Response To Comments Article

Response to Comments: Parenteral Nutrition - DL38953

A58837

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Article ID
A58837

Article Title
Response to Comments: Parenteral Nutrition - DL38953

Article Type
Response to Comments

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07/22/2021

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Article Guidance

Article Text

During the 45-day comment period, which was open February 25, 2021 through April 10, 2021, the DME MACs received comments from 9 commenters.

NOTE: DME MACs review all submitted comments and may choose to consolidate similar thematic comments or redact or withhold certain submissions (or portions thereof such as those containing private or proprietary information or inappropriate language or duplicate/near duplicate submissions). As a result, there may be a discrepancy between the number of comments in the article and the actual number of comments received.

Introduction to Responses

The DME MACs appreciate the comments received from stakeholders during the open comment period on the proposed Parenteral Nutrition Local Coverage Determination (LCD) (DL38953). We reviewed the comments in their entirety. Submitted comments that cite published, peer-reviewed literature provide suitable evidence that may inform policy, while less rigorous comments (e.g., anecdotal, unpublished information not subject to peer review) are much less influential to policy determinations.

Pursuant to the CMS Program Integrity Manual (CMS Pub. 100-08) Chapter 13:

In conducting a review, MACs shall use the available evidence of general acceptance by the medical community, such as published original research in peer-reviewed medical journals, systematic reviews and meta-analyses, evidence-based consensus statements and clinical guidelines.

Accordingly, the final policy and our response to comments are based on the best currently available published clinical evidence, to support optimal health outcomes in Medicare beneficiaries.

