Academy April 2013 Comments to CMS Part II Reg Provisions

April 8, 2013

Marilyn Tavenner, MS RN
Centers for Medicare and Medicaid Services
Department of Health and Human Services
P.O. Box 8010 Baltimore, MD 21244–8010

Re: CMS-3267-P (Medicare and Medicaid Programs; Part II--Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction)

Dear Ms. Tavenner:

The Academy of Nutrition and Dietetics (the "Academy"), formerly the American Dietetic Association, is pleased to comment on the proposed rule "Medicare and Medicaid Programs; Part II--Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction" (CMS-3267-P) published February 7, 2013.

The Academy is the world’s largest organization of food and nutrition professionals, with more than 74,000 members comprised of registered dietitians (RDs), dietetic technicians, registered, and advanced-degree nutritionists. Every day we work with Americans in all walks of life — from prenatal care through old age — providing nutrition care. We are committed to improving the nation’s health through food and nutrition and providing medical nutrition therapy (MNT)1 and other evidence-based nutrition counseling services that meet the health needs of all citizens.

The Academy enthusiastically supports CMS's proposed reformation of excessively burdensome regulations to allow authorized RDs to independently order and modify patient diets and order necessary nutrition-related laboratory tests to monitor the effectiveness of nutrition plans and diet orders. As CMS notes, the proposed rule will "[s]ave hospitals significant resources by permitting registered dietitians to order patient diets independently, which they are trained to do, without requiring the supervision or approval of a physician or other practitioner." (Emphasis added.) In addition, the Academy supports the proposed rule's explicit recognition that RDs "have equally important roles to play on a medical staff and on the quality of medical care provided to patients in the hospital" and is pleased to offer the below recommendations for reforms to other burdensome, inefficient, Conditions of Participation (CoPs).

In order to better support an efficient, accurate diet order process, the Academy has worked for the past three years within Health Level Seven (HL7) processes to create, ballot and implement the HL7 v3 Nutrition Orders Clinical Messages project. This project, approved by HL7 in July 2012, will use the previously balloted HL7 Diet and Nutrition Orders Domain Analysis Model2 to develop technical messaging specifications to support the meaningful exchange of electronic nutrition order clinical messages including standardized diet terminology. The combination of these two projects will allow for consistent standardized diet orders for use in electronic health records and across all transitions and areas of care.

The Academy urges CMS to adopt a final rule ensuring qualified RDs may independently:

  • Order all patient diets, including therapeutic diets;
  • Order both standard house and disease-specific nutrition supplements;
  • Order enteral nutrition, parenteral nutrition, or complex infant formulas;
  • Order nutrition-related laboratory tests needed to inform nutrition decisions and orders;
  • Order therapeutic diets in states that do not license RDs if granted ordering privileges by the hospital governing board or appointed to the medical staff.

Hospital RD Ordering Privileges

Rationale

The proposed rule recognizes RDs as the "recognized nutrition experts on a hospital interdisciplinary team" and authorizes a practical and accountable mechanism for efficaciously ordering patient diets in hospitals. RDs' training and education best qualifies them to order patient diets both initially upon admission and after a nutrition assessment that considers the connection between patients' complex medical problems, nutrition status, and actual nutrition risk. The Academy agrees with CMS's conclusion that "hospitals that choose to grant these specific ordering privileges to RDs may achieve a higher quality of care for their patients by allowing these professionals to fully and efficiently function as important members of the hospital patient care team in the role for which they were trained." The studies cited in the proposed rule confirm that the revised §482.28(b)(2) will produce substantial cost savings, allow RDs to see and treat more patients, and reduce delays in the ordering of therapeutic diets (including nutritional supplements), particularly parenteral nutrition (PN) and enteral nutrition (EN) diet orders, complex infant formula orders, and in the monitoring of associated lab parameters. The growing number of RDs with advanced/terminal degrees and specialized credentials is likely to produce even greater benefits as these dietetics experts perform at the height of RD scope of practice.

Because RDs have a limited time to improve a patient's status during hospitalization, the Academy welcomes the proposed rule change that will facilitate RDs' abilities to influence critical patient outcomes. Malnutrition is prevalent among hospital patients, with studies showing between 20%-50% of patients may be malnourished.3,4 Decreased nutrient intake is a major independent risk factor for in-hospital mortality and assistance from across the hospital interdisciplinary team is essential to assuring adequate consumption of nutrients. Studies show in-hospital mortality is highest in the patients "in the lowest BMI group (<18.5 kg/m2), increasing further when the proportion of plated food eaten was reduced and [again] increasing further when no snacks were taken."5 Use of oral nutrition supplements as snacks and substitutions "decreases length of stay, episode cost, and 30-day readmission risk in the inpatient population.6 Food is the bedrock of treatment for malnourished hospital patients, and the Academy encourages CMS to consider handling RD-provided nutrition care, assessments, and interventions in a similar manner to other professional services provided as part of an inpatient stay.7The Academy surveyed members about their experiences practicing pursuant to the existing restrictive regulation precluding RDs from independently ordering patient diets and identified several recurrent themes:

