Novitas Draft Wound Care LCD (ID DL35125)  

The following is provided as commentary by me personally and has not been vetted by the APWH Legislative Committee or other members of this organization and is provided as my personal opinions and observations. We encourage you to review the original Novitas Draft LCD which you can review by clicking the link below to develop your own opinions to use and with your response to this LCD. That said my comments below I hope are helpful as you go through this process. Robert Bartlett MD FAPWHc

Click here to review the original Novitas Draft LCD

It is disappointing the Novitas Draft LCD for Wound Care provides an inappropriately short window for informed commentary. The following is a summary of the problematic statements in the proposed policy. Each states is preceded by the page and line number, should the reader wish to review the entire context of the statement. Each statement is followed by commentary.

The appendix to this document contains a high-lighted version of the entire draft LCD including references. The purpose of the high-lighting is to save time for busy practitioners who wish to quickly review those sections which are worrisome.

01 | Page 3 Line 39: Medicare coverage for wound care on a continuing basis for a given wound in a given patient is contingent upon evidence documented in the patient’s record that the wound is improving in response to the wound care being provided.

COMMENT

This is a statement of abandonment whereby Medicare will not provide for wound care if the patient does not progress. In many instances, the patient maybe incapable of providing appropriate wound care.

02 | Page 4 Line 10: In rare instances, due to severe underlying debility or other factors such as operability, the goal of wound care provided in outpatient settings may be only to prevent progression of the wound.

COMMENT

This is an open-ended statement which provides no specific guidance as to what scenarios would qualify. Furthermore it does not state whether the wound care which is provided to “prevent progression” will be paid for. (It should be noted the wording awkward as it is unclear whether the care is “preventing progression” towards healing or “preventing progression” in terms of wound enlargement.)

03 | Page 4 Line 15: The appropriate interval and frequency of debridement depends on the individual clinical characteristics of patients and the extent of the wound.

COMMENT

This statement is in sharp contrast to the categorical limit of 8 debridements regardless the “clinical characteristics of patients and extent of the wound”. See observation 09 below.

04 | Page 7 Line 04 [Item #5]: Since the overall goal of care is healing and not palliation, it is neither reasonable nor medically necessary to continue a given type of wound care if evidence of wound improvement as outlined in this LCD cannot be shown.

COMMENT

This is an unqualified statement which is problematic when applied to practice. For example, if a patient with a spinal cord injury with a pressure ulcer does not improve, per the LCD, it is “neither reasonable or medically necessary to continue a given type of wound care”. Accordingly, the practitioner would suspend moist dressings, roho cushions, and low air-loss mattresses?

05 | Page 7 Line18 [Item #10]: Surgical debridement will be considered not reasonable and necessary when documentation indicates the wound is without infection, necrosis, devitalized, fibrotic, nonviable tissues or foreign matter and has pink to red granulated tissue. When utilized, it is expected that the frequency of debridement will decrease over time.

COMMENT

This statement ignores the established phenomenon of epibole (contact inhibition). It also ignores undermining which many need to be surgically corrected.

06 | Page 7 Line 41 [Item #18]: Disposable non-powered mechanical or single use non-electrically powered NPWT (CPT codes 97607, 97608) for any indication is considered not medically reasonable and necessary.

COMMENT

This statement does not comply with evidenced-based rules (no supporting references are provided). The SNAP NPWT product was demonstrated to be just as effective as an electrically powered device in a prospective randomized trial. Payment is contingent on evidence, not the method by which negative pressure is created.

07 | Page 7 Line 24 [Item #24]:

Medicare expects that with appropriate care:

◦ Wound volume or surface dimension should decrease by at least 10 percent per month or

◦ Wounds will demonstrate granulation tissue advancement of no less than 1 mm/week.

COMMENT

This statement does not comply with evidenced based rules (no supporting references are provided). Although the concept of wound healing trajectory has been popularized, it cannot be generalized to all clinical scenarios – smokers, autoimmune disease, renal failure, etc.

08 | Page 9 Line 24 [Item #7]: The patient’s expected restoration potential must be significant in relation to the extent and duration of treatment required in achieving this potential. If wound closure is not a reasonable goal, then the expectation is to optimize recovery and establish an appropriate non-skilled maintenance program.

COMMENT

This statement most likely violates the American Disability Act for patients with spinal cord injuries, motor neuron disease, demyelinating disease, visual impairment from diabetic retinopathy, severe arthritis, strokes, mild dementia, etc, etc. All of these patients would be incapable of caring for their wounds and recognizing serious events. In other words a “non-skilled maintenance program”.

09 | Page 10 Line12: Debridements will be limited to eight total services per year for any of the debridement codes listed in this LCD (CPT codes 11000,11004-11006,11010-11044, 97597 and 97598). Of the eight debridements, no more than five debridements involving removal of muscle and/or bone (CPT codes 11043, 11044) per year will be considered reasonable and necessary. Services beyond these limits may be considered through the redetermination process when supported in the medical record.

COMMENT

This statement does not comply with evidenced based rules (no supporting references are provided). In addition, this is an unclear accounting method. As stated, the LCD allows for only 8 debridements annually. As such it ignores the possibility of developing a second wound from minor trauma, infection, or a vascular event. Additionally it does not allow for the possibility of a relapse of the original wound within a year

10 | Page 10 Line 17: No more than 6 NPWT (CPT codes 97605-97606) services in a four month period will be considered reasonable and necessary. NPWT services exceeding this frequency may be covered upon redetermination only when medical necessity continues to be met as previously outlined and there is documented evidence of clear benefit from the NPWT treatment already provided.

COMMENT

This statement does not comply with evidenced based rules (no supporting references are provided).

11 | Page 10 References:

  • No debridement references.
  • No supporting evidence for a limit of eight debridements annually.
  • No references supporting healing rates in general or by wound type

However of the 28 references provided, 18 references (66%) are for maggot debridement therapy (MDT). Sad, but true.

COMMENT

The draft LCD does not show any due diligence or systematic approach to providing evidenced-base recommendations. The absence of scientific principles places the Medicare population at significant risk for harm – including death. All wounds are at risk for infection. To underscore the serious nature of infection, more than 11,000 people die annually in the United States from methicillin resistant Staph Aureus which is almost twice the annual death rate for HIV infection.

APPENDIX: Novitas Draft LCD for Wound Care (High Lighted with annotations).

Draft URL: https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=37162&ContrId=331&ver=7&ContrVer=1&CntrctrSelected=331*1&Cntrctr=331&DocType=Proposed_NRTF&kq=391011145&ua=highwire&displayPDFNote=Y&bc=AgACAAQAAAAAAA%3d%3d&