The Honorable Donna Shalala
Secretary
Department of Health and Human Services
309-G, Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, D.C. 20201

RE: File Code HCFA-3745-P

Dear Secretary Shalala:

I am submitting the comments of The American Dietetic Association on the Medicare and Medicaid Programs; Hospital Conditions of Participation; Provider Agreements and Supplier Approval: Proposed Rule. (Federal Register, Vol. 62, No. 244, pages 66726-66763.) While we appreciate the Health Care Financing Administration's (HCFA) goals in this proposal, we do have significant concerns about the impact the proposed changes will have on quality health care and patient outcomes.

The American Dietetic Association (ADA) represents nearly 70,000 food and nutrition professionals serving the public through the promotion of optimal nutritional health and well being. There are currently over 63,000 Registered Dietitians (RDs)--the medical professionals uniquely educated, trained, and qualified to provide nutrition services in the integrated health care setting. It is estimated that close to eight in ten RDs work in the health care setting, from hospitals, to home health care agencies, nursing facilities, ambulatory care, and community health clinics. These RDs are specialists in nutritional physiology and its relationship to health and disease. They receive nearly five years of education and training specifically devoted to nutrition, including a significant amount of their internship in direct patient care. Nearly forty percent of RDs hold master's or doctoral degrees. No other class of professionals can match this level of expertise in the area of dietetics and nutrition.

ADA commends HCFA for its work to revise the existing Conditions of Participation to recognize the importance of patient satisfaction and outcome measures. ADA appreciates HCFA's focus on the integrated care process and the importance of contributions of various skilled professionals. However, a large number of RDs who practice in various health care settings, including hospitals and clinics, have reviewed the proposed rule and identified serious deficiencies, especially with the Nutritional Services section, which undermine the very goal of improved patient outcomes and integrated care that HCFA seeks.

Of greatest concern is the elimination of the "qualified dietitian" requirement. As discussed in greater detail below, retaining this single requirement is the most effective way to ensure patient satisfaction and improved outcomes while obviating the need for rigid organizational structures and process standards.

These comments are ADA's first opportunity to bring nutrition expertise to the revision of these rules. Because ADA was not contacted or consulted prior to the issuing of this proposal, we strongly recommend that HCFA address ADA's concerns before proceeding with publication of the final rule. ADA's recommended changes or additions to the proposed rule are provided below, along with supporting discussion for each recommended change.

§482.40: Condition of participation: Nutritional services.

Recommendation: Add "medical nutrition therapy" and "qualified dietitian" to the nutritional services section.

We recommend changing the title of this section to §482.40: Condition of participation: Medical nutrition therapy and dietary services and modifying the introductory paragraph to read:

The hospital must provide adequate medical nutrition therapy and dietary services to meet the needs of the patient population. Dietary services must be provided by adequately trained personnel, and medical nutrition therapy must be performed directly by or under consultation of qualified staff, to include qualified dietitians.

ADA notes that the term "qualified dietitian" should be defined in the definition section of the final rule.

The term "qualified dietitian" should be defined as: an individual who is registered by the Commission on Dietetic Registration of The American Dietetic Association, or who has the documented equivalent in education, training, and experience, with evidence of relevant continuing education.

SUPPORTING DISCUSSION

Patients' Needs for Personnel with Experience and Training in the Field of Nutrition

ADA recognizes and supports HCFA's efforts to provide patient-centered, outcome-oriented standards and to only include process-oriented standards that are likely to promote optimal patient care and produce positive health outcome. The changing health care environment requires all health professionals, including registered dietitians, to revise the tools used to monitor patient care in order to focus more on Continuous Quality Improvement and patient outcomes, and less on process. ADA members utilize this approach and have been at the forefront of innovations in quality patient care. For example, ADA has developed 20 protocols for the ambulatory care, home care, and long term care setting that describe the details of the care provided by the RD, along with expected outcomes, when a defined, predictable level of care is provided (1,2). The focus on quality patient care and performance improvement based on outcomes--concepts that HCFA articulates well in the proposal--is found in both the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) documents and ADA's protocols. Appendix A includes a sample of the protocol ADA developed for pressure ulcers. The Association would like to work with HCFA to assess the use of these protocols in survey documents and instruments that the agency develops as a result of regulatory changes.