  • Patients' nutrition needs are not always fully addressed upon admission, frequently requiring concomitant changes in diet orders that are often excessively delayed when RDs must wait for a physician to effectuate the order.
  • Timely nutrition interventions and ongoing monitoring of nutrition status by RDs facilitates earlier discharge, producing substantial cost savings by shortening lengths of stay.8
  • Patients suffer unnecessary complications and delay in care under the existing rule when RDs are prevented from independently changing nutritional supplements, liberalizing a diet for better intake, initially assessing appropriate diets for patients with food allergies, or changing diet consistency for patients with dysphagia, an inability to chew food, or at risk of aspiration.
  • "Swingbed" patients, who may only see a physician once a week, experience particularly significant delays as their health conditions and nutrition needs change.
  • RDs 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.
  • Pediatric patients may be harmed from delays in ordering appropriate infant formula that could be ameliorated if the proposed rule is finalized.
  • The Academy would be pleased to share with CMS results of its recent surveys of members, documenting specific examples of patient harm and the increased costs of complying with the existing restrictive rule. The Academy looks forward to working with CMS as it develops new interpretive guidelines and surveyor trainings to ensure consistency among surveys and to avoid any potential misinterpretations of the proposed rule by federal, state, or accreditation entity surveyors.

Oversight and Authorization Processes

The proposed language of §482.28(b)(2) would allow a "qualified dieti[t]ian as authorized by the medical staff and in accordance with State law" to order patient diets, including therapeutic diets. "Qualified dietitians" (as discussed below) could be authorized after an individualized assessment of their competence leads hospitals to conclude that they possess the requisite education and abilities in accordance with state law. The Academy notes that not all registered dietitians will seek these privileges and some RDs authorized to independently order diets may instead seek a physician's order in some circumstances (e.g., critical patients, determining a patient's NPO status).

The Hospital CoPs detail the tiered oversight and authorization process through which physician and non-physician practitioners (including RDs) may be either (1) appointed to the medical staff, (2) granted formal medical staff privileges to practice at the hospital by the governing body for specific activities within their State scope of practice without being appointed to the medical staff, or (3) authorized by the medical staff to perform certain pre-approved tasks without going through the aforementioned formal privileging process. The proposed rule rightly makes hospital governing boards and medical staffs responsible for oversight, as these entities can best assess practitioners' abilities and are incentivized to ensure safe, cost-effective, and efficient care.

As discussed further below, some state surveyors will not permit RDs to become privileged without a state dietetics licensure board or some federal oversight board, citing a CMS Survey and Certification Group Memorandum of 12 November 2004.9 In this proposed rule, CMS rebuts that misinterpretation of federal regulatory intent, concluding that the existing tiered oversight and authorization options are sufficient to ensure patient safety and practitioner competency:

In order for patients to have access to the timely nutritional care that can be provided by RDs, a hospital must have the regulatory flexibility either to appoint RDs to the medical staff and grant them specific nutritional ordering privileges or to authorize the ordering privileges without appointment to the medical staff, all through the hospital’s appropriate medical staff rules, regulations, and bylaws. In either instance, medical staff oversight of RDs and their ordering privileges would be ensured. [Emphasis added.]

Defining "Qualified Dietitian"

Anticipated benefits to patient care and associated cost savings can only be realized if CMS retains high standards and qualifications of competency and training for qualified dietitians. State licensure laws in some states set minimum qualifications for licensed dietitians substantially below that calculated to achieve the cost savings and improved patient outcomes anticipated under this rule, making it necessary that CMS define "qualified dietitian" in §482.28(b)(2) to be consistent with other CMS-adopted definitions to ensure patients' health and safety. Because state licensure merely sets the minimum standard to practice dietetics and nutrition (as a "licensed dietitian," "licensed dietitian nutritionist" or a similar such title), it cannot, by itself, be assumed to indicate the licensee has the training and competencies required to be a "qualified dietitian" under federal law and regulation.

In the interest of achieving the anticipated cost -savings and improved patient outcomes, the Academy urges CMS to definitively adopt the definition of "qualified dietitian" in §482.94(e) ("A qualified dietitian is an individual who meets practice requirements in the State in which he or she practices and is a registered dietitian with the Commission on Dietetic Registration."), which is the only regulatory definition for "qualified dietitian" in the broader Hospital CoPs (42 CFR 482 et seq.). Alternatively, 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 (42 U.S.C. 1395(x)(vv)(2)). The Social Security Act definition rightly requires third-party objective accreditation of dietetics and nutrition programs and curricula, recognizing that the mere accreditation of a college or 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 as a qualified provider. Notably, the Social Security Act properly recognizes that "non-licensed," "registered dietitians" in states that choose not to license "registered dietitians or nutrition professionals" are still qualified providers under federal law and would be eligible to order patient diets under the proposed rule absent specific, directly countervailing state law.

