As the country's population ages, providing quality care and accessible specialty pharmacy services is of the utmost importance. Here's a review of the key trends and major challenges.
Specialty drug trend is not only increasing in the community setting, but also among those pharmacies that service patients (ie, residents) who live in senior care settings such as long-term care (LTC) facilities. The specialty drug trend is increasing among the senior care population, and important considerations such as regulatory and personnel factors need to be taken into account when dispensing specialty medications to patients residing in LTC facilities.
WHAT IS SENIOR CARE?
Senior care is a broad term used to define geriatric patients who reside in a variety of care settings such as adult day care, assisted living, continuum of care retirement communities, LTC facilities (ie, skilled nursing facilities, nursing facilities), rehabilitation centers, and at home. LTC pharmacies are dedicated to serving patients across this spectrum and they are sensitive to the patient needs and interdisciplinary team coordination involved with the care of patients in these settings.
WHAT IS LTC?
Long-term care lies within the senior care spectrum. By definition, LTC is a variety of services that includes medical and non-medical care for people who have a chronic illness or disability.1
Most long-term care consists of non-medical care such as assistance with activities of daily living like bathing, dressing, using the bathroom, transferring to and from a bed or chair, and eating. The number of seniors needing long-term care is projected to rise to 13.8 million by the year 2030; of those, it is estimated that 5.3 million will reside in nursing homes and other long-term care facilities.2
In 2008, 21 million people had a condition that caused them to need help with medical and non-medical needs and half of them were over the age of 65.3 Although people oftentimes think of skilled nursing facilities when they think of LTC, the reality is that LTC includes care settings beyond geriatric skilled nursing. Other resident populations within LTC include mental health, developmentally disabled, HIV, hospice, and corrections.
INCREASING SPECIALTY DRUG TREND IN SENIOR CARE
The annual 2011 Managed Health Care Associates (MHA) Independent Long Term Care Member Study, an analysis based on 893 closed door LTC pharmacies that encompassed 2.8 million individual patient profiles, was the first to look at specialty product utilization in LTC, and it revealed a double-digit growth of specialty pharmaceuticals from 2010 to 2011. In particular, the study showed a 17% growth in the use of specialty medications used to treat multiple sclerosis (MS) and a 27% increase in specialty medications used to treat inflammatory conditions including rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis, and psoriasis.4
In addition, a review of dispensing data from pharmacies that service nursing home facilities and assisted living facilities from the first half of 2010 to the first half of 2011 showed an increase in several key metrics when looking at prescription information regarding biologics for inflammatory conditions5
• An increase of 29% in the number of patients receiving biologics for inflammatory conditions
• An increase of 39% in the number of practitioners who prescribed biologics for inflammatory conditions
• An increase of 47% in the number of pharmacies that dispensed biologics for inflammatory conditions
• An increase of 36% in the number of assisted living and nursing home residents who received a biologic for inflammatory conditions
• An increase of 42% in the number of prescriptions filled for a biologic for inflammatory conditions
The second annual MHA Independent Long Term Care Member Study to include specialty was released in the first quarter of 2012. It showed a second consecutive year of growth in prescription count among specialty categories within LTC pharmacies, including a 7% growth in the specialty medications to treat MS, a 17% increase in biologics for inflammatory conditions, and a 7% growth in the utilization of oral oncology medications within LTC pharmacies (see Figure 1).6
In addition to looking at prescription growth trends, the 2012 MHA Independent Long Term Care Member Study also sought to take a closer look at which physician groups were prescribing specialty medications to LTC patients from 2010 to 2011. The most common type of prescriber for MS, biologics for inflammatory conditions, and oral oncology was physicians identified as practicing internal medicine, and the second most common type of prescriber for these therapies was family practice physicians.
