Nursing facility residents are hurt every day by these unintended barriers when facility administrators withhold needed and appropriate medications due to financial concerns or because they do not want their facility identified as an outlier on a particular QI. The topic of overuse of medications received attention in 1998 when HCFA moved to develop new survey tools in response to federal reports calling for action to correct weaknesses and vulnerabilities in the oversight of nursing facility medication use. Geriatrics-specific drug therapy quality indicators were supposed to help establish minimum quality standards in facilities squeezed by PPS-induced cost-control pressures. Unlike PPS, which affects only the relatively small percentage of nursing facility residents whose care is reimbursed by Medicare, QIs affect everyone in the facility. The QI on the use of nine or more medications is most disturbing, because residents with just two or three chronic conditions could easily need nine or more medications for appropriate management of their conditions. QIs were originally intended to identify only potential quality problems in facilities. The architects of the QI system envisioned a scenario in which surveyors would examine outlier facilities—those in the upper 10th percentile of all facilities in the state—more closely during on-site surveys. Unfortunately, with the QI of nine or more medications, administrators, who fear being in the top 10% of facilities with regard to medication use, try to reduce the overall number of medications used by residents. When all administrators act the same way, the medication-use benchmark falls and facility administrators feel a continuous pressure to reduce the number of medications used in their facility. The focus of nursing facility administrators on reducing medication use to satisfy QIs takes resources and time away from treating their residents’ preventable conditions. Consultant pharmacists are in a perfect position to explain or justify a particular course of pharmacotherapy. For example, while doing chart reviews, consultant pharmacists may recommend pharmaceutical-based interventions that focus on keeping patients healthy and preventing further decline. Some consultant pharmacists have already implemented disease management programs to prove the cost benefits of disease prevention. Disease management works best when there is a buy-in from everyone in the facility. Because of disease management efforts, more nurses and physicians now look to consultant pharmacists for answers in the clinical decision-making process. They are seeking partners who are not influenced by state benchmarks that have little to do with individual patient care. In addition to added regulation, SNFs also are threatened increasingly by lawsuits due to allegations of negligence and maltreatment of the elderly. Consultant pharmacists can help change perceptions of elder care with their knowledge of what medications may be safely added to patients’ drug regimens to prevent disease and improve quality of life. By forming partnerships with SNFs, long-term care pharmacy service providers can help pull SNFs through a difficult public image crisis and also assist with the appropriate management of disease—even if it means adding drugs.
SNFs and Long-Term Care Pharmacy Service Providers: Building Partnerships for SuccessOn November 29, 1999, President Clinton signed into law legislation that restored $2.6 billion in Medicare funding to SNFs over the next five years. Unfortunately, the bill was passed only after SNFs were struggling under PPS’s reduced reimbursement for resident care. SNFs were not in the best financial shape to handle PPS in the first place, and the lowering of the average daily Medicare reimbursement rate to $293 in 1999, compared with $343 in 1998, did not help. (The estimated reduction in Medicare spending over five years due to SNF PPS was over $16 billion, says Jade Gong, of Health Strategy Associates, Arlington, Virginia.)During the last five years, SNFs have experienced a general rise in vacancy rates. This trend reflects increased competition from assisted living facilities (ALFs) and lower reimbursement by Medicare. Some of the large chains also became "over-leveraged" and had troubles paying their debts as a result of declining profits. At this writing, two large nursing facility chains have filed under Chapter 11 of the U.S. Bankruptcy Code for protection from their creditors. According to Andy Bressler, an analyst with Bank of America Corp., "Under PPS, people thought bigger was better." Large nursing home chains that borrowed a lot of money to acquire ancillary companies, particularly in such areas as rehabilitation and subacute care, have been most in the news for their financial problems. ALFs are now competing for private-pay residents, who were once the sole domain of nursing facilities. Ironically, after competing for these residents, assisted living providers are arguing against excessive regulation, asserting that no one will be better served by turning assisted living regulation into the complex maze of nursing home regulation. The effects of this competition for patients is evident in looking at the latest financial statements of a publicly traded corporation whose main business is SNFs (Beverly Enterprises, Inc., of Fort Smith, Arkansas) and a publicly traded corporation whose main business is ALFs (Sunrise Assisted Living, Inc., of Fairfax, Virginia). In its third-quarter 1999 report, Beverly cited a 63% drop in earnings; Sunrise, on the other hand, cited a revenue increase of 49% and substantial growth. Regardless of the impact of PPS and increased competition, nursing facilities continue to play an essential role in the nation’s health care system. If nursing facilities had not received relief from the Balanced Budget Act of 1997, hospitals would have shifted the costs of high-acuity, post-acute care to other payers, potentially damaging the rest of the health care system. According to the Office of the Inspector General of the Department of Health and Human Services (HHS), overall, 87% of SNF administrators support the concept of PPS, and SNFs do not wish to retreat from the post-acute care market. SNF operators (for better or for worse) are surviving under Medicare PPS by:
Obviously, when SNFs cut back on ancillary services and avoid high-acuity patients, long-term care pharmacy providers suffer. In response, long-term care pharmacy providers are helping SNFs predict treatment costs and tailoring formularies to improve resident outcomes while reducing costs. When PharMerica (a Tampa, Florida, subsidiary of Bergen Brunswig Corp.) looked for evidence of a silver lining in the PPS cloud, it came up with two things—predictable PPS income and better coordination of care—as the basis of its plan to help SNFs cope with PPS.6 PharMerica developed a custom PPS service that starts with a formulary to offer cost-effective solutions, then adds a software tool to help facilities predict and manage the costs of pharmaceutical care for Medicare Part A patients, and, finally, adds a wide array of services, including pharmacy management and rehabilitation services. PharMerica was prepared to help SNFs cope with PPS because its management had years of experience working with managed care organizations, which also focus on getting more bang for the pharmaceutical services buck. Even with its three-tiered approach to predicting PPS income and coordinating care, though, PharMerica’s parent company, Bergen, recently experienced profits falling short of estimates. Bergen partly blamed the stock’s poor performance on tighter Medicare reimbursements to PharMerica. In Bergen’s fourth-quarter 1999 fiscal year results, the company took a charge (reported an operating expense) related to accounts receivable at PharMerica, and Donald Roden left as president and chief executive officer (CEO). The new chairman, Robert Martini, says Bergen has implemented a profit improvement initiative at PharMerica and believes the long-term care industry is starting to show signs of stabilization.7 Covington, Kentucky-based Omnicare, Inc., created its own proprietary drug formulary to provide better drug therapy and lower drug costs to SNFs under PPS. In addition, Omnicare has been successful in renegotiating many PPS contracts to more acceptable levels of profitability. In President Joel Gemunder’s statement on Omnicare’s 1999 third-quarter results, he spoke of his company’s Contract Research Organization group, which provides geriatric outcomes studies for a number of pharmaceutical clients. By expanding into geriatric drug research, specializing in pharmacy services such as on-site dialysis, and implementing disease management, Gemunder sees his company helping to ensure positive health outcomes for the residents it serves.8 At NCS HealthCare, Inc., of Dublin, Ohio, Kevin B. Shaw, president and CEO, reported in the corporation’s fiscal year 2000 first-quarter financial results that a lower census at his customers’ facilities and lower acuity levels of patients in those facilities had a negative impact on NCS’s operating results. The number of beds served by NCS declined when it terminated several accounts, and the company is renegotiating unprofitable PPS contracts. Shaw said accounts receivable collection has been and continues to be a major challenge for NCS, given the weakened financial condition of many of its customers. On the bright side, Shaw said passage of BBA relief would likely induce NCS customers to be more willing to admit medically complex patients, such as patients needing I.V. therapy.9 Neil Medical Group of Kinston, North Carolina, a smaller-scale provider of long-term care pharmacy services, reports PPS experiences similar to those of the larger providers. Director of Clinical Services Todd King says that since PPS was implemented, his company has noted a decrease in the acuity of residents it serves, as well as a decrease in the number of I.V. drugs used. This is either an effect of PPS or a coincidence, he says. To assist its clients with budgeting under PPS, King says Neil Medical has a team of designated consultant pharmacists who do prospective drug reviews of patients upon admission. This special team first assesses the efficacy and safety of treatments, then recommends cost-effective treatments to physicians. In addition, Neil’s pharmacists in the field are trained to find low-cost solutions for certain disease categories, and they are able to report savings to the facilities they serve. Overall, King says, the PPS fixes look good from a pharmacy standpoint. He is, however, concerned about the future of nursing facilities, and understandably so. "If they go, we go," he says. The optimistic pictures painted by some representatives of long-term care pharmaceutical services providers belie the changing financial arrangements, which are sometimes not in their best interest. SNFs are demanding all-inclusive per diems in order to control pharmacy costs, and pharmacy services providers have limited data with which to develop appropriate pricing methodologies. In addition, SNFs are asking for more generics, assistance with case management, and assistance with educating physicians, among other things. Risk sharing, case management, and educational assistance sound like balanced solutions, except for the fact that facilities can choose whom they want to admit, while pharmacies have no control over the case mix or physician prescribing. If the relationship between the SNF and the long-term care pharmacy service is not well managed, there can be more risk for the pharmacy service than sharing, which is why long-term care pharmacy services providers seem to be doing a lot of contract renegotiation these days. The results of SNF PPS ultimately affect residents. For example, nursing facility residents are increasingly not able to receive I.V. therapy in their nursing facility because when facilities are at financial risk, services such as I.V. therapy are discontinued. Under PPS, nursing facilities are forced to "reverse cherry-pick" (screen out expensive, medically complex patients before they are admitted) or suffer the financial consequences.