Defining "Therapeutic Diet"

CMS "propose[s] to update terminology related to ‘diets’ and ‘therapeutic diets’ in the CoPs." There is presently no definition in the Hospital CoPs for "therapeutic diet," and the Academy encourages CMS to uniformly adopt the definition of "therapeutic diet" that CMS has recently adopted for other care settings:

A diet intervention ordered by a health care practitioner as part of the treatment for a disease or clinical condition manifesting an altered nutritional status, to eliminate, decrease, or increase certain substances in the diet (e.g., sodium, potassium).10

The practical implications for defining and ordering therapeutic diets are consistent across the continuum of care. The Academy also encourages CMS to uniformly adopt its most recent interpretive coding guidelines for understanding therapeutic diets across the continuum of care. These guidelines help clarify what constitutes a "supplement" and a "mechanically altered diet"11 for coding purposes on the MDS:

Therapeutic diets are not defined by the content of what is provided or when it is served, but why the diet is required. Therapeutic diets provide the corresponding treatment that addresses a particular disease or clinical condition which is manifesting an altered nutritional status by providing the specific nutritional requirements to remedy the alteration. [Emphasis in original.]

A nutritional supplement (house supplement or packaged) given as part of the treatment for a disease or clinical condition manifesting an altered nutrition status, does not constitute a therapeutic diet, but may be part of a therapeutic diet. Therefore, supplements (whether given with, in-between, or instead of meals) are only coded in K0510D, Therapeutic Diet when they are being administered as part of a therapeutic diet to manage problematic health conditions (e.g. supplement for protein-calorie malnutrition).12 [Emphasis in original.]

The Academy agrees with CMS that a therapeutic diet is best defined by why it is served; a regular diet becomes a therapeutic diet only at the nexus of a particular disease or clinical condition and the corresponding treatment that includes a specific nutritional requirement, including parenteral and enteral nutrition. Accordingly, all impacted CMS CoPs should ensure that qualified registered dietitians should be able to provide nutritional supplements as snacks and substitutions (without necessarily joining the medical staff or obtaining privileges or authorization from the governing board) unless those supplements are specifically intended as a part of a particular treatment regimen.

Cost Savings

One goal of Executive Order 13563 is "freeing up resources that health care providers, health plans, and States could use to improve or enhance patient health and safety." CMS proposed this rule because "[t]he addition of ordering privileges enhances the ability that RDs already have to provide timely, cost-effective, and evidence-based nutrition services as the recognized nutrition experts on a hospital interdisciplinary team and saves valuable time in the care and treatment of patients, time that is now often wasted as RDs must seek out physicians, APRNs, and PAs to write or co-sign dietary orders." The literature accords with CMS that even conservative estimates of the potential cost savings associated with freeing up these resources are substantial; less conservative assumptions could realize even more than the anticipated $528 million in annual savings.13

There are particularly significant cost savings when RDs order and monitor parenteral nutrition (PN) usage. The appropriate selection of route of nutrition support (i.e., enteral nutrition (EN) versus PN) can be associated with decreased complications and mortality rates. It also decreases costs; CMS references the Peterson et al study noting a 50% reduction in inappropriate PN usage during pre - and post-ordering privilege periods produces a 20% cost savings in PN usage totaling $300,000 over two years for a single hospital.14

Winchester (VA) Medical Center, where RDs have been approving PN and writing the orders as "verbal per physician request" since December 2010, has recently seen similar cost savings by significantly reducing its inappropriate PN usage. Active engagement and autonomy of RDs resulted in an annual savings of $841,282.00 (2012 usage compared to 2009 usage) for this single hospital. Cost savings (assuming at least a five day course of therapy) are realized from reductions in multiple areas: lab monitoring, central line and supplies, RD/RN/IV therapy and pharmacy labor, and TPN bag/tubing/additives.15 When RDs are able to enter the therapeutic diet order, nutrition delays are reduced and fewer burdens are placed on providers.

Privileging in States Choosing Not to License RDs

The proposed rule highlights a troubling problem the Academy has previously raised with CMS necessitating this regulatory reform: some state surveyors have (mis)interpreted existing CoPs and guidelines to preclude RDs in states without licensure from becoming privileged to order patient diets, resulting in a chilling effect on the appropriate granting of hospital privileges. California hospitals in particular have been reticent to grant RDs clinical privileges after being fined and tagged by surveyors, despite acting consistent with CMS guidance. The Academy agrees with CMS "that the regulatory language and the [interpretive guidelines] for §482.28(b) are too restrictive and lack the reasonable flexibility to allow hospitals to extend these specific privileges to RDs in accordance with State laws."

The Academy requests that the Survey and Certification Group issue a guidance memorandum confirming there is no controlling federal law, regulation, or Survey and Certification Group interpretive memorandum that would either (1) preclude a hospital from authorizing or privileging a competent, qualified registered dietitian from ordering patient diets in hospitals in a state that does not license dietitians or (2) require an additional federal or state oversight entity other than the hospital governing board or medical staff referred to in the proposed rule absent a specific, directly countervailing state law.16

