Response to Comments: Enteral Nutrition – DL38955

Several commenters offered their support for the proposed Enteral Nutrition LCD with limited suggestions for improvement.

The DME MAC Medical Directors would like to thank the individuals and/or associations for taking the time to submit detailed comments and offering support for the vast majority of the language in the proposed Enteral Nutrition LCD.

Many commenters requested a revision to the documentation requirements for special enteral formulas that requires the prescriber to document formulas tried and unfavorable events associated with standard formula prior to ordering specialty formula. The commenters provided examples of diagnoses such as allergies, phenylketonuria (PKU), renal disease, etc. where a standard enteral formula trial may be contraindicated. Additionally, commenters indicated the proposed policy would not allow for clinical judgement to prescribe specialty formulas where a trial on standard formula may be detrimental to the beneficiary’s health.

The DME MACs agree with this comment. The special enteral formula documentation requirements in the policy article will be updated to read:

Special nutrient formulas, HCPCS codes B4149, B4153, B4154, B4155, B4157, B4161, and B4162, are produced to meet unique nutrient needs for specific disease conditions. If a special nutrient formula is ordered, the beneficiary’s medical records must specify why a standard formula cannot be used to meet the beneficiary’s metabolic needs. This documentation may include other formulas tried and failed or considered and ruled out. A diagnosis alone is not sufficient to support the medical need for a specialty formula.

One commenter indicated the documentation requirements for special enteral formulas are not appropriately placed in the Enteral Nutrition Policy Article since the requirements are not consistent with the coverage criteria or supported by the summary of evidence in the proposed LCD.

Thank you for your comment. The DME MACs respectfully disagree with the concerns regarding the location of the special enteral formula documentation requirements. The proposed LCD outlines the requirement for the medical need for special enteral formulas to be justified for each beneficiary. The policy article provides additional details on what type of documentation is deemed acceptable to meet that criteria. Refer to the response to comment #2 for additional details related to changes made to the special enteral formula documentation requirements.

Many commenters requested the removal or modification of the specialty formula documentation requirement which indicates a diagnosis alone is not sufficient to document the need for a specialty formula.

Refer to the response to comment #2 for details related to updates made to the special enteral formula documentation requirements.

One commenter suggested that dysphagia be listed as a typical example of a condition that would qualify a patient for enteral nutrition.

The list of typical examples is not intended to be all-inclusive. If the symptom of dysphagia is caused by a full or partial non-function or disease of the structures that normally permit food to reach the small bowel, and it is expected to last a long and indefinite duration, the beneficiary would qualify for enteral nutrition.

One commenter requested coverage of enteral nutrition for beneficiaries with Alzheimer’s or other types of dementia since these patients may be unable to swallow due to their neurological disorder.

Beneficiaries with Alzheimer’s or other types of dementia are not excluded from coverage. In order to qualify for enteral nutrition under the prosthetic benefit, they must have a full or partial non-function or disease of the structures that normally permit food to reach the small bowel or a disease that impairs digestion and/or absorption and it is expected to last a long and indefinite duration.

One commenter requested coverage of enteral nutrition for beneficiaries with cancer whose metabolic processes are not functioning properly and require supplemental nutrition.

The LCD provides coverage for beneficiaries with a full or partial non-function or disease of the structures that normally permit food to reach the small bowel or a disease that impairs digestion and/or absorption. A beneficiary with a cancer diagnosis may qualify for coverage if one of the above conditions are met and it is expected to last a long and indefinite duration.

One commenter requested one month be considered a long and indefinite duration to allow coverage of enteral nutrition for beneficiaries that do not need to remain inpatient but have a need for enteral nutrition.

Medicare is a program with defined benefits and enteral nutrition is covered under the prosthetic device category. Prosthetic devices are defined in the CMS Benefit Policy Manual (Pub 100-02), Chapter 15 (in relevant part) as items “which replace all or part of an internal body organ (including contiguous tissue), or replace all or part of the function of a permanently [emphasis added] inoperative or malfunctioning internal body organ.” Enteral nutrition that is not required for a long and indefinite duration would not meet the benefit category requirements.

One commenter noted their agreement with the National Institute for Health and Clinical Excellence (NICE) recommendations of determining malnutrition and indicated those guidelines support the allowance for enteral nutrition for patients with a functional gastrointestinal (GI) tract who are unable to maintain health and weight based on an oral diet.

Medicare is a program with defined benefits and enteral nutrition is covered under the prosthetic device category. Beneficiaries with a functioning GI tract would not meet the prosthetic device benefit as defined in the response to comment #8.