In health care organizations, medical nutrition therapy (MNT) and dietary services play an important role in achieving facility goals pertaining to customer satisfaction, quality outcomes, cost containment, and revenue generation.

MNT involves the assessment of the nutritional status of patients with a condition, illness, or injury that puts them at risk. This includes review and analysis of medical and diet history, laboratory values, and anthropometric measurements. Based on the assessment, nutrition modalities most appropriate to manage the condition or treat the illness or injury are chosen and include:

• diet modification and counseling leading to the development of a personal diet plan to achieve nutritional goals and desired health outcomes;

• specialized nutrition therapies including intravenous (parenteral) or enteral nutrition.

The field of nutrition, especially in the hospital environment, is an increasingly complex area that requires the experience and training that can only be provided by qualified health care professionals, such as RDs. RDs are the qualified professionals to provide appropriate MNT which may include the interpretation or translation of complex diet prescriptions, identification of and counseling for potential drug and nutrient interactions, assessment of supplemental and tube feeding regimens, and facilitation of transition from one mode of therapy, such as total parenteral nutrition, to another, such as oral supplementation.

The need for qualified nutrition professionals has never been more obvious. In just one example, a recently published study in the Journal of the American Medical Association indicates that correctly prescribed drugs in American hospitals account for 106,000 deaths and 2 million illnesses a year (3). These tragic figures demonstrate that, even under the best of circumstances, patients can have adverse reactions to medications prescribed by their doctors. Dietitians are experts in drug-nutrient interactions, and they help patients and medical staff avoid potentially dangerous combinations. Another recent study points to the benefit of nutritional interventions and the resulting reduction in the use of medications by patients (4). We fear that eliminating dietitians from hospital staffs will only result in greater morbidity and mortality, since other practitioners lack the level of expertise both in the areas of drug-nutrient interaction, and nutritional intervention.

Throughout the proposal, HCFA has clearly recognized the importance of proper nutrition and has included it as a component of §482.25: Condition of participation: Quality assessment and performance improvement. However, the language and standards under HCFA's proposed §482.40 Nutritional services section are far too general and do not provide adequate guidance to the facility. Without specifying the need to employ qualified dietitians to oversee the provision of MNT in the hospital, nutrition goals and optimal patient outcomes outlined throughout this proposal will be at risk. The language HCFA has proposed could lead to the provision of nutrition services by other health care workers without sufficient education, training and experience in nutrition to ensure quality patient care. Their experience may be limited to work in the food service industry such as in restaurants or kitchens. Individuals may not have appropriate certification, licensure or credentials in nutrition. In fact, in nutrition alone, nonaccredited correspondence schools and other organizations have issued thousands of "degrees" and certificates that suggest that the recipient is a qualified expert in nutrition (5). Individuals with such limited experience or education may not have the qualifications necessary to provide patients with appropriate medical nutrition therapy or to effectively participate as members of the interdisciplinary health care team. Appendix B highlights some of the inadequacies in nutrition education and experience of selected health care professionals, and provides an overview of the competency-based approach for dietitians.

Registered dietitians provide comprehensive nutrition services that have been proven to prevent or delay the development of certain disease states in a multidisciplinary setting or through individual counseling. Studies have also shown that dietary counseling decreases the patient's hospital length of stay and therefore reduces health care costs. Appendix C provides a sample of research that shows improved patient outcomes when an RD is included as a member of the health care team.

Joint Commission on the Accreditation of Healthcare Organizations Standards

HCFA states in the preamble of the proposed rule that changes proposed are consistent with the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO). While ADA does not disagree with the need to revise current standards to focus on patient outcomes, it should be noted that the most recent edition of JCAHO Manual for Hospitals makes reference to dietitians in each of the 16 chapters contained in the document (6) and requires the services of dietitians in a number of standards. In fact, in the JCAHO Manual for Hospitals, qualified individuals, defined as dietitians, perform comprehensive nutrition assessments using criteria including diet histories, anthropometric measurements and evaluations, interpretation of laboratory tests, physical examinations for manifestations of nutrient deficiency or excess, and interpretation of drug and nutrient interactions. Clearly, JCAHO recognizes the important role that dietitians play as members of the interdisciplinary health care team in providing necessary nutrition services.

Like JCAHO, HCFA should specifically require hospitals to include the services of qualified dietitians in the provision of nutritional care. HCFA standards should not be lower. Standard requirements are critical to assuring that the quality of care a patient receives is consistent, regardless of the hospital in which that patient is treated.