Professional licensure is generally a State domain and is not independently required by the CoPs for practitioners in those states with laws requiring licensure:
  • Section 482.28(a)(2) of the Hospital CoPs defines a "qualified dietitian" in the hospital setting, providing that "[q]ualification is determined on the basis of education, experience, specialized training, State licensure or registration when applicable, and maintaining professional standards of practice."17 (Emphasis added.)
  • In the "Survey Procedures" section of the Hospital CoPs, surveyors are to "[r]eview the dietitian’s personnel file to determine that he/she is qualified based on education, experience, specialized training, and, if required by State law, is licensed, certified, or registered by the State."18 (Emphasis added.)
  • The interpretive guidelines for §482.11(c) state, "All staff that are required by the State to be licensed must possess a current license. The hospital must assure that these personnel are in compliance with the State’s licensure laws. The laws requiring licensure vary from state to state." (Emphasis added.)
No federal provision specifically requires a registered dietitian to become licensed to be a "qualified dietitian" unless state law — not just a state agency’s conflicting interpretation of federal regulations or guidance — requires state licensure or certification. CMS proposed the rule "to provide the flexibility that hospitals need under federal law to maximize their medical staff opportunities for all practitioners, but within the regulatory boundaries of their State licensing and scope-of-practice laws." In states without any relevant regulatory boundaries (such as choosing not to license dietitians), federal law controls to enable hospitals to exercise the flexibility CMS affirms they need to "meet the needs of their patients most efficiently and effectively."

Clarity from CMS on this issue as the proposed rule is finalized is critical, because, "[w]ithout the proposed regulatory changes allowing [hospitals] to grant appropriate ordering privileges to RDs, hospitals would not be able to effectively realize the improved patient outcomes and overall cost savings that we believe would be possible with such changes." CMS unambiguously states that "[i]n order for patients to have access to the timely nutritional care that can be provided by RDs, a hospital must have the regulatory flexibility either to appoint RDs to the medical staff and grant them specific nutritional ordering privileges or to authorize the ordering privileges without appointment to the medical staff, all through the hospital’s appropriate medical staff rules, regulations, and bylaws." (Emphasis added.)


RD ORDERING OF PATIENT DIETS ACROSS THE CONTINUUM OF CARE

CMS Should Permit RDs to Order Therapeutic Diets in Long Term Care (LTC)

As part of its efforts to create a streamlined, effective, and efficient regulatory framework designed to promote economic growth, innovation, job creation, and competitiveness, CMS should revise §483.35(e) to allow qualified, registered dietitians to order therapeutic diets in LTC settings such as nursing homes, rehabilitation settings, transisitional and subacute care, long term acute care (LTAC), assisted living, rest homes, and home health care. Allowing RDs in LTC facilities to order patient diets is particularly important, because they are frequently the only regularly available practitioner competent to modify diets in changed circumstances. Most nursing homes have limited physicians or mid-level practitioners on-site, and current practice requires diet order changes to be delayed until the physician can be reached for approval. The delay in care in LTC facilities is particularly problematic; necessary diet modifications may not happen in a timely manner, the risk of malnutrition increases, and costly hospital readmissions become more likely.

Medical directors working with a facility's Quality Assurance and Performance Improvement (QAPI) Steering Committee could supervise a formal credentialing process that would provide the necessary oversight for RDs in LTC facilities "to order patient diets independently, which they are trained to do, without requiring the supervision or approval of a physician or other practitioner." This proposed prior-approval credentialing process includes three elements:

  • Review of the registered dietitian's experience, credentials, and competency by the facility’s medical director and QAPI committee, with diet order writing approval granted;
  • Supervision of the dietitian's activities for three months with monitoring of continuing education; and
  • Data collection and quality chart review (potentially using tracer method or RD to RD peer chart review) to determine outcomes improvement in relevant areas, including reduction of unintended weight loss, improved healing of pressure ulcers, decreased incidence of readmissions to hospitals, decreased lengths of stay, and identification of other nutrition-related complications for residents and rehabilitation patients.

Therapeutic Diets versus Nutritional Supplements

Therapeutic diets in LTC facilities are by definition limited to diets in which specific changes in the consistency, texture, or nutrient make-up of one's diet are ordered because they directly correlate to treatment of one's particular disease or clinical condition.19 In other words, changes to a resident's diet that have no bearing on the treatment for her disease or clinical condition cannot by definition constitute a therapeutic diet, regardless of the ordering practitioner. Accordingly, the Academy urges CMS, consistent with existing LTC CoPs and interpretive guidelines, to clarify that RDs in LTC facilities may order and provide certain nutritional supplements for residents without those supplements being deemed part of a "therapeutic diet."

Nutritional supplements are defined in the LTC Conditions of Participation (CoPs) as "products that are used to complement a resident's dietary needs (e.g., total parenteral products, enteral products, and meal replacement products)."20 Nothing in the federal regulations or associated interpretive guidelines suggests, let alone requires, that provision of nutritional supplements by itself would place a resident or patient ipso facto on a therapeutic diet, because nutritional supplements are provided for reasons other than treatment for a disease or clinical conditions. In fact, CMS already recognizes that not all nutritional or dietary supplements are part of a therapeutic diet. A CMS Memorandum dated 28 September 2007 detailing whether and how to calculate an LTC facility's medication error rate specifically recognizes that there are "nutritional and/or dietary supplements that are not administered according to physician's orders."21

The lack of a uniform CMS definition for therapeutic diet combines with certain ambiguous interpretive guidelines in the CoPs to send conflicting messages to providers and surveyors, leading to harmful delays in patient and resident care. Unfortunately, some State surveyors appear to have misinterpreted the existing definitions and interpretive guidelines in the LTC CoPs and the interpretive guidelines in the Hospital CoPs to believe that the provision of any nutritional supplements (or any mechanically altered foods) at any time constitutes a therapeutic diet requiring a physician's order. As a result, facilities receive inappropriate citations for perceived deficiencies. Other surveyors have even more egregiously misinterpreted the definition of therapeutic diet by issuing citations for the provision of simple snacks without a physician's order, including milkshakes, yogurt, and peanut butter and jelly sandwiches. The chilling effect of overly aggressive surveyor interpretations negatively impact quality of patient care and health outcomes.

