Feature Article
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From the Geriatric Research, Education and Clinical Center, St. Louis VAMC, St. Louis, Missouri, and Division of Geriatric Medicine, St. Louis University Medical School, Address for correspondence: John Morley, MB, BCh, Dammert Professor of Gerontology, St. Louis University Health Sciences Center, 1402 S. Grand, Room M238, St. Louis, MO 63104.
For other nutrition-related material, please visit the Council for Nutritional Clinical Strategies in Long-Term Care’s website at www.LTCnutrition.org or call Programs in Medicine at 610-325-4580.
Part III – OBRA Regulations and Administrative and Legal Issues
By David R. Thomas, MD, Hosam K. Kamel, MD, and John E. Morley, MB, BCh
Abstract Among other rules, this article reviews federal regulations on dietary services, food preparation, therapeutic diets, and frequency of meals, as well as guidelines on tube feeding. The authors also discuss possible prosecution for false, fictitious, or fraudulent claims regarding nutritional services. Finally, the authors cover the evolving Prospective Payment System and consolidated billing in relation to these services. (Annals of Long-Term Care 1998;6[10]:325-332)
Introduction Two Congressional acts, the Omnibus Budget Reconciliation Act of 1987 (OBRA ’87) and the Balanced Budget Act of 1997 (BBA ’97), contained regulations governing practices in the nursing home. OBRA ’87 had a major impact on general nursing care, including the Minimum Data Set (MDS), requirements for a medical director, and reduction of physical and chemical restraints. Regulations based on BBA ’97 initiate the Prospective Payment System and consolidated billing. These federal regulations have impacted nutritional status and created the standard of care in nursing facilities. Most of the confusion among physicians concerning compliance with these regulations stems from unfamiliarity with the regulations themselves. The regulations resulting from OBRA ’87 are divided into two parts. First, the law is stated. These statements are labeled by "F-tags" and a number. An "F-tag" is jargon for the actual law published in the Federal Register. Second, an interpretive guideline follows the regulation. The guidelines comprise the instructions used by surveyors to determine compliance with the law.
The regulations themselves are very simple. The interpretive guidelines explain the details. For example, the first nutrition-related regulation states that residents in nursing homes should not lose weight. However, weight loss does occur in large numbers of residents.1 Thus, the regulation explains that the resident’s clinical condition may make weight loss unavoidable. Yet, which conditions make weight loss unavoidable? The interpretive guidelines tell the surveyors how to look for clinical conditions that might make weight loss unavoidable. The focus of this review is to examine the three nutrition-related categories in the OBRA regulations. Poor nutritional status, at least as defined by commonly used physiologic parameters, is consistently associated with risk of future complications. Severe protein-calorie malnutrition alters tissue regeneration, inflammatory reaction, and immune function.2 Patients with severe malnutrition are at a higher risk for death, sepsis, infections, and increased length of hospital stay.3 Malnourished patients are more likely to have postoperative complications than well-nourished patients.4 The identification of persons at risk for malnutrition in elderly populations implies that a correctable condition exists. The goal of nutritional assessment assumes that identification of depleted nutritional markers will lead to improvement of adverse outcomes. Table I provides a list of the nutritional issues identified by the MDS.
Logically, correction of undernutrition seems simple. Because the problem is assumed to be inadequate intake of protein and calories, replacement of adequate nutrients should reverse the process. Therefore, nutritional support should reduce complications. The proof of this reasoning remains elusive.5,6
Malnutrition F-tags 325-326 state that, based on a resident’s comprehensive assessment, the facility must ensure (1) that a resident maintains acceptable parameters of nutritional status, such as body weight and protein levels, unless the resident’s clinical condition demonstrates that this is not possible; and (2) that a resident receives a therapeutic diet when there is a nutritional problem. What Are Acceptable Parameters of Nutritional Status in Long-Term Care? There is no adequate gold standard for determining nutritional status. Several tools have been proposed, including the Nutritional Screening Initiative,7 the Mini-Nutritional Assessment (MNA),8 and the Subjective Global Assessment.9 Of these, only the MNA has been validated in long-term care (LTC) settings.