The 2012 MHA Independent Long Term Care Member Study also included a survey component in which 217 independent LTC pharmacies responded to a variety of questions regarding their practice. Respondents reported that 54% of pharmacies had dispensed a biologic for inflammatory conditions to patients residing in assisted living facilities and 51% had dispensed a biologic for inflammatory conditions to patients in a skilled nursing facility. Thirty-two percent of the pharmacies had dispensed a medication used to treat MS to a patient residing in an assisted living facility and 48% of pharmacies had dispensed an MS drug to a skilled nursing facility. Twenty-seven percent of the respondents had dispensed an oral oncolytic drug to patients in an assisted living facility and 45% of the pharmacies had dispensed an oral drug to treat cancer to a patient in a skilled nursing facility (see Figure 2).
In addition, LTC pharmacies have made significant investments in providing specialty services. Thirty-six percent of the respondents have patient education services focused on specialty therapeutic classes, specialty disease states, drug administration, and specialty drug therapy. Twenty-five percent have invested in systems to capture non–claims level data for reporting purposes and 24% of LTC pharmacies who responded to the survey have therapeutic management protocols and programs in place for specialty therapeutic categories.6
Based on the data from this study from the past 2 years, we expect growth of specialty to continue at a steep pace based on the increasingly aging population demographics, high adherence to medication regimens in senior care settings, and new products emerging in therapeutic areas with a high prevalence in the senior care demographic, such as gout, lupus, and oncology.
REGULATORY AND PERSONNEL CONSIDERATIONS WITHIN SENIOR CARE 7,8
Due to the varied regulatory environment in senior care and the unique attributes of care provided by LTC and assisted living facilities, there are several considerations that need to be taken into account when dispensing specialty medications to patients who reside in a senior care setting.
REGULATORY ISSUES IN LONG-TERM CARE
One important difference between longterm care and assisted living facilities is that LTC facilities are federally regulated, whereas assisted living facilities are typically state regulated with the regulations varying greatly from state to state. Therefore, while a more standardized approach to dispensing specialty medications can be taken when a patient is a resident in an LTC facility, a more customized approach must be taken from state to state when servicing patients within an assisted living facility.
As it is estimated that Medicare or Medicaid pays for about 70% of the care in US nursing facilities, it is extremely important to understand both programs and their implications in depth. Medicare Part A covers inpatient care in hospitals, skilled nursing facilities (ie, LTC), hospice, and some home health care. A prospective payment system (PPS) is utilized for a skilled nursing home stay and is provided as a per diem to the facility based on Resource Utilization Groups (RUGs). For medications dispensed to the resident under Medicare Part A, LTC pharmacies bill skilled nursing facilities directly. Some LTC pharmacies will enter into a risk-sharing agreement with the skilled nursing facility whereby the LTC pharmacy will charge the skilled nursing facility a per diem rate for Medicare Part A residents based on average medication costs. Certain medications, and in particular high-cost medications, may be carved out of this type of agreement and the pharmacy would charge separately for them. This prospective payment system has put pressure on the skilled nursing facility, medical director, and LTC pharmacy provider to actively manage and reduce, when possible, the costs of medications during a Part A stay. As many specialty drugs are high cost, it is important to consider reimbursement implications of therapy during a Part A stay as well as implications of a patient potentially discontinuing therapy or experiencing a lapse in therapy during this time. Proficiency in dealing with coverage determinations between Medicare Part B and Part D and Medicaid are also important when a resident’s Part A benefits have been exhausted and the patient has now transitioned to other prescription coverage.
LTC facilities are among the most highly regulated industries in the United States, with the goal being to protect vulnerable populations such as elderly patients. These regulations are created and revised by CMS and are published as a document known as the State Operations Manual (SOM). The consultant pharmacist and LTC pharmacy related regulations play an important part in ensuring safe use of medications from the care planning stage to the administration and documentation of the use of medications and their efficacy. It is critical when dispensing a specialty medication to an LTC patient to understand the federal and state regulations that govern medication procurement for these patients.
LTC facilities and some assisted living facilities (dependent upon the state) must obtain both dispensing pharmacy and consulting pharmacy services to fulfill medication needs and regulatory requirements. As per the SOM for LTC facilities, a consultant pharmacist is required to perform a medication regimen review (MRR) for each resident at least once a month. This MRR is focused both on resident-centered activities such as conducting an extensive review of the patient’s medication regimen and their associated care plan, and on facility-centered activities such as implementing and monitoring policies and procedures for safe medication use in the facilities. MRR helps to ensure that the resident’s medications are the most appropriate and most effective, are used correctly, and are the safest possible. MRR also seeks to prevent, identify, resolve, and report medication-related problems that may interfere with achieving the goals of therapy.