The LTC CoPs never require an individualized care plan (developed after extensive assessment and analysis) prior to providing nutritional supplements, even though the care plan is an essential, required step when prescribing a therapeutic diet. In the "Food Fortification and Supplementation" section of the LTC CoPs, there is no reference to resident assessments or individualized care plans. Instead, it lists nutritional supplements among various (and clearly non-therapeutic diet) interventions that enhance nutrient or caloric intake such as "[o]ffering smaller, more frequent meals; [p]roviding between-meal snacks or nourishments; or [i]ncreasing the portion sizes of a resident’s favorite foods."22 Perhaps more tellingly, whenever nutritional supplements are mentioned in connection with therapeutic diets, the LTC CoPs consistently refer to them as distinct interventions.23

This distinction comports with references in the Hospital CoPs; when providing examples of certain non-routine occurrences that hospitals must accommodate, "nutritional supplements" are not listed as a subset of "changes in diet orders." Instead, the State Operations Manual (SOM) distinguishes the two occurrences (using principles of statutory interpretation) by listing them seriatim.24 Elsewhere, the Hospital CoPs recognize that some, but not all, nutritional supplementation would be therapeutic diets, providing that "[t]he frequency of consultation depends on the total number of patients, their nutritional needs and the number of patients requiring therapeutic diets or other nutritional supplementation."25 Under this interpretation recognizing not all nutritional supplements are part of a therapeutic diet, there could be difference in the way "standard house supplements" and "disease-specific supplements" are treated.

ADDITIONAL UNNECESSARY OR BURDENSOME REGULATIONS

We are grateful for the opportunity granted in the proposed rule to comment on regulations that are unnecessary, obsolete, or excessively burdensome on health care providers. We have identified specific additional regulatory provisions related to LTC CoPs and the ability to provide patients with both Diabetes Self-Management Training and Medical Nutrition Therapy on the same day.

Additional Revisions to LTC Conditions of Participation

After consultation with member experts in the LTC field, the Academy submits the below recommended revisions to the existing CoPs for LTC Facilities. The Academy's rationale for its recommended revisions and references to relevant industry standards, associated CMS interpretive guidance and regulations, and the Academy's evidence-based position papers are included in the attached spreadsheet.

§483.1 (L) Resident Rights
Current Language: Specially prepared or alternative food requested instead of the food generally prepared by the facility as required by 483.35 of this subpart.
Academy Recommendation: Delete provision

§483.20 - - (2)i Resident Assessment
Current Language: (2) A comprehensive care plan must be — (i) Developed within 7 days after completion of the comprehensive assessment…
Academy Recommendation: Add prior to existing provision: At the time of admission, a preliminary plan of care is formulated based on the initial assessment of the resident by the interdisciplinary team. A comprehensive care plan will then be — (i) developed within 7 days after completion of the comprehensive assessment..."

Current Language: (d) A facility must maintain all resident assessments completed within the previous 15 months in the resident's active medical record.
Academy Recommendation: Change "15 months" to "6 months" in subsection (d).

§483.25 Quality of Care
Current Language: (1) A resident's ability in activities of daily living does not diminish unless circumstances of the individual's clinical condition demonstrate that diminution was unavoidable. This includes the resident's ability to — (iv) Eat; and…
Academy Recommendation: The Academy seeks interpretive guidance for this section referencing that the goal is to model a home life environment.

Current Language: (3) A resident who is unable to carry out activities of daily living receives the necessary services to maintain good nutrition, grooming, and personal and oral hygiene.
Academy Recommendation: (3) A resident who is unable to carry out activities of daily living receives the necessary services to maintain acceptable parameters of nutritional and hydration status and good grooming, personal and oral hygiene.

Current Language: (c) Pressure sores. Based on the comprehensive assessment of a resident, the facility must ensure that — (2) A resident having pressure sores receives necessary treatment and services to promote healing, prevent infection and prevent new sores from developing...
Academy Recommendation: Add: ", including adequate nutrition and hydration as determined during assessment by the qualified dietitian and other members of the inter-disciplinary team."

Current Language: (d) Urinary incontinence. Based on the resident's comprehensive assessment, the facility must ensure that — (2) A resident who is incontinent of bladder receives appropriate treatment and services to prevent urinary tract infections and to restore as much normal bladder function as possible...
Academy Recommendation: Add: ", including adequate nutrition and hydration as determined during assessment by the qualified dietitian and other members of the inter-disciplinary team."

Current Language: (g) Naso gastric tubes. 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 naso gastric tube unless the resident's clinical condition demonstrates that use of a naso gastric tube was unavoidable.
Academy Recommendation: Change references to "naso gastric tubes" to "artificial nutrition" and add subsection "Enteral nutrition should be in accordance with advanced directives."