Problems With the Diagnosis of Malnutrition Two methods have been used for the diagnosis of malnutrition. The first, arguably the gold standard, uses in vivo neutron activation analysis and tritiated water dilution techniques to define body composition. These techniques are costly and not readily available in nursing homes. A second method uses physiologic parameters, such as protein synthesis, serum albumin level, lymphocyte count, body weight, wound healing, muscle strength, or respiratory function. These measures of physiologic function are attractive because they are readily available in clinical situations.
When physiologic functions, such as albumin level or body weight, are used to diagnose malnutrition, error may be introduced. Serum albumin acts as an acute phase reactant.10 Physiologic stress (such as from surgical operations), cortisol excess, and hypermetabolic states reduce serum albumin even in the presence of adequate protein intake. Large reductions in body weight may indicate cachexia associated with disease rather than impaired intake alone. Therefore, poor nutritional status defined by these variables may indicate poor health rather than poor nutrient intake. Weight loss and serum albumin level may be independent markers for poor outcome regardless of nutrient intake.
Some investigators have suggested that clinical judgment in assessing nutritional status may be as good as objective measurements,11 but other investigators conclude that malnourished individuals cannot be identified by clinical examination alone.12 Although clinical judgment works extremely well at identifying patients with clearly established malnutrition, it is less efficacious at identifying patients who have a lesser risk. Patients who have reversal of nutritional problems are easily identified. In addition, nevertheless, many physicians have had inadequate training in nutrition, and a number of studies have demonstrated that physicians fail to diagnose or treat patients with protein-energy malnutrition.
The OBRA guidelines offer two suggestions for monitoring nutritional status: body weight and serum albumin level. However, there are no ideal weight tables for institutionalized patients. An analysis of weight loss or gain should be examined in light of the individual’s former life style as well as the current diagnosis. Suggested parameters for evaluating the significance of unplanned and undesired weight loss are given in Table II. Surveyors are instructed to use the following formula to determine the percentage of loss:
Patients with acceptable reasons for weight loss include those on a calorie-restricted diet, obese patients now on a normal diet, edematous residents who experience diuresis with treatment, and residents who refuse food. The physician and the dietitian must document the reason for food refusal and exclude such causes as depression and anorexia nervosa.
Laboratory values are also suggested as a guide to detecting malnutrition. The suggested laboratory values are given in Table III. Surveyors are warned to check the laboratory “normal” range. Additional guidelines include warnings that some healthy elderly people will have abnormal laboratory values either because of a disease process or for an unexplained reason. There is no requirement that facilities order any of the suggested tests. Altered iron status in many nursing home residents makes the transferrin level a questionable measure of nutritional status in this setting.
When Is It Impossible to Maintain Weight and Protein? In some residents who have inadequate nutrition, the underlying cause is clearly unavoidable. In these residents, the facility is obligated to have identified the resident as at risk and to trigger appropriate Resident Assessment Protocols. For these patients, the provision of an adequate diet, nutritional supplements, monitoring of food eaten, and periodic changes of diet may be used to try to correct the problem. It is important that the strategies used to encourage the resident to eat are clearly documented in the chart.
What Risk Factors Contribute to Malnutrition? The causes of malnutrition are numerous. (These causes were discussed in detail in Part II of this series.) Table IV lists the causes commonly encountered in the nursing home. Depression is one of the most common reversible causes of weight loss in the nursing home. An analysis of 6832 Minimum Data Sets from 202 nursing homes in seven states showed that depression was associated with weight loss.13 Clinical conditions for malnutrition appear in Table V.
Dietary Services F-tags 360-366 deal with dietary services. The facility must provide each resident with a nourishing, palatable, well-balanced diet that meets the daily nutritional and special dietary needs of each resident. There must be a full- or part-time dietitian and sufficient staff to serve food. The menus must meet the Recommended Dietary Allowances of the National Academy of Sciences, be prepared in advance, and be followed.