Consultant pharmacists may also provide disease assessment and management, MTM services, facility formulary management, drug information, educational programs, medication cost analyses, pharmacokinetic dosing services, medication storage inspections, and other medicationrelated services essential to residents and the facilities. It is important to understand the role of the consultant pharmacist in the senior care setting and ensure that he or she is engaged in and educated about specialty therapies that may be encountered.
PERSONNEL IN LTC FACILITIES
It is also important to consider all of the health care personnel—interdisciplinary team—involved in drug therapy decisions, delivery of medications, and medication administration for patients in LTC facilities when providing specialty medications to patients. The overall approach to a patient’s care within a long-term care facility is centered on coordinated care by the interdisciplinary team. This team may include but is not limited to medical directors, attending physicians, consultant pharmacists, geriatric nurse practitioners,directors of nursing, and the administrator. A medical director provides the overall clinical leadership in the facility and may serve as the attending physician for several patients. The attending physician provides most of the medical care within the facility. Access and availability to consulting physicians, such as specialists, can be variable and often extremely limited. Geriatric nurse practitioners employed directly by the nursing home are increasingly becoming more common, assisting in the daily management of the patient in absence of the physician being on-site. The director of nursing supervises overall nursing services within the facility, whereas the administrator is in charge of the day-to-day operations and overall health and well-being of the patients who reside there.
DISPENSING SPECIALTY MEDICATIONS TO SENIOR CARE PATIENTS
Often when treating patients who reside in senior care settings, there are important clinical and ethical questions that are addressed for each individual patient. One critical question related to specialty medications is determining if the patient should be treated or should continue treatment with a specialty drug or not. The answer is determined by doing an individual assessment of the patient’s circumstances, taking into account overall quality of life, care plan goals, patient comorbidities, and overall life expectancy. Additionally, there is often a focus by the interdisciplinary team on only aggressively treating the major medical issues currently having the highest impact on the patient. Lastly, there are also facility factors such as staffing, medication administration limitations, payer considerations, and access to physician specialists.
All of these specific factors, in addition to federal and state regulations and considerations of medication needs for patients residing in senior care facilities, add up to a unique set of challenges for dispensing complex specialty medications. However, recognizing that specialty drugs and biologics may be the most appropriate clinical choice for a patient, these challenges can be overcome using a team approach. The LTC dispensing pharmacy, together with the consultant pharmacist, should evaluate whether or not the specialty drug is conducive to administration in the specific facility for that particular patient and evaluate the pros and cons of a specific therapy. Pharmacy staff needs to ensure that the nursing staff is familiar with how to properly store and administer the specialty drug, particularly if the product is infused. Pen devices, prefilled syringes, and vials for infusion represent an educational opportunity for the consultant pharmacists with the nursing staff.
Evaluation should also take place for gaps in care. Gaps in care can occur due to transitions of care such as from a patient’s home to the hospital to an LTC facility and can be especially problematic during a Part A stay. Gaps in care for specialty drugs can also occur due to prior authorization challenges and meeting step therapy requirements for payers.
Consultant pharmacists play a critical role in the medication management of senior care patients, and they should be mindful of observing specific monitoring parameters for specialty drugs during medication regimen review. When a resident is taking a specialty drug, it is important to consider signs or indications of infections and whether or not there are any specific immunization recommendations that must be accounted for with co-administration of a biologic product. The consultant pharmacist is also vital to ensuring that any recommended laboratory monitoring for a specialty product is performed and evaluated.
Ongoing assessment of risk versus benefit is also critically important when using specialty medications in the senior care population. Care should be taken to evaluate the impact of the therapy on a patient’s activities of daily living and quality of life. The patient’s clinical status should be continually monitored and assessed and the care team should be involved in discussions of discontinuation if the risk is determined to have outweighed the benefits of continuing therapy with the specialty drug.