Current Language: (2) A resident who is fed by a naso gastric or gastrostomy tube receives the appropriate treatment and services to prevent aspiration pneumonia, diarrhea, vomiting, dehydration, metabolic abnormalities, and nasal-pharyngeal ulcers and to restore, if possible, normal eating skills.
Academy Recommendation: Change references to "naso gastric tubes" to "artificial nutrition". Insert "as determined during assessment by the qualified dietitian and other members of the inter-disciplinary team" after "appropriate treatment and services".

Current Language: (i) Nutrition. Based on a resident's comprehensive assessment, the facility must ensure that a resident — (1) Maintains acceptable parameters of nutrition status such as body weight and protein levels, unless the resident' clinical condition demonstrates that this is not possible; and (2) Receives a therapeutic diet when there is a nutrition problem.
Academy Recommendation: Replace current subsection (2) to "(2) Receives a therapeutic diet as determined by the comprehensive assessment and at the recommendation of the qualified dietitian and licensed independent practitioner after consideration of oral intake goals and a preference for liberalized diets."

Current Language: (j) Hydration. The facility must provide each resident with sufficient fluid intake to maintain proper hydration and health.
Academy Recommendation: Change to "(j) Hydration. The facility must provide each resident with sufficient fluids and monitor intake to maintain proper hydration and health as recommended by the interdisciplinary team."

Current Language: (k) Special needs. The facility must ensure that residents receive proper treatment and care for the following special services:
Academy Recommendation: Change to: "The facility must ensure that residents receive proper treatment and care by qualified practitioners competent in performing the following special services:"

Current Language: (v) In the presence of adverse consequences which indicate the dose should be reduced or discontinued; or
Academy Recommendation: Change to "presence of adverse consequences, including food and drug interactions, which indicate…"

§483.35 Dietary Services

Current Language: (2) A qualified dietitian is one who is qualified based upon either registration by the Commission on Dietetic Registration of the American Dietetic Association or on the basis of education, training, or experience in identification of dietary needs, planning and implementation of dietary programs.

Academy Recommendation: "Qualified dietitian" refers to one who is qualified based upon either registration by the Commission on Dietetic Registration, the credentialing body of the Academy of Nutrition and Dietetics, or as permitted by State law, on the basis of substantially similar education, training, or experience in identification of dietary needs, planning, and implementation of dietary programs as that of registered dietitians." Use "consistent" instead of "frequently" for (1); scheduled consultation with a qualified dietitian with frequency as defined …

Current Language: (f) Frequency of meals: (1) Each resident receives and the facility provides at least three meals daily at regular times comparable to normal mealtimes in the community.
Academy Recommendation: Delete "regular." Recommend change to "provides food throughout the day to meet the individual needs of the resident with at least three meals daily at times comparable to normal mealtimes in the community."

Current Language: (2) There must be no more than 14 hours between a substantial evening meal and breakfast the following day; except as provided in (4) BELOW. Left out the issues of 16 hours or needs substantial snack.
Academy Recommendation: Change to "(2) Foods of choice are available whenever residents are hungry, not just at scheduled meal times." Include interpretive guidance that "whenever residents are hungry" should not be interpreted to mean a full course meal prepared and served that would require the kitchen to be open around the clock. Residents should be able to obtain substantial items within reason, such as sandwich, soup, ice cream, fruit, etc. that are stocked in unit or neighborhood pantries.

Current Language: (2) Resident Selection criteria. (iii) The facility must base resident selection on the charge nurse's assessment and the resident's latest assess and plan of care.
Academy Recommendation: Replace "the charge nurse's assessment" with "the interdisciplinary team's assessment."

Permit MNT and DSMT Services on the Same Day

The Social Security Act provides, in part, that the determination of the provision of Diabetes Self-Management Training (DSMT) and Medical Nutrition Therapy (MNT) services is deferred to the discretion of the Secretary. CMS indicated that MNT and DSMT cannot be provided on the same date of service.27 Senator Mark Kirk's attached letter identifies problems with the burdensome, costly regulation and its negative impact on patient care:

This current regulation burdens quality and access to care and creates undue hardships for persons with diabetes, especially those for disparate populations. Many beneficiaries forego necessary DSMT and MNT care because they cannot schedule services on the same day. A regulatory change would allow beneficiaries to consolidate often -difficult and increasingly expensive trips to ambulatory care settings to receive care.

CMS has cited the dual positive impact of both DSMT and MNT Medicare services for qualifying individuals with diabetes, and has acknowledged data indicating that, "provision of both Medicare benefits may be more medically effective for some beneficiaries than receipt of just one of the benefits." MNT and DSMT are distinct from each other, but are both necessary for improved beneficiary health outcomes. Further, same day provision allows for more effective multidisciplinary care.28

The MNT and DSMT benefits act synergistically to improve beneficiaries' quality of care, allowing for individualized and general nutrition planning and blood glucose monitoring by qualified non -physician providers such as registered dietitians. The current regulation limiting same day DSMT/MNT services creates burdensome impediments to quality patient-centered care and increases health care costs at both the individual and systems level. If the 2002 coverage determination were reformed to allow for the provision of same day service for DSMT and MNT in this circumstance, a beneficiary would be more likely to receive ample disease management and education. Associated diabetes education and disease management by non-physician providers saves money and decreases healthcare utilization.29 Compared to no prevention, self-management reduces a high -risk person's 30-year chances of getting diabetes by about 11%, the chances of a serious complication by 8% and the chances of dying of a complication of diabetes by 2.3%.30 With the flexibility of having both services available on the same day, the likelihood of beneficiaries maintaining their appointments will increase. Preventive self-management, combined with reduced 17 numbers of no-shows and lost days from work and school will result in significant cost savings to the health care system.