Food preparation (F-tags 364-366) must conserve nutritive value, flavor, and appearance. Food must be palatable, attractive, and at the proper temperature and be prepared in a form designed to meet individual needs. Substitutes must be offered of similar nutritive value to residents who refuse food served.
All therapeutic diets must be prescribed by the attending physician (F-tag 367). "Therapeutic diet" means a diet ordered by a physician as part of treatment of a disease or clinical condition in order to eliminate or decrease certain substances in the diet (eg, sodium); to increase certain substances in the diet (eg, potassium); or to provide food that the resident is able to eat (eg, a mechanically altered diet).
Therapeutic diets—such as diabetic, low-salt, and low-cholesterol diets—are often unpalatable and have been shown to be associated with weight loss, low albumin levels, and orthostasis in nursing home settings.13,14 In the nursing home, special diets should, therefore, be avoided whenever possible.15
Tariq et al,16 in a prospective study involving 18 nursing home residents with non–insulin-dependent diabetes mellitus, reported that the short-term substitution of a regular diet for a diabetic diet resulted in increased caloric intake without causing significant deterioration in glycemic control. Nursing home residents with diabetes may be placed on a regular diet with no concentrated sweets. In the authors’ experience, prescribing a regular diet to hypertensive residents or those with stable congestive heart failure (CHF) did not result in a significant worsening in their condition. However, a small group of residents with such conditions as advanced CHF or chronic renal failure may need to be placed on special diets.
Diets with different consistency, such as puréed and mechanical soft diets, are sometimes prescribed to nursing home residents who have difficulty chewing. In general, changing diet consistency was not shown to have a significant effect on nutrient intake.17
The frequency of meals is regulated by F-tag 368. Each resident must receive at least three meals daily, at regular times comparable to normal mealtimes in the community. There must be no more than 14 hours between a substantial evening meal and breakfast the following day, except as provided below. The facility must offer snacks at bedtime daily. When a nourishing snack is provided at bedtime, up to 16 hours may elapse between a substantial evening meal and breakfast the following day, provided that a resident group agrees to this meal span and that a nourishing snack is served.
The regulations do not meet the normal eating patterns of many Americans, and more institutional flexibility in matching meal schedules to residents’ needs would seem appropriate. Although it is not legislation, the American Dietetic Association recently issued an important position statement that should be invaluable in discussions with nursing home surveyors: "The quality of life and nutritional status of older residents in long-term care facilities may be enhanced by a liberalized diet. The Association advocates the use of a qualified dietetics professional to assess, monitor, and evaluate the need for medical nutrition therapy according to each person’s needs and rights."
Tube Feeding F-tags 320-322 state that, based on the comprehensive assessment of a resident, the facility must ensure that (1) a resident who has been able to eat enough alone or with assistance is not fed by nasogastric tube unless the resident’s clinical condition demonstrated that use of a nasogastric tube was unavoidable; and (2) a resident who is fed by a nasogastric or gastrostomy tube receives the appropriate treatment and services to prevent aspiration pneumonia, diarrhea, vomiting, dehydration, metabolic abnormalities, and nasalpharyngeal ulcers, and to restore, if possible, normal eating skills.
What Is an Unavoidable Tube Feeding? The guidelines suggest that a nasogastric tube may be unavoidable in patients with certain conditions. These conditions include an inability to swallow without choking or aspiration (in cases of Parkinson’s disease, pseudobulbar palsy, or esophageal diverticulum, for example); lack of sufficient alertness for oral nutrition (the resident is comatose, for example); and malnutrition that is not attributable to a single cause or causes that can be isolated and reversed. The facility must document that it has not been able to maintain or improve the resident’s nutritional status through oral intake. It is equally important to document the discussions with the resident and the family that may have led to a decision not to accept tube feeding. This recognition of the patient’s autonomy to refuse tube feeding is quite acceptable and within the province of the tenets of the Patient Self-Determination Act. When conflict exists between the resident, his or her family members, and/or the staff, it is important to consider the involvement of the institution’s ethics committee.
