LCD Reference Article Response To Comments Article

Response to Comments: Wound and Ulcer Care

A58904

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Source Article ID
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Article ID
A58904
Original ICD-9 Article ID
Not Applicable
Article Title
Response to Comments: Wound and Ulcer Care
Article Type
Response to Comments
Original Effective Date
11/28/2021
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The comment period for the Wound Care Proposed Local Coverage Determination (LCD) DL38904 began on 01/28/2021 and was presented at the 02/24/2021 Open Public Meeting. The Comment period ended on 03/15/2021 and all comments were reviewed and incorporated into the final LCD where applicable, which lead to renaming the Final LCD to Wound and Ulcer Care. The notice period begins on 10/14/2021 and ends 11/27/2021. The LCD becomes final on 11/28/2021.

Response To Comments

Number Comment Response
1

In addition to a robust discussion at the Open Meeting, records of which are maintained with this policy, Noridian received 15 written Comments. Only one of these was an individual representation, with thirteen Comments representing professional societies and associations, and one from a military facility. Due deference was accorded to all of these comments and they will be grouped, as appropriate, into categories. Noridian appreciates the contributions all CAC participants, Open Meeting presenters and attendees, and Commenters.

The broadest category of Comments involved clarity of language. Commenters noted imprecision of language, older terminology such “sharp or excisional” vs. “selective or surgical,” inclusion of “pressure ulcer/injury, and additional revisions such as:

  1. The broader definition of wound as a “disruption of normal anatomic structure and function” was further delineated into acute events “wounds” as “a break in or damage to the skin and underlying tissue as a result of an injury (or surgical intervention), where an ulcer is “deemed to be chronic due to an underlying metabolic condition” precluding the normal healing process.
  2. Categorization of acute wounds as superficial, open, traumatic wounds, crush injuries, complications of grafts and surgical wounds.
  3. Categorization of chronic ulcers as pressure ulcers, non-pressure ulcers, ulcerations with varicosities, atherosclerotic disease with ulceration, diabetic ulcers, and ulcers secondary to osteomyelitis.
  4. Elimination of reference to skin ulcers, skin ulceration, etc. since it is a reference limited to only the superficial layer of skin.
  5. Use of anatomic terms (dermis, epidermis) in the description of debridement and grafts, rather than “split-thickness,” etc.
  6. Eliminating redundant terms such as “surgical excisional biopsies”.
  7. Updating definitions of services, such as advanced dressings.
  8. Clarifying the difference between non-contact ultrasound and its uses, and contact ultrasound as a debridement tool.

Noridian appreciates the seven Commenters contributions and have implemented them with an intent to update the policy.

2

The next broad area of Commentary involved fluorescent imaging of bacterial overgrowth.

Under provisions of the 21st Century Cures Act, new technology represented by designated T codes have been afforded coverage and payment by a number of MACs, including Noridian. Noridian will observe the use and clinical impact of these technologies, as they progress toward Category I code designation.

If increasing evidentiary support is demonstrated, the covered status will be maintained, and in the absence of such support, future policy initiatives may limit or preclude coverage. The concepts of biofilm and the impact of planktonic bacterial growth, and the general term bioburden are also the subjects of evolving work, but do not warrant policy address for similar reasons as above.

3

Four Comments were received regarding the expectation of vascular assessment within two weeks of the initial patient encounter.

A comment from the Society for Vascular Surgery best summarized these opinions regarding the practicality of this standard and its potential to exacerbate health care inequities and access issues.

While Noridian remains consistent in its standard of vascular assessment, an expectation of 30 days may be a more reasonable goal and the policy is amended.

4

Five Comments were received regarding the use of Contact Ultrasound, particularly as a type of debridement.

As debridement services have historically been represented by a group of codes reflecting the extent and depth of tissues addressed, alternative technologies should use this existing group of codes to correctly represent the service performed. Further coding designations by the AMA will be addressed if, and when, they evolve.

This service is noted to be distinct from non-contact, low frequency ultrasound which is represented by CPT code 97610.

5

Noridian appreciates the endorsement of its emphasis on nutritional support by multiple commenters.

Two commenters presented contrasting views on access, while consistent in their support of this concept. One Comment was cognizant that in some rural and underserved areas, formal dietary consultation may be difficult to access, and may, consequently, delay the onset of care. A contrasting view was educating in terms of the benefits that Registered Dieticians and other nutritional support teams can add to multi-disciplinary wound care. Additionally, this Comment included a clarifying statement regarding the ASPEN criteria and the Clinical Practice Guidelines for Prevention and Treatment of Pressure Ulcers, which are primarily assessment tools for the acute care settings. Newer multi-parameter assessment tools, such as the MEAL scale, are under evaluation in the outpatient, ambulatory setting.

Noridian remains committed to this component of patient assessment, expecting that labs and a basic assessment of nutritional status be maintained in the patient’s plan of care.

6

Telehealth in Wound and Ulcer Care.

One thoughtful Comment suggested that telehealth may be a resource in terms of the clinical assessment of the wound/ulcer care patient (for example, the nutritional assessment noted in Comment #4 above). Noridian agrees but does not purport to fully understand or anticipate the coding conventions of the post-pandemic landscape.

A comment was included in the policy, generally endorsing this concept, but understanding that fundamental physical assessment is still a basic requirement.

7

Three Comments addressed the changing E&M code criteria per the AMA and the interface with procedural services.

Noridian adheres to the AMA definitions and recommends a thorough understanding of the applicable codes per AMA educational material, with specific attention to the Separately Identifiable Services Modifier.

8

Inadvertent Inclusion of a Burn Code:

One Comment from the perspective of a coding background noted the inadvertent inclusion of a burn code.

The burn code T31.33 has been removed from the article. The care of the burn patient adds additional complexity and is considered beyond the scope of this policy.

In response to this Commenter as well, the policy attempts to be more contemporary in its use of the terms acute wound, and chronic ulcer, and to include acute wounds where co-morbidities are contributing to impairment of the normal healing process.

Noridian also reminds the reader that this policy, unlike its predecessors, is developed consistent with the precepts of the 21st Century Cures Act. Not all covered services are expressly noted in the policy, services beneficial to patient care are encouraged, and services that are limited or non-covered are noted. We appreciate all of the individual efforts in the development of these comments, and the contributions at our CAC and Open Meeting.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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