August 15, 2016
Centers for Medicare & Medicaid Services
Department of Health and Human Services
P.O. Box 8010
Baltimore, MD 21244
Re: Medicare and Medicaid Programs; Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care (CMS-3295-P)
Dear Mr. Slavitt,
The Academy of Nutrition and Dietetics (the "Academy") appreciates the opportunity to submit these comments to the Centers for Medicare and Medicaid Services (CMS) at the Department of Health and Human Services (HHS) regarding its proposed rule "Medicare and Medicaid Programs; Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care (CMS-3295-P)." Representing more than 100,000 registered dietitian nutritionists (RDNs),1 nutrition and dietetic technicians, registered (NDTRs), and advanced-degree nutritionists, the Academy is the largest association of food and nutrition professionals in the United States and is committed to improving the nation’s health through food and nutrition across the lifecycle. Every day we work with Americans in all walks of life — from prenatal care through end of life care — providing nutrition care services and conducting nutrition research.
The Academy largely supports CMS's proposed changes intended to "modernize hospital and critical access hospital (CAH) requirements, improve quality of care, and support HHS and CMS priorities[, including] reduced incidence of hospital-acquired conditions (HACs)." The Academy has serious concerns about the regulatory language and evidentiary basis regarding allowing non-RDN nutrition professionals to order therapeutic diets.
A. Ordering of Therapeutic Diets
The Academy enthusiastically supports revising existing CAH Conditions of Participation to allow authorized RDNs to independently order and modify patient diets. We agree with CMS "that a team-based approach that allows for professionals to practice in their area of expertise and to the fullest extent allowed by state law would be of great benefit to CAH patients . . . [and] that patients in these traditionally underserved areas deserve the same standard of care as patients receive in better-served areas." RDNs’ training and education best qualifies them to order patient diets both initially upon admission and after a nutrition assessment that considers the connection between a patient's complex medical problems, nutrition status, and actual nutrition risk. RDNs authorized to order patient diets are more likely to conform the wording of their diet orders to the formulary, eliminating confusion that has frequently resulted in food service workers serving the wrong diet.
CMS indicates its "intention is to include all qualified dietitians and other clinically qualified nutrition professionals," but — much like the term "Licensed Independent Practitioner" discussed earlier in the proposed rule2 — neither of the terms "qualified dietitians" or "clinically qualified nutrition professionals" are used in the Social Security Act, nor in any other federal law. Only the "registered dietitian nutritionist" credential has the consistent, necessary qualifications and standards of practice and professional performance to ensure competence in ordering therapeutic diets among potential nutrition professionals.3 CMS here proposes to abandon existing federal standards endorsed by the National Academy of Medicine (formerly the IOM)4 and instead demand each state take responsibility for setting new, licensure and regulatory standards that will inevitably vary widely across the fifty states. States will be obligated to create a second regulatory scheme simply because state licensure laws set a minimum level of qualifications that do not ensure the non-RDN licensee is even qualified to order therapeutic diets. CMS appears to misapprehend states' regulation of dietetics and nutrition professionals. It is not merely that "some States elect not to use the regulatory term ‘registered' and choose instead to use the term ‘licensed' (or no modifying term at all)," but that those terms often have fundamentally different meetings from one another and imply different qualifications and competencies.
CMS combines its failure to specify any of the critically necessary qualifications for providers permitted to order therapeutic diets with an unsupported assertion that states "recognize other nutrition professionals with equal or possibly more extensive qualifications." The Academy unequivocally asserts that no state recognizes or licenses any nutrition professional with greater competency or qualifications than the registered dietitian nutritionist in ordering therapeutic diets. Although some states do license certain other nutrition practitioners who may either have advanced degrees or different credentials, there is generally no state requirement that these often-specious degrees are minimally from accredited academic programs, meaning these licensed individuals do not meet the single existing federal standard for practice specified in 42 U.S.C. 1861(vv)(2). We are concerned that CMS does not recognize the fact that many licensed nutrition professionals (and indeed, even many "licensed dietitians" who are not RDNs) have definitively not "benefited from curriculums that devote a significant number of educational hours to this area of medicine." Troublingly, instead of relying upon the existing statutory definition of "registered dietitian or nutrition professional," CMS proposes here to disregard federal law in the hope that states will pick up the slack and pass new laws setting (unspecified) qualifications detailing which of their various licensed nutrition professionals are competent to order therapeutic diets.