Complications and Prevention of Tube Feeding The intent of F-tags 320-322 is that a nasogastric tube feeding is utilized only after adequate assessment and when the resident’s clinical condition makes this treatment necessary. This requirement is also intended to prevent the use of tube feeding when ordered over the objection of the resident. Any decisions about the appropriateness of tube feeding for a resident must be developed with the resident or his or her family, surrogate, or representative.
Complications of tube feeding are extremely common, with up to 40% of patients dying of complications within one year.18 In general, enteral feedings are associated with poor outcomes in long term care residents.19 The guidelines suggest that complications in tube feeding are not necessarily the result of improper care, but the facility is responsible for providing assessment aimed at preventing complications. Probes for tube feeding complications are shown in Tables VI and VII. Guidelines for preventing complications are given in Table VIII.
Outcomes From Nutritional Interventions It is difficult, if not impossible, to differentiate undernutrition from cachexia by clinical evaluation. Provision of a diet to suspected undernourished patients that is complete in nutrient requirements provides the optimum environment for recovery. When the patient fails to improve despite provision of adequate protein and calories, the underlying problem may be irreversible.2
Extensive data from the literature suggest that cachexia may not be reversible even though adequate nutritional support is given.21,22,23 This confounding factor may be the reason why so few outcomes studies of nutritional interventions have shown positive benefits.
In a long-term care geriatric hospital, 501 newly admitted malnourished patients were randomized to receive either a regular diet or a regular diet plus twice- daily nutritional supplementation.24 Both experimental and control groups showed a decrease in weight index, triceps skinfold thickness, and mid-arm circumference. There were no differences between groups in prealbumin, albumin, or alpha1- antitrypsin levels. Most (59%) of the patients receiving supplementation did not improve during follow-up. The failure rate may be higher because the patients who were offered supplementation but refused are not included.
Enteral tube feedings demonstrate few long-term benefits, except in the case of malnourished hospital patients following a hip fracture.25 Only 6% of tube-fed, institutionalized residents ever gained weight over 11 months of observation.18 In this study, wide fluctuations in serum albumin levels occurred, but serum albumin was not normalized. Mean hemoglobin concentration did not increase. Aspiration pneumonia probably contributed to death in 40% of patients.
In a study of total parenteral nutrition (TPN), the outcome in elderly patients was dismal. In the 179 patients over the age of 65 years, no statistically significant improvement in body weight, body fat, lean body mass, extracellular mass, or body cell mass occurred after feeding. In a subset of 33 severely malnourished patients, there was suggested benefit.6 TPN is associated with a high complication rate. Peripheral parenteral nutrition has a lower complication rate and may be particularly appropriate for use in long-term care.
Medicolegal Aspects of Nutrition Novel theories of prosecution have been developed to address nutritional status in long-term care settings. Although the survey process with fines and sanctions has been in place for some time, the new approaches stem from the False Claims Act. Specifically, the government alleges that false, fictitious, or fraudulent claims are submitted for nutritional services when these services are not rendered.26 The clinical basis for the false claim was that decline in weight and failure of albumin level to improve occurred despite provision of 1560 calories and 97 grams of protein daily by gastrostomy tube. In a second resident, enteral feedings of 1500 kcal and 63 grams of protein were judged to be inadequate, because the calculated value was 2060 kcal and 103 grams of protein. In both these cases, excellent documentation of intake was provided, but this documentation was judged to be fraudulent because the patient did not gain weight or show improved serum albumin level.
The major implication of this approach to prosecution is that the charges are felony violations, subject to prison terms and/or fines. The result is an escalation in the importance of nutrition in long-term care settings. Civil suits for pressure ulcers and falls are becoming more common, and nutrition is often implicated in both of these conditions. Malnourished persons are at risk for falls,27 and postprandial hypotension is not a rare cause of falls in nursing homes.28 There is a need for controlled studies to examine nutritional outcomes when causes of malnutrition are vigorously treated and to look for the utility of orexigenics.