The Secretary retains the authority and discretion to determine the time period to render MNT and DSMT services; the Academy urges CMS to reform the existing restrictive limitation to facilitate the demonstrated benefits of same-day DSMT and MNT services.

The Academy appreciates the multiple opportunities for comment on regulations that CMS has identified as unnecessary, obsolete, or excessively burdensome on health care providers. We recognize the complexity of eliminating certain CoPs as "obsolete, unnecessary, burdensome, or counterproductive" and look forward to working with CMS to identify regulations "that can be modified to be more effective, efficient, flexible, and streamlined." As one of the first professional groups to embrace evidence-based practice, the Academy created the world's first evidence-analysis nutrition library and produces guides for condition-specific nutrition care that we hope you will look towards as you finalize the proposed rule and reform additional burdensome regulations. Please contact either Jeanne Blankenship or Pepin Tuma any questions or requests for additional information.

Sincerely, 

Jeanne Blankenship, MS RD
Vice President, Policy Initiatives and Advocacy

Pepin Andrew Tuma, Esq.
Director, Regulatory Affairs


References

Attached Supporting Documents: Virginia Dietetic Association Abstract Form "Improving Timeliness of Nutrition Intervention through Dietitian Therapeutic Diet Order Entry;" Title 42 Public Health Part 483 Requirements for States and Long Term Care Facilities; Sept 2011 letter to CMS Director Donald Berwick from Senator Mark Kirk, Illinois).

1 Medical nutrition therapy (MNT) is an evidence -based application of the Nutrition Care Process. According the Academy’s definition, the provision of MNT (to a patient/client) may include one or more of the following: nutrition assessment/ re -assessment, nutrition diagnosis, nutrition intervention and nutrition monitoring and evaluation that typically results in the prevention, delay or management of diseases and/or conditions.

2 http://www.hl7.org/documentcenter/private/standards/v3/V3_DAM_DIETORD_INFORM_R1_2013FEB.zip

3 Barker LA, Gout BS, Crowe TC. Hospital malnutrition: prevalence, identification and impact on patients and the healthcare system. Int J Environ Res Public Health. 2011; 8(2); 514–527. 4 Fessler T, "Malnutrition: a Serious Concern for Hospitalized Patients". Today’s Dietitian; July 2008. 5 Elia M. Nutrition, hospital food and in -hospital mortality. Clin Nutr. 2009;28:481–483. 6 Philipson T, et al. "Impact of Oral Nutritional Supplementation on Hospital Outcomes". Am J Manag Care. 2013;19(2): 121 -128 (Enhancing care practices with nutritional interventions yielded a 6.7% decrease probability in 30 day hospital readmissions and a 21% decrease in length of stay.). 7 Ibid. 8 Cawood AL, Elia M, Stratton RJ. Systematic review and meta -analysis of the effects of high protein oral nutritional supplements. Ageing Res Rev. 2012;11(2):278 -96.

4 Fessler T, "Malnutrition: a Serious Concern for Hospitalized Patients". Today’s Dietitian; July 2008.

5 Elia M. Nutrition, hospital food and in -hospital mortality. Clin Nutr. 2009;28:481–483.

6 Philipson T, et al. "Impact of Oral Nutritional Supplementation on Hospital Outcomes". Am J Manag Care. 2013;19(2): 121-128 (Enhancing care practices with nutritional interventions yielded a 6.7% decrease probability in 30 day hospital readmissions and a 21% decrease in length of stay.).

7 Ibid.

8 Cawood AL, Elia M, Stratton RJ. Systematic review and meta -analysis of the effects of high protein oral nutritional supplements. Ageing Res Rev. 2012;11(2):278 -96.

9 Available March 28, 2013 at http://www.cms.gov/Medicare/Provider -Enrollment -and - Certification/SurveyCertificationGenInfo/Downloads/SCletter05 -04.pdf

10 MDS 3.0 RAI Manual, Chapter 3, Section K: Swallowing/ Nutritional Status, available http://www.cms.gov/Medicare/Quality--‐Initiatives--‐Patient--‐Assessment--‐ Instruments/NursingHomeQualityInits/MDS30RAIManual.html accessed 19 March 2013.

11 Ibid., Defining "mechanically altered diet" as "[a] diet specifically prepared to alter the texture or consistency of food to facilitate oral intake. Examples include soft solids, puréed foods, ground meat, and thickened liquids. A mechanically altered diet should not automatically be considered a therapeutic diet."

12 Ibid.

13 See, e.g., Kinn TJ. Clinical order writing privileges. Support Line. 2011; 33; 4; 3–10.

14 Peterson SJ, Chen Y, Sullivan CA, et al. Assessing the influence of registered dietician order--‐writing privileges on parenteral nutrition use. J AM Diet Assoc. 2010; 110; 1702–1711.