Improved Patient Outcomes and Cost Savings

Medical nutrition therapy is critical to producing positive health outcomes for many diseases and conditions, and RDs, as active participants of the health care team, are essential to achieving improved outcomes. Cardiovascular disease, diabetes mellitus, HIV/AIDS, pressure ulcers, hypertension, cancer, burns and trauma, gastrointestinal and hepatic disease, prenatal care, and renal disease are just some of the diseases and conditions for which MNT, as performed by qualified nutrition professionals such as RDs, is a critical component to improved health outcomes and patient satisfaction.

Many clinical advances in patient care in general, as well as nutrition support practices in burns and trauma are the direct result of outcome trials whereby dietitians have been principal or co-investigators (7-8). Recognizing the critical role that performance measurement plays in healthcare, three RDs recently published the only book in existence that focuses on outcome measurement and research for the clinician (9).

HCFA, in recent meetings with ADA staff and members, specifically requested information on improved patient outcomes and the role of the RD. Per this request, ADA has done an extensive review and analysis of the scientific evidence supporting the role of MNT and the RD in improving patient outcomes. Appendix D represents a compilation of some of the scientific research documenting the critical role that nutrition and RDs play in improving health outcomes. This extensive list clearly highlights the need to include MNT as a an integral component of hospital operations, and the role of the RD in participating as an active member of the health care team in providing MNT.

§482.40: Condition of participation: Nutritional services.

Recommendation: clarify the menus condition and re-order.

(b) Standard: Menus. The hospital must prepare menus prepared in advance and meet the nutritional needs of the patient in accordance with the recommended dietary allowances of the Food and Nutrition Board of the National Research Council, National Academy of Sciences.

ADA recommends re-ordering the proposed standards (a) and (b) and making the following changes to the Menus Standard (new (a)). The proposed standard (a), should read as follows:

(a) Standard: Menus and Nutritional Adequacy. The hospital must plan menus in advance and prepare meals in accordance with prescribed orders to meet the nutritional needs of the patient. Meals, to the extent medically possible, should reflect appropriate published guidelines and standards for nutritional care, such as those established by the Food and Nutrition Board of the National Research Council and the Dietary Guidelines for Americans.

Supporting Discussion

ADA supports the need for "regular" menus to be based on current nutritional standards but cautions against the use of such a standard to apply to all menus or diets in the hospital. Hospitals must provide different menus to meet the needs of a diverse patient population. For example, patients who have undergone extensive surgical procedures or tests may be prescribed a "clear liquid" or "low/minimal residue" diet for a short period of time until they can transition to a more nutritionally adequate diet or receive nutrition support or total enteral or parenteral nutrition. As the proposal is currently written, the clear liquid diet would need to meet current recognized standards for nutritional adequacy; to hold a hospital to such standards would be unreasonable. Furthermore, there are many situations in which a diet in compliance with the recommendations proposed by HCFA would be contraindicated, and could jeopardize patient care. Patients who have experienced major trauma, such as burn patients, often require a diet that exceeds standard nutrient recommendations, and a diet that just meets HCFA's proposed standards would actually compromise their condition. Patients undergoing dialysis often require modifications to protein and other nutrients; their condition would also be dangerously impacted by a diet that merely meets the standards outlined by HCFA.

Furthermore, the National Academy of Sciences, Food and Nutrition Board has established a new method for developing a comprehensive set of reference values for dietary nutrient intakes, including the establishment of a set of reference values (called Dietary Reference Intakes (DRIs)) (10,11). This new approach recognizes the important role of nutrients and food components in the prevention of disease and promotion of health--not just the prevention of deficiency on which current RDAs are based. The complexity of these changes, and the application of new standards in the hospital environment, require the services of qualified nutrition professionals to interpret the new guidelines and incorporate them, as appropriate, into the existing menu system. This points again to the need to employ RDs who are uniquely qualified to interpret and apply complicated issues and technical documents to the health care setting.

§482.40: Condition of participation: Nutritional services.

Recommendation: re-order this condition.

(a) Standard: Sanitary conditions. The hospital must provide food to the patient that is obtained, stored, prepared, distributed and served under sanitary conditions.

