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The American Journal of Managed Care November 2008 - Special Issue
How Similar Are States' Medicaid Preferred Drug Lists?
Jonathan D. Ketcham, PhD; and Jeffrey K. Ngai, MBA, MHSM
Systematic Analysis of Outcomes Evaluations Applied to Drug Management Programs
Carrie McAdam-Marx, RPh, MS; David T. Schaaf, MD; Anke-Peggy Holtorf, PhD, MBA; Benjamin Eng, MD; and Gary M. Oderda, PharmD, MPH
Medicare Part D Formulary Coverage Since Program Inception: Are Beneficiaries Choosing Wisely?
E. Anne Jackson, BS; and Kirsten J. Axelsen, MS
Currently Reading
Impact of Therapeutic Switching in Long-Term Care
Bryan R. Cote, MA; and Elizabeth A. Petersen, MA
Kenneth E. Thorpe, PhD
Primary Care Physicians' Views of Medicare Part D
Andrew J. Epstein, PhD, MPP; Saif S. Rathore, MPH; G. Caleb Alexander, MD; and Jonathan D. Ketcham, PhD

Impact of Therapeutic Switching in Long-Term Care

Bryan R. Cote, MA; and Elizabeth A. Petersen, MA
Switching medications for nonmedical (formulary) reasons in long-term care settings may increase Medicare Part D resident adverse effects and raise facility downstream costs.

Objectives: To collect clinician perceptions on the impact of switching medications for nonmedical (ie, formulary) reasons in long-term care settings under Medicare Part D and to use the qualitative findings to support more robust research into the effects of Part D policies on nursing home patients and providers.

Methods: We collected individual clinician accounts of experiences with and perceptions about Part D plans when medications were switched for nonmedical reasons, including diseases that clinicians believed were most medically risky for switching with nursing home residents and the common health outcomes of switching. Publisher HCPro’s long-term care readership database was used to reach survey participants. Individuals were classified by clinician type and then
e-mailed an invitation to take these electronically disseminated surveys in September 2007.

Results: A total of 569 total case histories representing 555 nursing homes were collected. About three-quarters of the case histories collected showed decreased efficacy after a nonmedical switch for Part D beneficiaries. Switching for those with hypertension, heart disease, diabetes, HIV, and bipolar disorder, among other diseases, was considered most medically risky in this population.

Conclusion: Nurses, physicians, and pharmacists who shared their perceptions regarding the effect of nonmedical switching in long-term care settings reported situations in which switching increased administrative time, increased side effects, and appeared to have increased downstream costs to plans.

(Am J Manag Care. 2008;14(11 Spec No.):SP23-SP28)

Analysis of provider experiences with nonmedical switching policies in long-term care settings indicated that:

  • Residents experienced an increase in adverse effects with their new medications.
  • Certain diseases were more medically risky for switching in this population and may lead to downstream costs for plans.
  • Pharmacy treatment effectiveness was generally less after a nonmedical switch, putting nursing homes unintentionally at risk for failing to comply with a Medicare quality-of-care regulation.
As growth in the senior population booms toward 40.2 million by 2010, the long-term care (LTC) market is emerging as a more important business line for managed care. Pharmacy and medical spending in the LTC population represents one of the fastest growing categories for Medicare Part D prescription drug plans. For example, of the 150,000 Humana LTC Part D members, approximately 148,000 are enrolled in the company’s stand-alone drug plan (as of August 2007), and costs for this population are 2 to 3 times higher than they are in the retail setting—highest in skilled nursing facilities.1

Given the potential clinical and cost implications of designing and managing a benefit for the LTC population, HCPro, a publisher of regulatory resources for nursing homes, undertook research to understand provider perceptions of and experiences with Part D plan policies. (HCPro publications primarily reach directors of nursing, consultant pharmacists, medical directors, nurse practitioners, and administrators who use the publisher for its regulatory resources and Medicare training.) The goal of this research was threefold:

1. Identify major challenges and Part D policies, and their effects on providers and patients in skilled nursing facilities.
2. Collect individual facility accounts through a qualitative survey that could be used as an impetus for more robust research and policy discussions.
3. Aid Medicare Part D plans in understanding the potential implications of their policies for the LTC population.

Initial Questionnaire and Phone Interviews
Using its database demographic profiles for each subscriber, HCPro selected a sample of 1200 clinicians who work in nursing homes representing all 50 states. In April 2007, HCPro disseminated an e-mail questionnaire to these subscribers, who had clinical credentials in nursing (RN, Director of Nursing), pharmacy (RPh, Consultant Geriatric Pharmacist), and medicine (MD, DO). The survey asked the recipients an open-ended question: What are your top 3 challenges in dealing with the new Medicare Part D prescription drug benefit?

A total of 884 clinicians representing 804 unique facilities responded (628 nurses and directors of nursing, 136 medical directors, 120 pharmacists). It should be noted that these 804 facilities are only a small portion (~5%) of the 16,000 nursing homes in the United States.2

Unsure how each respondent defined “switching” and the patient health impact of switching, the researchers conducted phone interviews with 10 randomly selected respondents. These interviews, which took place on September 18, 20, and 21, 2007, were with the following individuals: Teresita Orlina, RN, Director of Nursing, Potomac Valley Nursing Center, Rockville, Maryland; Matthew Murawski, RPh, PhD, Associate Professor of Pharmacy, Purdue University, West Lafayette, Indiana; Wendy Jobe, RN, Staff Nurse, Springfield, Illinois; Lesha Yerka, RN, Director of Nursing, Eden Park Nursing Home, Brattleboro, Vermont; Jannette Buchanan, RN, Director of Nursing, Ocean View Convalescent Center, Long Beach, Washington; Bonnie Hageman, RN, Nurse Manager, Mercy Living Plus, Oelwein, Iowa; Ellen Kelly, RN, BC, Certified Director of Nursing Administration, Colonial Hills Nursing Center, Maryville, Tennessee; Leigh Davis, RN, Director of Nursing, Town & Country Health & Rehab, Minden, Louisiana; Cathy Leone, RN, staff nurse, Mt. Ascutney Health Center, Windsor, Vermont; Leah Westover, RN, Director of Nursing, Infinia of Show Low, Show Low, Arizona; Malcolm Fraser, MD, President, Bay Geriatrics, St. Petersburg, Florida.