On Top of PPS: Quality IndicatorsIt gets worse before it gets better. Early in 1999, the nursing facility industry was already feeling the effects of PPS, in addition to increased vacancy rates, over-leveraging due to ill-timed acquisitions, and increased competition from ALFs. Then, on July 1, 1999, HCFA implemented a number of changes to the nursing facility survey process and added 24 QIs to assist surveyors in identifying potential problems related to quality of care or quality of life of nursing facility residents. Five of the indicators are based on Section O of the Minimum Data Set (MDS) and designed to provide specific information about the use of medications in the facility. Four of the five indicators focus on identifying potential overuse of medications.One of the overuse-of-medications QIs, the use of nine or more medications, is an indicator that appears to have a rational basis in theory but, in practice, has a negative effect on the quality of care provided to nursing facility residents. The indicator was developed by the Center for Health Systems Research and Analysis (CHSRA) under a grant from HCFA. The CHSRA staff chose nine medications as the break point after receiving input from an expert clinical panel and guidance from a thorough literature review. Use of MDS-derived quality indicators to compare nursing facilities with each other and to track changes in quality over time may not lead to improved outcomes, however, because nursing facilities lack sufficient staff and other resources to influence these indicators.10 For example, according to a 1995 study in the Journal of the American Geriatrics Society, nurse aides spent an average of 11.1 minutes per resident providing mobility and incontinence management assistance under usual care conditions but needed 64 minutes per resident to produce better outcomes in those areas.11 If the care processes needed to produce improvements in even a small percentage of the quality indicators are as time intensive to implement as those for mobility and incontinence, then very serious cost questions must be addressed.10 Where does the QI of nine or more medications fit in? It can potentially create worse outcomes. For example, when using fixed-dose combination drugs (to count as only one drug), if the fixed dose provides too much medication, more staff time and money will be needed to address potential side effects and adverse outcomes. Residents are not only shortchanged by PPS and resultant discontinued therapies, but are also put at risk by quality indicators that actually reduce overall quality of care.