Response To Comments

Number	Comment	Response
1	Multiple commenters requested that the rate of reimbursement for an intravenous lipid emulsion be reinstated as previous to July 1, 2020.	Thank you for the comment; however, it is outside the scope of the current proposed LCD.
2	Several commenters requested that the medical necessity for lipid use be defined using weight-based recommendations outlined by American Society of Parenteral and Enteral Nutrition (ASPEN). Peer-reviewed published studies were referenced to support this recommendation. One commenter provided a hypothetical example whereby following ASPEN guidelines, the patient would require 1800 gram (gm) lipid use monthly, exceeding the amount allotted in the proposed LCD. Another commenter proposed to change lipid use description to a weight-based dosage formula of a maximum of 2 gm/kg/day before additional medical necessity documentation would be required.	Following a review of the evidence submitted and relevant package inserts, we agree that the evidence-based dosing of lipid emulsions is weight-based. Since this dosing is typically product-specific per FDA approval, we will modify the language to specify that additional medical necessity documentation will be required for dosing outside of the product-specific FDA approved dosing for beneficiaries.
3	Several commenters strongly recommended the removal of all home mix codes from the Parenteral Nutrition proposed LCD and policy article attachment. These commenters cited that home mix of parenteral nutrition (PN) is obsolete, non-compliant, and unsafe. The commenters submitted Medicare utilization data in support of their position.	Thank you for your comment. The requirement for home mix preference is stipulated in the Enteral and Parenteral Nutrition Therapy NCD (180.2). The process for requesting a change to NCD 180.2 may be found on the CMS Coverage web site.
4	Several commenters recommended changing “ordering practitioner” to “medical or multidisciplinary/interdisciplinary team” and one commenter recommended changing the phrase to “medical record must,” in effort to reflect that patients are often managed by teams of clinicians and that the practitioner who ordered TPN is often not the practitioner who manages the TPN in the outpatient setting. Clarification is requested regarding upon whom it is incumbent to document medical necessity for PN when multiple specialties and/or settings may be involved in the beneficiary’s care.	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.
5	One commenter proposed to change the protein range to 0.8 – 2.0 gm/kg bodyweight/day, in an attempt to allow for updated practices that meet the protein needs of the stable patient with exudate presumably coming from an abdominal wound or gastrointestinal tract. Peer-reviewed published guidelines were referenced to support this recommendation.	We agree. Based on the best available guidelines for macronutrient dosing in stable adults, 0.8 – 2.0 gm/kg/day is recommended. The range will be corrected to reflect this evidence.
6	One commenter recommended deleting the dextrose concentration language of needing documentation if dextrose concentration is less than 10%. The commenter noted that if the beneficiary’s calorie range is between 25-35 calories/kg body weight/day (e.g., beneficiaries requiring higher volume of fluid) then the dextrose concentration is irrelevant.	Thank you for the comment; however, we respectfully disagree. Based on the best available evidence, and ‘strong recommendation’ by the ASPEN for total nutrient, admixtures of ≥10% monohydrated dextrose, along with ≥4% amino acids, and ≥2% injectable lipid emulsion provide the most physical stability for admixtures. This language will remain unchanged.
7	Several commenters stated that the timing of the practitioner’s evaluation should not be tied to the DME Information Form (DIF), but rather to the clinical assessment that led to the recommendation to initiate PN.	We agree. The language has been changed to reflect more emphasis on a patient-oriented approach such that timing is tied to the assessment that led to the decision to initiate PN as opposed to completion of the DIF.
8	Several commenters suggested that B4186 HCPCS code referencing lipids was in error.	We agree and have corrected the code in the final LCD.
9	One commenter requested clarification regarding how much and what specific documentation is required when ordering PN.	Policy specific documentation requirements are found in the LCD-related Policy Article. The documentation must reflect that the beneficiary has: (a) a condition involving the small intestine and/or its exocrine glands which significantly impairs the absorption of nutrients; or, (b) disease of the stomach and/or intestine which is a motility disorder and impairs the ability of nutrients to be transported through and absorbed by the gastrointestinal (GI) system. The documentation must also reflect that the treating practitioner has concluded that the beneficiary’s condition is of a long and indefinite duration.
10	One commenter requested clarification regarding the documentation requirements that would reflect enteral nutrition as “impractical” and parenteral nutrition as reasonable and necessary.	We have clarified this language to reflect the clinical circumstances that make administration of enteral nutrition difficult or impossible to provide.
11	Two commenters requested that a shorter time frame (e.g., one month) be used to define “permanence” for conditions that would require parenteral nutrition. They suggested parenteral nutrition should be covered under the proposed LCD for beneficiaries with “acute” conditions because they could receive care in the home setting rather than in the hospital, skilled nursing facility, or long-term acute care hospital setting. They felt the use of parenteral nutrition was warranted even if the anticipated clinical outcomes resolved the need for parenteral nutrition in a timeframe less than three months.	Thank you for the comment; however, we respectfully disagree. The Benefit Policy Manual Chapter 15 section 120 requires conclusion by the treating practitioner that the beneficiary’s condition is of a long and indefinite duration.
12	Two commenters suggested that the hospitalization requirement for training on TPN administration was an undue burden to the patient and that home initiation should be covered. Two peer-reviewed published studies were referenced to support this recommendation. Another asked for this requirement to be clarified.	Thank you for your comment; however, the requirement for hospitalization upon initiation of PN is stipulated in the NCD. The process for requesting a change to NCD 180.2 may be found on the CMS Coverage web site.
13	One commenter suggested that professional services in association with PN should be covered as they are for the external infusions pump therapies.	We appreciate the comment; however, it is outside the scope of the current proposed LCD.
14	One commenter suggested coverage of PN for patients with cancer and those recovering from major surgery.	A beneficiary with a cancer diagnosis or who has undergone major surgery may qualify for coverage of PN if the documentation meets the requirements stated in the LCD and the condition is expected to last a long and indefinite duration.
15	Several commenters suggested that the proposed LCD align with the former LCD in regard to daily caloric intake requirements of combined sources of nutrition, as it is medically necessary for patients to wean from PN when transitioning to an enteral or oral diet.	We agree. The language has been changed to reflect the total caloric intake requirements, rather than those required for PN only.
16	One commenter suggested that documentation requirements were burdensome for physicians.	We believe that in the proposed LCD we have emphasized an evidenced-based, patient-oriented approach, and focused the documentation requirements to those that support medical necessity for PN.
17	Two commenters requested the Policy Article for parenteral nutrition supply and administration kits be clarified to indicate the request for refill requirements are not applicable.	Thank you for the comment; however, it is outside the scope of the current proposed LCD.
18	One commenter wanted to confirm that coverage for PN is available for beneficiaries that do not meet criteria (a) a condition involving the small intestine and/or its exocrine glands which significantly impairs the absorption of nutrients or (b) disease of the stomach and/or intestine which is a motility disorder and impairs the ability of nutrients to be transported through and absorbed by the GI system but have a disease state that impacts one of those conditions.	The documentation must reflect that the beneficiary has (a) a condition involving the small intestine and/or its exocrine glands which significantly impairs the absorption of nutrients or (b) disease of the stomach and/or intestine which is a motility disorder and impairs the ability of nutrients to be transported through and absorbed by the GI system.
19	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 a clear definition of what constitutes a long and indefinite duration, included in the LCD.	The CMS Benefit Policy Manual outlines the requirements for the prosthetic benefit. “Long and indefinite” is stated in the benefit’s definition.

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Associated Documents

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LCDs
L38953 - Parenteral Nutrition

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07/15/2021	07/22/2021 - N/A	Currently in Effect	You are here

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Response to Comments: Parenteral Nutrition - DL38953

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