Follow-up Survey
To uncover more case histories and facility accounts as to whether outcomes for nursing home patients and day-to-day quality of life could be adversely affected when a Part D plan switches medications for nonmedical reasons, we developed a follow-up electronic survey. Our hope was to gather individual facility profiles and then analyze them to see whether there were any noteworthy trends. At the time of the research in September 2007, little information existed to show whether switching for nonmedical reasons in the LTC population led to any negative outcomes (eg, an increase in hospitalizations).

Three online surveys—one each for nurses, physicians, and pharmacists—were created to identify the prevalence of nonmedical switching and to learn what each provider group’s experience has been. Surveys contained the same questions generally. (See the eAppendix Table at for a list of the questions disseminated to the participants.) In each survey, we defined switching as therapeutic substitution; we further alerted each clinician filling out the survey that switching did not refer to substituting generic versions of the same molecule.

The initial survey respondents (n = 884) were invited to take the follow-up survey during the week of September 5, 2007. To ensure that they were qualified professionals and had the relevant experience beyond the minimum 10 years in LTC, HCPro asked each to fill out a pre-survey screening checklist to help identify their background in LTC. The checklist included these items:

• Minimum of 10 years’ experience in LTC setting.
• Membership in the major LTC associations (American Medical Directors Association, Association Directors of Nursing Administration/Long Term Care, American Society of Consultant Pharmacists).
• Attendance at 5 or more association meetings in the last 5 years.
• High understanding of F-Tag guidelines for nursing homes (based on rating scale).
• Working in facility with 90 beds or more.
• Experience with 3 Part D plans.
• Having switched or observed someone switch a medication for a nonmedical reason (required).
• At least 2 years working at or consulting for current facility (required).

The researchers only reviewed responses from individuals meeting 6 of the 8 criteria. Other information also was collected prior to the qualitative questions (ie, respondent’s title, location of facility).

The HCPro researchers acknowledged several limitations in collecting perceptions and individual case histories. For example, it was difficult to ask clinicians to recall their experiences from 2005 (before the Part D drug benefit took effect). To address this recall limitation, the research questionnaires asked respondents to provide general insights on the prevalence and implications of switching in this population in 2007 compared with before implementation of Part D.

Approximately 75% (N = 804) of the initial survey respondents commented that they had been experiencing various problems with medication switching or therapeutic substitution. Based on the 10 telephone interviews and other internal discussions, we defined switching as the practice of dispensing a chemical entity (within the same therapeutic class) different from the drug a physician originally prescribes, one that may require physician consent. More than 150 respondents to the initial survey were experiencing a greater number of requests by Medicare Part D plans and pharmacy benefit managers to “please switch patients to the formulary medication,” but at times “without regard to how they worked” in the institutional elderly population, according to commenters.

The follow-up survey resulted in 768 anecdotal case accounts. (For demographic information on survey respondents, see Table 1.) In all, 569 responses were included in the research analysis, representing 555 skilled nursing facilities. A total of 199 responses were not included because the clinicians either (1) had not worked at their current facility consecutively since before the inception of Medicare Part D (42 respondents) or (2) did not meet the screening minimum (157 respondents).

Switching resident medications due to a nonmedical/Part D formulary requirement was very common at the time of the survey in September 2007, according to the 569 cases reviewed. It was the most common reason for switching in LTC (Figure 1). Among the clinicians who responded, 71% said Part D switches occurred typically at the initiation of therapy, whereas 29% wrote in a comments box that they recalled instances in which medication switches had occurred after prescriptions had been in place. At the time of the survey, lack of efficacy was the most common clinical reason that a resident in LTC was switched from one drug to another. As Figure 2 shows, switches for nonmedical reasons appeared to be most common for patients with hypertension (68%), high cholesterol (66%), gastrointestinal/stomach conditions (62%), diabetes (51%), and depression (44%)—the 5 diseases cited most among all respondents.

More than three-quarters of the respondents (76.6%) said it was common for a resident’s new drug to be less effective after a switch for formulary reasons. In a nursing home, this is relevant for Medicare compliance reasons. For example, a portion of the clinicians noted circumstances in which a Part D plan’s formulary preference (the therapeutic switched drug) was tried and proven ineffective. As a result, these facilities were forced to dispense a drug  ineffective for the patient, and by doing so risked a violation of Medicare’s F-Tag #329 unnecessary drug guidelines (see Discussion section).

Side Effects
Almost half of the respondents (45%) said side effects typically increased after a nonmedical switch in this population, and 37% said there were situations under Part D when patients needed a completely new medication to treat a side effect respondents believed was caused by the nonmedical switch. According to one nursing director, “What impacts the facility most with these switches is that we’re seeing more side effects and as a result we’ve noticed a spike in using certain pain medications and antinausea medications in some cases. It takes longer, more staff time and causes more pain for the residents with switching to another formulary” (Teresita Orlina, RN, Director of Nursing, Potomac Valley Nursing Center, phone interview on September 20, 2007).

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