15 Lessar S, Woodward S, Carter S. Improving Timeliness of Nutrition Intervention through Dietitian Therapeutic Diet Order Entry. Abstract attached hereto.

16 The Academy recognizes that the CoPs may require a non-physician practitioner to be licensed to be appointed to the medical staff, but no such licensure requirement exists for practitioners merely to become privileged or authorized to order patient diets without appointment to the medical staff. See, Interpretive Guidelines to §482.12(c)(1) ("Practitioners other than doctors of medicine or osteopathy may join the medical staff if the practitioners are appropriately licensed and medical staff membership is in accordance with State law."). (Emphasis added.)

17 State Operations Manual, Appendix A -- Survey Protocol, Regulations and Interpretive Guidelines for Hospitals, accessed 26 March 2013 at www.cms.gov/manuals/Downloads/som107ap_a_hospitals.pdf.

18 Ibid.

19 There are two slightly different definitions for "therapeutic diet" in the State Operations Manual for Long Term Care. Compare 42 C.F.R. §483.25(i) ("‘Therapeutic diet’ refers to a diet ordered by a health care practitioner as part of the treatment for a disease or clinical condition, to eliminate, decrease, or increase certain substances in the diet (e.g., sodium or potassium), or to provide mechanically altered food when indicated.") with the Interpretive Guidelines for §483.35(e) ("‘Therapeutic Diet’ is defined as a diet ordered by a physician as part of treatment for a disease or clinical condition, or to eliminate or decrease specific nutrients in the diet, (e.g., sodium) or to increase specific nutrients in the diet (e.g., potassium), or to provide food the resident is able to eat (e.g., a mechanically altered diet)."). In addition, CMS most recently adopted a definition and interpretive guidelines for "therapeutic diet" for the Resident Assessment Instrument (MDS 3.0) mirroring that approved by the Academy: "A diet intervention ordered by a health care practitioner as part of the treatment for a disease or clinical condition manifesting an altered nutritional status, to eliminate, decrease, or increase certain substances in the diet (e.g., sodium, potassium)."

20 42 C.F.R. §483.25(i).

21 "Nursing Homes--Medication Pass Clarification for Surveying F Tags 332 and 333 During Nursing Home Surveys," CMS Memorandum to State Survey Agency Directors, 28 September 2007, Ref: S&C--‐07--‐39. (Emphasis added.)

22 LTC SOM §483.25(i) ("With any nutrition program, improving intake via wholesome foods is generally preferable to adding nutritional supplements. However, if the resident is not able to eat recommended portions at meal times or to consume between--‐meal snacks/nourishments, or if he/she prefers the nutritional supplement, supplements may be used to try to increase calorie and nutrient intake.").

23 LTC SOM §483.25(i) (monitoring includes "reviewing the continued relevance of any current nutritional interventions (e.g., therapeutic diets, tube feeding orders or nutritional supplements).") (Emphasis added.); Id., Investigative Protocol for Nutritional Status ("While conducting the resident dining observations: Observe the serving of food as planned with attention to portion sizes, preferences, nutritional supplements, prescribed therapeutic diets and between--‐meal snacks to determine if the interventions identified in the care plan were implemented); §483.20(b)(xi) Guidelines ("Nutritional status refers to weight, height, hematologic and biochemical assessments, clinical observations of nutrition, nutritional intake, resident’s eating habits and preferences, dietary restrictions, supplements, and use of appliances.") (Indicating distinction between dietary restrictions and supplements).

24 Hospital SOP §482.28(b) ("The hospital should have written policies and procedures that address at least the following: . . . Accommodation of non--‐routine occurrences (e.g., parenteral nutrition (tube feeding), total parenteral nutrition, peripheral parenteral nutrition, change in diet orders, early/late trays, nutritional supplements, etc).").

25 Hospital SOP §482.28(a)(2) Interpretive Guidelines (Emphasis added).

26 42 U.S.C. 1395x(s)(2)(V)(i). "Medical nutrition therapy services (as defined in subsection (vv)(1)) in the case of a beneficiary with diabetes or a renal disease who - (i) has not received diabetes outpatient self -management training services within a time period determined by the Secretary . . ."

27 Centers for Medicare & Medicaid Services. NCD Decision Memo for Medical Nutrition Therapy Benefit for Diabetes & ESRD (CAG -00097N). February 28, 2002.

28 Senator Mark Kirk letter to Donald Berwick, MD MPP, dated 23 September 2011, attached hereto Quoting Centers for Medicare & Medicaid Services. NCD Decision Memo for Medical Nutrition Therapy Benefit for Diabetes & ESRD (CAG - 00097N). Centers for Medicare & Medicaid Services Website. http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?from2=viewdecisionmemo.asp&id=53&.

29 See Robbins JM, Thatcher GE, Webb DA, Valdmanis VG. Nutritionist visits, diabetes classes, and hospitalization rates and charges: the Urban Diabetes Study. Diabetes Care. 2008;31(4):655 -60; Boren SA, Fitzner KA, Panhalkar PS2; Specker, J. Costs and Benefits Associated with Diabetes Education: A Review of the Literature. The Diabetes Educator. 2009;31(1):72 -96.

30 Ibid.