One of the most significant challenges that the interdisciplinary team faces is a lack of published research for specialty drugs that focuses specifically on the LTC population and for those patients over 85 years of age. In addition, clear clinical guidance is lacking on evaluating appropriate length of therapy and parameters around discontinuation of therapy for specialty medications for the senior care population.
Another significant challenge that is faced in providing specialty drugs to residents of senior care facilities is limited distribution. It is common business practice in the LTC industry that one pharmacy services the entire LTC facility. LTC pharmacies have the expertise and understanding of the regulations and nuances that accompany servicing nursing home patients. If that LTC dispensing pharmacy is not given access to the specialty drug needed to fulfill an order, significant barriers are created to getting the facility resident the specialty medication in a timely manner and to meeting all the regulations that are set forth by the federal government. In addition, this creates fragmented care that is difficult to manage for the dispensing pharmacy, attending physician, consultant pharmacist, and nurses who are responsible for storage and administration of the medication.
Despite these challenges, specialty drug trend in the senior care population continues to increase. Providing quality, accessible specialty pharmacy services to facilities that care for these patients is of utmost importance as the population in the United States ages. SPT
*The above information is a selective summary of publicly available information and is accurate as of the date of writing. Please consult the sources for complete reference information. The views expressed in this article are those of the authors alone and not of Managed Health Care Associates, Inc.
Long term care. US Department of Health and Human Services website. www.medicare.gov/longtermcare/static/home.asp. Published March 25, 2009. Accessed February 2, 2012.
ASCP Fact Sheet. American Society of Consultant Pharmacists website. www.ascp.com/articles/about-ascp/ascp-fact-sheet. Accessed February 2, 2012.
National Clearinghouse for Long Term Care Information. US Department of Health and Human Services. www.longtermcare.gov/LTC/Main_Site/Understanding/Definition/Who.aspx. Accessed February 2, 2012.
MHA Independent Long Term Care Member Study, 2011. Managed Healthcare Associates, Inc; 2011. Available upon request at MHALongTermCare@mhainc.com.
MHA data on file. Presented during “Biologics for Inflammatory Conditions: A Clinical Primer for Senior Care Pharmacists” at ASCP meeting, November 2011.
MHA Independent Long Term Care Member Study, 2012. Managed Healthcare Associates, Inc; 2012. Available upon request at MHALongTermCare@mhainc.com.
Consultant Pharmacist Handbook: A Guide for Consulting to Nursing Facilities. 3rd ed. American Society of Consultant Pharmacists. Revised December 2010.
State Operations Manual, Appendix PP: Guidance to Surveyors for Long Term Care Facilities. US Department of Health and Human Services; January 7, 2011. www.cms.gov/manuals/Downloads/som107ap_pp_guidelines_ltcf.pdf. Accessed February 2, 2012.
About the Authors
Stacey Ness, PharmD, MSCS, has worked in both national specialty pharmacy and payer organizations and has experience in clinical management, adherence and persistency programs, as well as chronic disease cost optimization strategies. Dr. Ness is active in the Consortium of Multiple Sclerosis Centers, Academy of Managed Care Pharmacy, National Home Infusion Association, and Hematology and Oncology Pharmacy Association, and has served on the Minnesota Medicaid Drug Formulary Committee since 2008. She is a multiple sclerosis certified specialist and currently serves as the director of specialty clinical services at Managed Health Care Associates, Inc, a health care services organization based in Florham Park, NJ.
Kimberly Binaso, PharmD, RPh, CCP, FASCP, CGP, FASHP, is currently the executive director of clinical services for Managed Healthcare Associates. Dr. Binaso earned her bachelor of science degree from Rutgers University and her doctor of pharmacy degree from the University of Florida. Dr. Binaso is a certified consultant pharmacist in the state of New Jersey, fellow of both the American Society of Consultant Pharmacists and the American Society of Health Systems Pharmacists, and a board-certified geriatric pharmacist. She has held several clinical management positions, working extensively as both a consultant and clinical pharmacist in senior care. Dr. Binaso serves as a national visiting professor and senior care expert presenter contributing posters and articles on a variety of geriatric clinical issues.