One commenter requested the verbiage “treating practitioner” be changed to “multidisciplinary or interdisciplinary team” to allow documentation from other clinicians. For example, this would allow a registered dietician to document the test of permanence has been met or document a failed trial of a standard formula.

Medicare Program Integrity Manual (CMS Pub 100-08) Chapter 5 Section 5.11 Evidence of Medical Necessity states in relevant part and with emphasis added:

“If necessary or appropriate for a medical necessity determination, the DME MAC, UPIC, or other contractor must ask the supplier to obtain documentation from the treating practitioner, establishing the severity of the patient's condition and the immediate and long term need for the equipment and the therapeutic benefits the patient is expected to realize from its use. A claim of therapeutic effectiveness or benefit based on speculation or theory alone cannot be accepted. When restoration of function is cited as a reason for use of DMEPOS, the exact nature of the deformity or medical problem should be clear from the medical evidence submitted. Also, the manner in which the equipment or device will restore or improve the bodily function should be explained by the treating practitioner.”

Therefore, documentation in the medical record related to meeting the test of permanence must be completed by the treating practitioner.

However, the example provided in the proposed LCD Policy Article attachment related to documentation requirements for special enteral formula was not intended to be prescriptive. An update to the example language in the LCD-Related Policy Article will be made to provide clarity and will now read:

For example, an order for a diabetes-specific formula may be supported by documentation in the medical record that the beneficiary has a diagnosis of diabetes mellitus and has experienced severe fluctuations of glucose levels on standard formula.

One commenter requested the LCD/PA include detailed information regarding documentation requirements for the following coverage criterion: “Adequate nutrition must not be possible by dietary adjustment and/or oral supplements.”

Documentation in the medical records must support that enteral nutrition is necessary in order to maintain weight and strength commensurate with the beneficiary's overall health status. Additionally, the medical record should include details on any previous dietary adjustments and/or oral supplementation tried and failed or considered and ruled out.

One commenter included a specific example of a denied claim for enteral nutrition where they felt clinical judgement should have been used to allow payment. The commenter requested clarification on what level of clinical judgement or inference is allowed by medical review.

Individual claims adjudication questions and medical review procedures are outside the scope of the current proposed LCD.

One commenter requested clarification on what percentage of calories must come from enteral nutrition versus oral nutrition in order to qualify under the benefit and whether there is a requirement for a statement in the medical record that identifies how much oral intake is consumed.

The Enteral Nutrition LCD does not include any specific caloric requirements for enteral nutrition versus oral nutrition. The documentation must support that enteral nutrition is necessary in order to maintain weight and strength commensurate with the beneficiary's overall health status.

One commenter requested the inclusion of a list of covered diagnosis codes for enteral nutrition. The commenter indicated they understood a full list may not be feasible, but a partial list of common qualifying diagnoses would assist as a point of reference for suppliers and practitioners.

The Enteral Nutrition LCD is not a diagnosis-driven LCD (with the exception of ReliZorb); therefore, no specific list of covered ICD-10s for enteral nutrition is included. As noted by the commenter, the list of potentially covered diagnoses would be too extensive to include. Additionally, the severity of conditions varies from patient to patient where enteral nutrition may not be appropriate for the entire population of individuals with a specific diagnosis.

One commenter indicated that the LCD no longer provides a definition of “a long and indefinite duration” which was previously defined as a condition that would last “ordinarily at least 3 months”. The commenter would like clear definition of what constitutes a long and indefinite duration included in the LCD and clarification if coverage for conditions lasting less than 3 months may be allowed.

Enteral nutrition is provided under the prosthetic device benefit, which requires that a beneficiary must have a permanently inoperative internal body organ or function thereof [emphasis added]; however, this does not require that the impairment will persist throughout the beneficiary’s remaining years. If the medical records, including the judgment of the treating practitioner, indicates that the impairment will be of long and indefinite duration, the test of permanence is considered met.

One commenter requested the policy include a statement to clarify the test of permanence starts from the time when a beneficiary was initiated on enteral nutrition in a hospital or other setting.

Determination of permanence is not based upon when enteral nutrition was initiated for a beneficiary. To satisfy the test of permanence, there must be documentation to reflect that in the treating practitioner’s judgement, the impairment will be of long and indefinite duration.

One commenter requested clarification on the coverage of nasogastric or nasojejunal tubes.

The proposed Enteral Nutrition LCD is not prescriptive as to which type of feeding tube is utilized by the beneficiary in order to qualify for coverage.