As CMS notes in reviewing the professional literature on the subject, RDNs "are the professionals who are best qualified to assess a patient's nutritional status and to design and implement a nutritional treatment plan in consultation with the patient's interdisciplinary care team." Yet CMS inexplicably is now ignoring the entirety of its cited evidence, which is specific to RDNs, and would instead allow multiple other, differently qualified providers to order therapeutic diets simply because a state licenses them to provide wholly different, less complex nutrition services. CMS simply cannot cite "extensive training and education in nutrition that RD[N]s experience" to defend extending complex clinical privileges to non-RDNs who do not obtain the same evidence-based training. If there is, in fact, evidence suggesting that non-RDN nutrition professionals "provide timely, cost-effective, and evidence-based nutrition services as the recognized experts on a CAH interdisciplinary team," it might be appropriate to extend expanded privileges to them; in the absence of any evidence to that effect, it is fundamentally irresponsible and dangerous to do so. This capricious proposal to extend ordering privileges to non-RDNs has no evidentiary basis, is likely to cause harm to patients, and would require state and regulatory agencies across the country to undertake lengthy and otherwise unnecessary remedial initiatives. We urge CMS to reconsider this element of its proposed rule, draft new language that accords with the very evidence CMS cites, and instead ensure that only RDNs or those qualified nutrition professionals meeting existing federal standards with actual training in ordering therapeutic diets are newly eligible to order them.
Specifically, the Academy recommends that CMS define "qualified dietitian" consistent with the definition of "registered dietitian or nutrition professional" in §1861(vv)(2) of the Social Security Act. The Social Security Act's definition appropriately requires third-party objective accreditation of dietetics and nutrition programs and curricula, recognizing that the mere accreditation of a college of university in no way ensures that graduates have obtained the skills, education, and training necessary to protect the public and achieve the beneficial patient outcomes noted in the proposed rule. Notably, the Social Security Act properly recognizes that unlicensed RDNs in states that choose not to license "registered dietitians or nutrition professionals" are still qualified providers under federal law and should be eligible to order patient diets under the proposed rule absent specific, directly countervailing state law.
The Academy supports the proposed requirement that "all patient medical records must document discharge and transfer summaries with outcomes of all hospitalizations, disposition of cases, and provisions for follow-up care for all inpatient and outpatient visits to reflect the scope of all services received by the patient." We agree that "these changes would clarify the importance of discharge summaries for patients being transferred to post-acute care facilities such as nursing homes or inpatient rehabilitation facilities."
RDNs play a critical role in transitions of care for individuals for whom nutrition is a particularly essential part of their plan of care. Under-nutrition and/or poor diet compliance may contribute to negative outcomes in residents or patients with pneumonia, acute myocardial infarction and heart failure and increase the likelihood of hospital readmission.5,6,7 Collaboration among health care professionals — including RDNs — is critical to successful post-acute transitional care plan development and implementation.
The Academy encourages CMS to include specific data elements in transitions of care requirements, including:
- Therapeutic diet order and oral nutrition supplement order history, including present use/status;
- Enteral and parenteral nutrition orders;
- Oral intake history and acceptance of diet;
- Food allergies and/or intolerances;
- Food preferences, special diet restrictions, and other specific individualized needs to ensure accommodation is possible;
- Diet education the patient and/or family has received in the past;
- Ability to swallow and/or chew, conditions of teeth, and any need for texture modifications;
- Pertinent height and weight history and any pertinent trends;
- Progress notes completed during hospitalization;
- Skin integrity, such as the presence and history of pressure ulcers and wounds;
- Lab levels, including CRP level; and
- Those in value sets in the National Library of Medicine's Value Set Authority Center created by the steward "AND," an acronym for the Academy of Nutrition and Dietetics.