As stated above, we recommend that this standard be re-ordered to be Standard (b). We recommend no other change to this standard. ADA wants to commend HCFA for recognizing the importance of ensuring that food is prepared, served and stored under sanitary conditions. Just as the field of nutrition grows increasingly complex, so too have the areas of food safety and sanitation. This complexity--a direct result of the globalization of this nations' food supply--requires the expertise of professionals with specific training and experience in food service, sanitation, and food safety.

ADA does urge HCFA to issue guidance to hospitals that is in line with current food safety standards, such as those described in JCAHO documents, the Food and Drug Administration Food Code document, and other recognized sources of accurate information on safe food standards and handling.

§482.125: Condition of participation: Human resources.

Recommendation: provide more guidance.

(a) Standard: Credentials/qualifications. (1) The hospital ensures that individuals who supervise and/or furnish services to hospital patients, including services furnished under contracts or arrangements, are qualified to provide or supervise the services, and that types of practitioners allowed to practice without direct supervision have delineated clinical privileges for those services.

ADA urges HCFA to provide more guidance regarding what constitutes a qualified provider and to include specific language regarding "qualified dietitian."

Supporting Discussion

ADA is concerned that while HCFA seeks to eliminate staffing and credentialing requirements for qualified dietitians, the agency explicitly "retains all of the nurse staffing requirements in current regulations." If HCFA is going to make global changes to require hospitals to defer to state licensure requirements, then the agency should make these recommendations across the board to all health care providers--not just certain subsets or professions. However, since HCFA did specifically ask for comments on this issue, ADA would like to address this issue.

ADA has consistently advocated state licensure laws which clearly delineate the educational and experiential qualifications for dietitians. Unfortunately, the laws which some states have passed vary greatly, have different and inconsistent enforcement mechanisms, and lack a standard scope of practice for nutrition professionals. In fact, 12 states have no statutory regulation of dietitians whatsoever. Therefore, deferring to state licensure laws regarding nutrition services will not assure quality nutrition care in the hospital setting and, could, in fact, jeopardize quality nutrition care for patients. This approach may also lead to inequities in the health care setting, with quality care being based more on where one receives care and less on proven standards of optimal care, including MNT.

ADA urges HCFA to incorporate the recommended changes regarding "qualified dietitians" and to define such terms in the regulation.

§482.15: Condition of participation: Patient admission, assessment, and plan of care.

Recommendation: clarify terminology and time lines.

(a) Standard: Admission and comprehensive assessment. (2) This section addresses the initial assessment. HCFA is proposing to set a standard that the initial assessment be done and placed into the medical record within 24 hours of admission.

ADA supports the need for timely assessments of patient status but would like additional clarification on this issue. Specifically, per current JCAHO standards, the screening assessment is required within 24 hours. If the screening criteria identifies a patient who is at high nutritional risk, a qualified individual--a dietitian--performs a more detailed follow-up assessment. The hospital determines the time frame requirements for this assessment. If HCFA's intent is similar to JCAHO standards, then this standard should be stated more clearly to assure that an initial nutrition screening is performed on all patients at the time the initial patient information is obtained, and patients identified to be at nutritional risk receive an assessment by a qualified individual--a dietitian--within an appropriate period of time, as determined by the hospital.

§482.20: Condition of participation: Patient care.

Recommendation: provide more guidance.

(b) Standard: Delivery of patient care. (3) Patient care services are provided in accordance with the order of practitioners who are qualified and have delineated clinical privileges as specified under §482.125(a). This section describes the need for Medicare patients to be under the care of an appropriately qualified practitioner.

ADA's comments previously provided regarding the definition of a qualified practitioner and state licensure laws apply to this section as well.

§482.25: Condition of participation: Quality assessment and performance improvement.

Recommendation: include "medical nutrition therapy" and use accurate terminology.

(a) Standard: Program scope. (1)(vii) Nutritional services, including patient's responses to therapeutic diets and parenteral nutrition, if used.

ADA commends HCFA for recognizing the importance of nutritional services as a component of the quality assessment and performance improvement system. However, ADA recommends that this standard be modified to more accurately reflect the health care environment and the role of medical nutrition therapy in patient outcomes and quality improvements. ADA recommends this standard to read as follows:

(1)(vii) Nutritional services, including patient responses to medical nutrition therapy, which may include enteral nutrition and parenteral nutrition (if used).