The Prospective Payment System and Nutrition The Prospective Payment System (PPS) was created by the Balanced Budget Act of 1997 in response to the perception that the system was producing spiraling costs that were difficult to monitor and were associated with significant fraud and abuse. The main feature of PPS is that skilled nursing facilities will no longer be paid “in accordance with the present reasonable cost-based system but rather through per diem prospective case-mix adjusted payment rates applicable to all SNF [skilled nursing facility] services.”
Consolidated billing is a comprehensive billing requirement under which the SNF is responsible for billing Medicare for virtually all of the services that the residents receive. These services include emergency department and doctor’s office visits, as well as transport for visits for care identified as being in response to a preexisting care plan diagnosis.
The basic allocation of cost reimbursement is based on the Resource Utilization Groups (RUG-III) patient classification system. The grouping into which a specific resident fits will be determined by the Minimum Data Set instrument. RUG-III is driven by the need for help with basic activities of daily living (ADLs) for five of its seven major categories. It assesses performance on “late loss” ADLs, one of which is the ability to eat independently.
The Extensive Services Category is one of the two RUG-III categories that is not ADL-driven, provided that the ADL score is at least seven. One of the services included in this category is intravenous feeding.
The Special Care Category is divided into three groups dependent on the resident’s ADL score. A number of nutrition or nutrition-related conditions place a resident in the Special Care Category. These conditions include dehydration, tube feedings, weight loss, and two or more skin lesions. In the case of enteral feedings, the resident needs to receive at least 26% of the caloric requirements and 501 ml per day through the tube. The new system will only reimburse for dehydration treated by hypodermoclysis when intravenous fluid administration is required. This would appear to be an extremely shortsighted and onerous rule.
Consolidated billing requires that all services are included in a single bill from the SNF. All nutritional supplements, placement and maintenance of intravenous lines, and orexigenic drugs will be billed by the facility.
Whereas failure to provide appropriate care under PPS will be considered Medicare fraud, numerous potential problems exist both for obtaining appropriate reimbursement and for providing care. For nonfraudulent reimbursement to occur, all physicians’, nurses’, and dietitians’ notes to document the problem will be required, and this documentation must then be appropriately reflected in the MDS. A new MDS will need to be filled out for each change of status, and a physician’s note will need to justify this change.
Another example of a potential problem is when the care plan documents weight loss as a problem. A physician would decide to insert a gastrostomy tube as an outpatient procedure. Under the present regulations, it is likely that the entire cost would be assessed to the nursing facility. Such would not be the case if the resident had been admitted to the hospital for the procedure.
We are learning to live with PPS and consolidated billing. The major nutritional components of PPS are summarized in Table IX.
Conclusion Overall, the regulations address most of the concerns about nutritional support in the nursing home. The survey process is essentially document-driven rather than outcomes-driven. Physicians tend to be outcomes-driven. Thus, problems with surveyors occur when the record does not provide documentation of the process of care, even though there may have been adequate compliance with all the regulations. When the documents do not address these components, the process may be cited. The criminalization of nutritional support intensifies the need to examine and document fully. The impending PPS will focus on the need for awareness of the regulations. Awareness of the regulations and simple documentation should provide for better patient care and fewer compliance problems. Similarly, PPS places a premium on documentation to allow nursing homes to be appropriately reimbursed.
Finally, it should be recognized that the nutritional status in a facility can be compared to regional, state, and national performance levels, utilizing the On-line Survey of Certification And Reporting Systems (OSCAR) reports. The OSCARs are based on reporting to the state through the MDS forms. Thus, they are only as accurate as the MDS reporting. However, PPS reimbursement demands accurate reporting. Table X gives an example of nutritional data that can be abstracted from the OSCAR reports.
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