The Academy respectfully suggests a number of additional strategies for improving transition and discharge planning to help prevent hospital readmissions and improve quality of life across the continuum of care. At the outset, Medical Nutrition Therapy (MNT) and other nutrition education should not just include the patient, but the family and/or caregiver as well. Too often, nutrition education at discharge is limited to providing the patient a sheet from the diet manual. Discharge planning should include telephonic monitoring and follow-up care, including follow-up with community-based services, such as Meals on Wheels, local senior centers, and home care planning (e.g., ability to procure, cook, and eat food and who can assist with these tasks if needed). MNT must be provided that meets the client's cultural and food preferences, budget constraints, and ensures that the client has the skills and tools to monitor his/her own progress, such as scales for weight monitoring and glucometers for blood glucose monitoring.
C. Quality Assessment and Performance Improvement (QAPI) Programs
CMS details at length the new Quality Assurance and Performance Improvement (QAPI) requirements and includes recommendations for the utilization of electronic health records, common clinical data sets, and other health IT components to improve care and transitions of care throughout assessments and care plans. The Academy has long been a strong supporter of CMS's QAPI initiatives and we are committed to eliminating burdensome red tape that prioritizes documentation of care over actual provision of care. Performance improvement is critical, because ultimately the patient's or resident's quality of life is at stake.
The proposed QAPI changes would shift from the existing requirements' reactive focus of taking corrective action once a problem is identified to "proactively maximiz[ing] quality improvement activities and programs. . . ." RDNs are participating in QAPI programs in numerous hospital and long term care facilities across the country, which is helping to prevent and reduce adverse events for patients and residents. We remain committed to "providing the right service at the right time in the right way," and support CMS's proposal to require CAHs "to develop, implement, and maintain an effective, ongoing, facility-wide, and data-driven QAPI program."
The Academy supports QAPI efforts to "systematically examine the quality of its services and implement specific improvement projects on an ongoing basis." QAPI programs can help hospitals distinguish and avoid mistakes, improve health outcomes, and otherwise prevent and reduce medical errors. Effective use of data related to hospital readmissions and hospital-acquired conditions is particularly valuable. We also agree with CMS that the use of certified health IT to transmit interoperable data can enable more robust care coordination. As CMS notes, hospitals are "already collecting and reporting quality measures data for these programs," making it efficient and cost-effective to include this data in QAPI programs.
Consequences of under nutrition include increased mortality, loss of strength, depression, lethargy, immune dysfunction, pressure ulcers, delayed recovery from illness, increased chance of hospital admission, and poor wound healing.8 Older adults are at higher risk for pressure ulcer development due to age, lack of mobility, skin frailty, unintended weight loss, and other factors. Although pressure ulcers have multiple causes, poor nutritional status is a contributing factor and is an important aspect of prevention.9 RDNs are skilled and effective at preventing and resolving these complications.
Audits and systematized assessments that include collecting and assessing relevant nutritional status parameters (e.g., lab values, weights and weight trends, skin integrity, dysphagia interventions, therapeutic diets, use of nutritional supplements, and meal/fluids intake and tolerance) enable facilities to determine opportunities for improvement. Our members report that existing QAPI teams have been both educational for the staff and beneficial for patients, because they require a facility to act in a collaborative and interdisciplinary manner to make necessary improvements. The Academy is supportive of the proposed QAPI requirements.
D. Antibiotic Resistance/Stewardship
The Academy supports CMS's proposed "revisions that would require a hospital to develop and maintain an antibiotic stewardship program as an effective means to improve hospital antibiotic-prescribing practices and curb patient risk . . . ." These revisions are likely to "improve  internal coordination among all components responsible for antibiotic use and [to] reduc[e] the development of resistance . . . ." We also support CMS's proposed "requirement for hospitals to promote evidence-based use of antibiotics, and to reduce the incidence of adverse consequences of inappropriate antibiotic use . . . ." Adherence to nationally recognized guidelines will provide hospitals with sufficient flexibility to adopt policies that work for them and for patients.