Supporting Discussion

Therapeutic diets and parenteral nutrition are just two of a myriad of MNT options that may be utilized in patient care. If the standard were to be implemented as HCFA has proposed, many patients at nutritional risk may not be identified through the quality assessment and performance improvement system and patient outcomes will be compromised.

ADA urges HCFA to look closely at the MNT protocols that ADA has developed (1,2) as well as the information provided in Appendix E on Nutrition Outcome Indicators, for examples of objective measures and protocols that hospitals should utilize when measuring, analyzing, and tracking quality indicators. ADA has a team of health services research advisors with expertise in the development of nutrition indicators and quality review criteria. These experts are available to work with HCFA on refining the use of indicators of nutrition care as well as developing nutrition indicators for other population groups such as pediatric patients.

CONCLUSION

The ADA is pleased to provide input on these important issues. ADA supports the need for regulations that focus on the patient and patient outcomes. Cost-effective, quality care, including appropriate nutrition services, must be ensured with inclusion of qualified nutrition professionals such as registered dietitians, specified in the regulations.

In other health care settings such as long term care and end stage renal disease facilities, HCFA has successfully recognized the critical role of the RD. ADA strongly believes that ensuring all patients equal access to necessary MNT services must be considered in the development of a final rule for hospitals. HCFA policies for health care in various settings must be harmonized at the highest common denominator to achieve the goals of improved outcomes, patient satisfaction, and equal access to quality health care.

HCFA has provided no evidence that current policies governing nutrition services in the hospital setting are creating problems or compromising optimal health outcomes. Furthermore, research indicates that nutritional services as provided by qualified nutrition professionals are essential to achieving HCFA's goals of improving patient outcomes in a cost-effective manner. While the proposed rule recognizes the importance of providing flexibility to hospitals, such a strict interpretation of "outcomes," without recognition of the appropriate health care professional who will produce positive outcomes, may actually result in suboptimal care and unnecessary health care spending.

Thank you for your consideration of these recommendations. We stand ready to provide HCFA with additional information and consultation as the final rule is developed.

Sincerely,

Polly A. Fitz, MA, RD
President

Appendix A
Appendix B
Appendix C
Appendix D
Appendix E

1. The American Dietetic Association and Morrison Health Care, Inc. Medical Nutrition Therapy Across the Continuum of Care. 1st ed. Chicago, Ill: The American Dietetic Association;1996.
2. The American Dietetic Association and Morrison Health Care, Inc. Medical Nutrition Therapy Across the Continuum of Care: Supplement 1. Chicago, Ill: The American Dietetic Association;1997.
3. Lazarou J, Pomeranz B. Incidence of adverse drug reactions in hospitalized patients. JAMA. 1998;279:1200-1205.
4. Whelton PK, Appel LJ, Espeland MA, Applegate WB, Ettinger WH, et al. Sodium reduction and weight loss in the treatment of hypertention in older persons. JAMA. 1998;279:839-846.
5. Barrett S. Why "nutritionist" licensing is important. Accessed April 20, 1998.
6. Comprehensive Accreditation Manual for Hospitals. Oakbrook Terrace, Ill: Joint Commission on Accreditation of Healthcare Organizations; 1998.
7. Gottschlich MM, Mayes T, Khoury JC, Warden GD. Significance of obesity on nutritional, immunologic, hormonal, and clinical outcome parameters in burns. J Am Diet Assoc. 1993;(93)1261-1268.
8. Gottschlich MM, Jenkins M, Warden GD, Baumer T, havens P, Snook JT, Alexander W. Differential effects of three enteral dietary regimens on selected outcome variables in burn patients. JPEN. 1990;14:225-236.
9. Ireton-Jones C, Gottschlich MM, Bell SJ. Practice Oriented Nutrition Research: An Outcomes Measurement Approach. Aspen Publishers, eds. 1998.
10. Dietary Reference Intakes: Calcium, phosphorus, magnesium, vitamin D, and flouride. A report of the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes. Institute of Medicine, Food and Nutrition Board. Washington, DC. National Academy Press, 1997.
11. Dietary Reference Intakes: Thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, pantothenic acid, biotin, and choline. A report of the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes. Institute of Medicine, Food and Nutrition Board. Washington, DC. National Academy Press, 1998.

Letters Supporting ADA's Position on HCFA's Proposed Rule on Hospital Conditions of Participation

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