Adding Drugs for the Prevention of Pain and DiseaseSo far, it sounds as if increased regulation, inadequate reimbursement, a bad public image, changes to the survey and enforcement process, and poor financial planning should put SNFs out of business. Luckily for the residents who need skilled nursing care for a number of complex medical conditions, SNFs are seeking partnerships with their ancillary services providers to ensure resident therapy needs are accounted for up front, at admission.The correct number of medications for a given patient is still determined by the needs of the individual patient. With J. Lyle Bootman’s study published in the Archives of Internal Medicine in 1997 (in which consultant pharmacists were shown to save lives as well as billions of dollars per year),12 consultant pharmacists arose as the answer to PPS and QI challenges. As consultant pharmacists know, residents with just two or three chronic conditions could easily need nine or more medications for appropriate management of their conditions. Consultant pharmacists put aside the fear of inciting the nine-or-more-medications trigger and the fear of improving a resident’s health to the point at which the resident is placed into a category of expected improvement. These fears are perpetuated when administrators do not recognize that long-term care pharmacy services extend beyond drug regimen review. Adding—yes, adding—drugs when a resident’s condition calls for it is the role of the consultant pharmacist in helping to ensure superior resident care. This is not to say that drug regimen review is unimportant. Elderly persons who suffer harmful drug effects cost the U.S. economy $20 billion annually in hospitalizations.13 Undertreatment of pain, depression, osteoporosis, congestive heart failure, arrhythmias, and heart attacks, however, has been documented, and undertreatment can lead to greater overall treatment costs when conditions are not adequately treated. When consultant pharmacists confront and propose solutions to undertreatment of disease, they can effect a shift from their role of offering episodic interventions to a new role of adding drugs for the prevention of disease. Their paradigm shift is supported by the Pharmaceutical Research and Manufacturers of America (PhRMA). PhRMA recently put together a pamphlet entitled "The Graying of America," in which 10 diseases of the elderly and the associated costs to the U.S. economy are listed. The business purpose of the pamphlet is obviously to enhance private-sector pharmaceutical research, but the publication also does a great public service by highlighting some of the ways in which pharmaceutical research is making progress against 10 diseases.14 The 10 diseases and their costs to the U.S. economy are shown in the Table. The first disease on the list, congestive heart failure, is the leading cause of death in people age 65 and older. Five million people suffer from congestive heart failure; 45,000 people die annually from it; and the disease costs $21 billion to the U.S. economy each year.15
Heart FailureHeart failure has been shown to be undertreated in the elderly. Use of angiotensin-converting enzyme (ACE) inhibitors and beta blockers improves survival and slows heart deterioration, but because these drugs are relatively new on the scene, treatment varies, and their full potential has yet to be seen.14Surprisingly, an old medication, spironolactone, approved for a variety of conditions, was found to reduce deaths from congestive heart failure by 30% and cut hospitalizations by 35% in a two-year study of more than 1,600 patients with severe heart failure. Spironolactone added to standard ACE inhibitor treatment has been reported to improve the 15%–20% survival benefit reported in trials of ACE inhibitors alone. On the disease management front, Louisville, Kentucky’s Humana Hospitals studied 1,100 congestive heart failure patients for one year. During the disease management program, pharmacy costs increased by 60% while hospital costs declined by 78%. The net savings from the disease management program were $9.3 million; the patients’ ability to perform ADLs went up 15%; and the death rate dropped to 10% from 25%.14 Adding appropriate drugs for congestive heart failure patients makes good clinical and economic sense. Of the $21 billion total cost to the U.S. economy of congestive heart failure, $15 billion is in direct hospital and nursing home costs.15 Adding appropriate medications and disease management by providers and consultant pharmacists can diminish the human and economic toll of the disease.
OsteoporosisFor osteoporosis, it’s as simple as adding vitamin D and calcium, according to Daniel T. Baran, MD. Osteoporosis underlies 1.5 million bone fractures or breaks each year. One of every two women over age 50 will have an osteoporosis-related fracture in her lifetime. Today, 8 million women and 2 million men have osteoporosis, and 18 million are at risk of developing the disease. The cost to the U.S. economy is estimated at $13.8 billion each year (or $38 million each day).16 What if simply prescribing calcium and vitamin D could make a difference in quality of life for osteoporosis sufferers while shrinking the $38 million spent each day on treating the disease?Osteoporosis has been described as an adolescent disease with a geriatric onset. For example, in a 1993 study by Komar et al. in the Journal of the American Geriatrics Society, bone mineral measurements were higher in women with adequate vitamin D levels, as compared to women with deficient or borderline vitamin D levels.17 In 1997, Dawson-Hughes et al. found that patients who received a combination of calcium plus vitamin D had significant total-body (but not site-specific) bone mineral density (compared to patients who took a placebo).18 Four medications show tremendous results in decreasing osteoporosis-related fracture and reducing morbidity, mortality, and hospitalizations in the elderly. Estrogen and alendronate are approved for both the prevention and treatment of osteoporosis; calcitonin is approved for the treatment of osteoporosis; and raloxifene is approved for the prevention of osteoporosis. Some of these medications have added benefits. Estrogen appears to raise high-density lipoprotein (HDL), or "good," cholesterol and lower low-density lipoprotein (LDL), or "bad," cholesterol, and keeps total cholesterol under control. It also seems to lessen the risk of heart attack. Raloxifene has been shown to decrease breast cancer risk. Therefore, even if these medications are more expensive than calcium and vitamin D, their other health benefits could outweigh the costs for the approximately 85% of women admitted to nursing homes who have osteoporosis and are at risk of fracture.14,19 According to Baran, if a nursing facility resident is nonambulatory, a physician could be less aggressive in treatment, but nobody is too old for calcium or vitamin D. New drugs and old standbys such as calcium and vitamin D should be used to reduce the risk of new fractures. PPS is all about prevention and a prospective view. Providers have the power to prevent or reduce the risk of osteoporosis, not just the power to intervene after a bone is broken.