E. Discriminatory Behavior
The Academy supports CMS's proposal to enhance civil rights by eliminating perceived and actual barriers to care, thereby reducing adverse outcomes for patients. Enhanced, explicit protections regarding hospital the patient's gender identity, religion, race, color, national origin, sex, age, disability, and sexual orientation may ameliorate denials of service and inadequate care and paying heed to these are in the interest of the patient's health and safety.
The Academy sincerely appreciates the opportunity to offer comments on the proposed changes to Critical Access Hospitals, and we would welcome the opportunity to discuss the above issues—particularly our concerns with proposed regulatory language that will enable inadequately trained individuals to order therapeutic diets without significant state action—with CMS in the near future. Please contact either Jeanne Blankenship by telephone at 312/899-1730 or by email at email@example.com or Pepin Tuma by telephone at 202/775-8277, ext. 6001 or by email at firstname.lastname@example.org with any questions or requests for additional information.
Jeanne Blankenship, MS, RDN
Policy Initiatives and Advocacy
Academy of Nutrition and Dietetics
Pepin Andrew Tuma, Esq.
Government & Regulatory Affairs
Academy of Nutrition and Dietetics
1 The Academy recently approved the optional use of the credential "registered dietitian nutritionist (RDN)" by "registered dietitians (RDs)" to more accurately convey who they are and what they do as the nation's food and nutrition experts. The RD and RDN credentials have identical meanings and legal trademark definitions.
2 CMS quotes the American Association of Physician Assistants in the proposed rule: "‘Licensed Independent Practitioners' is not a term used in the Social Security Act, nor in any other federal law" and that "the LIP terminology is, at best, confusing regarding physician assistants' ability to order; at worst; it restricts the ability of hospitals to utilize PAs to the extent of their educational preparation and scope of practice, as determined by state law."
3 Attached as Appendix A, find Brantley SL, Russell MK, Mogensen KM, et al. American Society for Parenteral and Enteral Nutrition and Academy of Nutrition and Dietetics: revised 2014 standards of practice and standards of professional performance for registered dietitian nutritionists (competent, proficient, and expert) in nutrition support. J Acad Nutr Diet. 2014;114(12):2001-8.e37.
4 Committee on Nutrition Services for Medicare Beneficiaries. "The Role of Nutrition in Maintaining Health in the Nation's Elderly: Evaluating Coverage of Nutrition Services for the Medicare Population." Washington, DC: Food and Nutrition Board, Institute of Medicine; January 1, 2000 (published) ("[The registered dietitian is currently the single identifiable group of health-care professionals with standardized education, clinical training, continuing education and national credentialing requirements necessary to be directly reimbursed as a provider of nutrition therapy.")
5 Hoyt RE, Bowling LS. Reducing readmissions for congestive heart failure. Am Fam Physician. Apr 15 2001;63(8):1593-1598.
6 Paterna S, Parrinello G, Cannizzaro S, et al. Medium term effects of different dosage of diuretic, sodium, and fluid administration on neurohormonal and clinical outcome in patients with recently compensated heart failure. Am J Cardiol. Jan 1 2009;103(1):93-102.
7 Krumholz HM. Post-hospital syndrome--an acquired, transient condition of generalized risk. N Engl J Med. 2013;368(2):100-2.
8 Challa S, Sharkey JR, Chen M, Phillips CD. Association of resident, facility, and geographic characteristics with chronic undernutrition in a nationally represented sample of older residents in U.S. nursing homes. J Nutr Health Aging. 2007;11:179-184.
9 Dorner B, Posthauer ME, Thomas D. The role of nutrition in pressure ulcer prevention and treatment: National Pressure Ulcer Advisory Panel white paper. Advance Skin Wound Care. 2009;22:212-221.