—with everybody now mandated to have electronic medical records—it should be that every time there is a medication change, it should trigger the new plan being filled out and…sent to the patient. I think with each medication change it should be done. Also, a yearly visit should be a minimum of when that needs to be updated.
Most case managers concurred, and some recommended creating an online chart or list that could be updated as soon as there is a change in any medication. They also believed that if caregivers and case managers had access to these documents, it would ensure better health outcomes.
General Suggestions for the SF
Participants made several suggestions for information they believed should be included in the SF. The information they sought included dosage and timing for medications, side effects, and drug interactions with other drugs already on the list.
A beneficiary remarked:
The interaction that and any other drug they put me on is important to know. Because I normally have to call a cardiologist to know is it safe to take this medicine with the one I'm taking or not safe with the eight drugs I'm taking.
Beneficiaries also requested information on the class of medication. They explained that the class helps understand the how and/or why the medication is used for their condition. This information also helped them pick less expensive alternatives from the same drug class. Many participants expressed the need to know which drugs are mandatory or priority drugs and which drugs were secondary in comparison for maintaining health (i.e., which ones pose a relatively lesser risk if accidentally omitted). As a case manager clarified, “…whether it's essential for them to take or not or just maybe something that's again secondary to maintaining their optimal health.”
Case managers put forward several more information requests in addition to those noted above, including whether patients can afford their co-pay and where they fill their prescription(s). They also requested information on dose and schedule alternatives for their patients to improve medication adherence.
Medication-related harm is described in terms of adverse drug reactions or adverse drug events, which occur more frequently in older adults due to polypharmacy as well as age-related pharmacokinetic and pharmacodynamic changes (Parekh, Ali, Page, Roper, & Rajkumar, 2018). This is noteworthy because the rate of medication-related harm, noted by U.S. emergency department visits, has doubled (Shehab et al., 2016). To reduce medication-related harm, access to an accurate and up-to-date medication list is vital (American Geriatrics Society Beers Criteria® Update Expert Panel, 2019). Provision of this resource is the responsibility of the health care system to sustain meaningful workflow changes that impact the delivery of person-centered care. For instance, in 2011, CMS established the Medicare and Medicaid Electronic Health Record Incentive Program to encourage eligible professionals, eligible hospitals, and critical access hospitals to adopt, implement, upgrade, and demonstrate meaningful use of certified electronic health record technology. The Meaningful Use Program “Promoting Interoperability” will focus on interoperability, improve flexibility, relieve burden, and place emphasis on measures that require the electronic exchange of health information between providers and patients (CMS, 2018a). This initiative needs to consider programs such as Medicare's Part D MTM Program, along with medication reconciliation initiatives, and patients' preferences to ensure integration and minimize the burden on Medicare beneficiaries and those who care for them.
Another example of opportunities to align initiatives with the results of the current study is the Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act; CMS, 2014). The IMPACT Act requires the submission of standardized data by long-term care hospitals, skilled nursing facilities, home health agencies, and inpatient rehabilitation facilities. The IMPACT Act also provides an opportunity to address all priorities within the CMS Quality Strategy, which is framed using the three broad aims of the National Quality Strategy (CMS, 2016):
- Better care: improve the overall quality of care by making health care more patient-centered, reliable, accessible, and safe.
- Healthy people, healthy communities: improve the health of the U.S. population by supporting proven interventions to address behavioral, social, and environmental determinants of health in addition to delivering higher-quality care.
- Affordable care: reduce the cost of quality health care for individuals, families, employers, and government.
These aims can be achieved in concert with patients' goals of care if there is effective information exchange across care settings. Ideally, the IMPACT Act will further the work of longitudinal care planning. Initiatives such as electronic care planning rely heavily on medication lists. Transforming the SF into interoperable elements meaningful to beneficiaries would help address integration and improve goal attainment of increased medication effectiveness and safety for Part D beneficiaries (Look & Stone, 2018; Ogle, Cooke, & Brandt, 2015).
Nurses across care settings are critical in coordinating care and communicating MAPs. This information provides guidance to the health care team that focuses on the medication-related needs of Medicare beneficiaries and care partners. These recommendations must be incorporated into future revisions of medication documents, such as the SF, as well as medication lists and care plans. The current study findings illustrate that the information available from the SF is helpful but often the “take-away” is forgotten or underutilized. This study also adds to the body of literature that beneficiary-focused information should be concise and integrated into the delivery of care and a patient-centered care plan. Additional work is needed to evaluate how the SF can be modified to improve usability as well as demonstrate impact on reducing medication-related harm in older adults.