Pain ManagementResearchers at the Systematic Assessment of Geriatric Drug Use via Epidemiology (SAGE) Study Group say daily pain is prevalent among nursing home residents with cancer and is often untreated, particularly among older and minority patients.1 Despite efforts by the World Health Organization to promote its guidelines on use of pharmacological agents to treat cancer pain, pain management remains poor.Roberto Bernabei, MD, of the SAGE Study Group, reports that there is no physiologic basis for a decrease in pain with increasing age. The false belief remains, however, that pain is less prevalent among the aged. The SAGE Study Group says failure to prevent and/or treat pain effectively at virtually all times is no longer acceptable and should be considered a first-line indicator of poor quality of medical care.1 The authors of the SAGE study, published in the Journal of the American Medical Association, found that 25%– 40% of elderly patients with cancer experience daily pain. The most undertreated groups included patients older than 75 years of age and African Americans, who appeared to have a 63% increased probability of being untreated for their pain. The results of the study confirm that there are age and racial or ethnic differences in the management of patients with cancer.1 Improving pain management for all residents should be a priority in nursing facilities because maximizing function and quality of life are often higher priorities than life extension in this population. Consultant pharmacists are part of the multidisciplinary approach that is needed to educate both clinicians and patients about the use of analgesic agents. Facility administrators, too, must stock opiates and ensure they have adequate staff to provide and monitor frequent analgesia administration.1 By developing multidisciplinary teams whose focus is on the appropriate management of pain, nursing facility administrators may solve possible discrimination issues in their facilities while improving their residents’ quality of life. Meanwhile, by continuing to treat individual patient needs, consultant pharmacists can help change health care providers’ misperceptions that elderly people and minorities do not experience pain the way other people do.
How to Go About Business in a Hostile Economic EnvironmentConsultant pharmacists know better than anyone the harmful effects of inappropriate use of medications. With vigilant monitoring, medications may be safely added to patients’ drug regimens to prevent disease and improve quality of life.SNF PPS and new survey enforcement of quality indicators are hard to swallow, they are ill managed, and reimbursements have been hacked to unacceptable amounts. The focus on prospectively managing care, however, is not without merit. As the saying goes, the opposite of managed care is "unmanaged care," and no one wants that.
With hope, BBA fixes will allow nursing facilities to admit higher-acuity Medicare patients at the rate at which they used to be admitted. With hope, too, quality indicators that focus on overuse of medication will not continue to pressure nursing facility administrators to interfere with the good judgment of consultant pharmacists and physicians who know the dangers of overuse of medications—and the benefits of new and preventive treatments. Many health maintenance organizations received bad press when patients were denied access to the emergency room (ER). Much like the arguments about over- and underuse of medications, overuse of the ER is costly, and underuse can be deadly. Most health plans have eased up on patient access to the ER, with issuance of health plan statements such as "if a reasonable person would have thought the medical event an emergency." With hope, good judgment will remain the key to good medical decisions in nursing facilities, too. Today, PPS and QIs dramatically alter drug utilization and drug choice in nursing facilities. These policies are in direct contradiction to the philosophy of Jerry Avorn, MD, who said, "Medications are probably the single most important health care technology in preventing illness, disability, and death in the geriatric population."20 Consultant pharmacists are at the center of the debate in which newer pharmaceuticals with fewer side effects are appropriate for preventing a host of killer diseases, but cost containment strategies lead to denial of these medications. Research efforts, such as the ASCP Research and Education Foundation’s Fleetwood Project, will bolster the consultant pharmacist’s role in preventing disease in the elderly, but until the project is complete consultant pharmacists should continue to operate under the following rule: The correct number of medications for a given patient is still determined by the needs of the individual patient. This golden rule is the prescription for the side effects of PPS and QIs.
References:
Barbara Eilenfield is Senior Editor of the Consultant Pharmacist.
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