- Academy of Managed Care Pharmacy®. (2016, December30). Re: CMS-10396 medication therapy management program improvements [Letter]. Retrieved from http://www.amcp.org/WorkArea/DownloadAsset.aspx?id=21758
- American Geriatrics Society Beers Criteria® Update Expert Panel. (2019). American Geriatrics Society 2019 updated AGS Beers Criteria® for potentially inappropriate medication use in older adults. Journal of the American Geriatrics Society. Advance online publication. doi:10.1111/jgs.15767 [CrossRef]
- Centers for Medicare & Medicaid Services. (2013). 2013 Medicare Part D medication therapy management (MTM) programs. Retrieved from https://www.cms.gov/medicare/prescription-drug-coverage/prescriptiondrugcovcontra/downloads/cy2013-mtm-fact-sheet.pdf
- Centers for Medicare & Medicaid Services. (2014). IMPACT Act of 2014 data standardization & cross setting measures. Retrieved from https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-of-2014-Data-Standardization-and-Cross-Setting-Measures.html
- Centers for Medicare & Medicaid Services. (2016). CMS quality strategy. Retrieved from https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/Legacy-Quality-Strategy.html
- Centers for Medicare & Medicaid Services. (2018a). Medicare and Medicaid promoting interoperability program basics. Retrieved from https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Basics.html
- Centers for Medicare & Medicaid Services. (2018b). Medication therapy management. Retrieved from https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/MTM.html
- Cooke, C.E., Kaiser, M.J., Natarajan, N. & Brandt, N.J. (2015). Medicare beneficiary satisfaction with comprehensive medication review and the standardized format [Abstract]. Journal of Managed Care and Specialty Pharmacy, 21, S79–S80. Retrieved from https://www.jmcp.org/doi/pdf/10.18553/jmcp.2015.21.10.S1
- Gabriel, M.H., Smith, J.Y., Sow, M., Charles, D., Joseph, S. & Wilkins, T.L. (2015). Dispatch from the non-HITECH-incented Health IT world: Electronic medication history adoption and utilization. Journal of the American Medical Informatics Association, 23, 562–569. doi:10.1093/jamia/ocv151 [CrossRef]
- Look, K.A. & Stone, J.A. (2018). Medication management activities performed by informal caregivers of older adults. Research in Social and Administrative Pharmacy, 14, 418–426. doi:10.1016/j.sapharm.2017.05.005 [CrossRef]
- Moon, J., Kolar, C., Brummel, A., Ekstrand, M., Holtan, H. & Rehrauer, D. (2016). Development and validation of a patient satisfaction survey for comprehensive medication management. Journal of Managed Care & Specialty Pharmacy, 22, 81–86. doi:10.18553/jmcp.2016.22.1.81 [CrossRef]
- Ogle, S.M., Cooke, C.E. & Brandt, N.J. (2015). Medication management and e-care planning: What are the opportunities for the future?Journal of Gerontological Nursing, 41(10), 13–17. doi:10.3928/00989134-20150915-02 [CrossRef]
- Parekh, N., Ali, K., Page, A., Roper, T. & Rajkumar, C. (2018). Incidence of medication-related harm in older adults after hospital discharge: A systematic review. Journal of the American Geriatrics Society, 66, 1812–1822. doi:10.1111/jgs.15419 [CrossRef]
- Shehab, N., Lovegrove, M.C., Geller, A.I., Rose, K.O., Weidle, N.J. & Budnitz, D.S. (2016). US emergency department visits for outpatient adverse drug events, 2013–2014. JAMA, 316, 2115–2125. doi:10.1001/jama.2016.16201 [CrossRef]
- Swain, M., Charles, D., Patel, V. & Searcy, T. (2015). Health information exchange among US non-federal acute care hospitals: 2008–2014. Retrieved from https://www.healthit.gov/sites/default/files/data-brief/ONC_DataBrief24_HIE_Final.pdf
- Tufford, L. & Newman, P. (2010). Bracketing in qualitative research. Qualitative Social Work, 11, 80–96. doi:10.1177/1473325010368316 [CrossRef]
Demographic Characteristics of Beneficiaries (N = 28)
| <65||15 (54)|
| 65 to 74||8 (29)|
| 75 to 84||4 (14)|
| ≥85||1 (4)|
| Female||18 (64)|
| Male||10 (36)|
| White||21 (75)|
| Hispanic/Latino||3 (11)|
| Black||2 (7)|
| American Indian||2 (7)|
| Less than high school/did not respond||1 (4)|
| High school or equivalent||6 (21)|
| College or higher||21 (75)|
Beneficiary, Caregiver, and Case Manager Perceptions of the Standardized Format (SF)
|Domains of the SF||Emergent Themes||Representative Quote|
|Content and utility of personal medication list||Sections on “medication name,” “how I use it,” “why I use it,” and “allergies and side effects” found relevant
Medication names, specifically the generic names, requested for correct identification
Sections on “when I started it” and “when I stopped it” given less value
Copay/cost/possible alternatives were requested||“…knowing what medication is and why I use it. It's new but it helps to have it written out.”
“Information most helpful to me—the names of them [drugs], the generic names, what are they for. And…how you take them and why you take them.”
“There's dates in here that are incorrect. And it doesn't really matter because I only know when I started was years ago.”
“[It would help] to highlight the copay feature even if its reduced, what the alternatives are or what it would take in order to maintain their [beneficiaries'] prescription regimen.”|
|Content and utility of medication action plan||Affirmed as an excellent tool for recording instructions by beneficiaries, caregivers, and case managers
Sections on “what I need to do,” “when I did it,” and “what has to be done” considered relevant
Suggestions for a shorter plan in a checklist format
An aid to note down any queries or concerns to be discussed with health care providers||“…having it in print, now I can look at it, whenever I need to know was it before I ate or was it after, [because] it's in writing. Well that was a good thing.”
“[The section on] What I need to do. Especially when you don't have a good memory so also when I did it are helpful.”
“I think it could be overwhelming to have multiple pages. I think like the fewer words, the fewer lines of text, anything to condense it would be better.”
“It seems like it would be a nice worksheet for patients in between doctors' visits, too. A way for them to remember what their concerns are, too, and things that they need to bring up to their doctor.”|
|Delivery method and updates||Preference for mail and paper format as opposed to e-mail or online systems
Suggestions for more frequent updates of the medication list review||“I'm just old school. I'd rather have it all on paper and read it. It is more helpful.”
“For most people its yearly…. Yeah. That probably should be sooner.”|