Response to Comments: Wound Care (DL37228)

WPS received numerous concerns, from a templated letter, strongly recommending that WPS eliminate the arbitrary limit of the number of debridements per patient per year and allow for clinically appropriate services tailored to the patient’s needs.

Thank you for your comments.  We have updated the LCD.

WPS received numerous templated comments recommending the elimination of the arbitrary limit of the number of Negative Pressure Wound Therapy (NPWT) services within a year’s time. There also was one comment suggesting we follow clinician and manufacturer’s guidelines to establish correct utilization parameters for NPWT.

One Provider noted that patients utilizing NPWT need their dressing changed three times a week and it is not appropriate to delegate this to the patients and caregivers. Another Provider commented that many patients while they may not qualify for home health assistance are limited to what they can do physically to assist in their own dressing changes, for example obesity (unable to reach ulcer site) or failing eye sight (unable to see).  

Another inquiry noted NPWT should be applied by a professional and by limiting NPWT services that would not allow for adequate evaluation of these wounds by a qualified professional.   

One Provider personally states he/she has seen the impact NPWT has on patient outcomes. 

NPWT dressings need to be changed every 48-72 hours and a patient could have this therapy for 6 weeks if the wound is deep and is responding well to the therapy. The provider continued by saying the patient may also have more than one wound that needs this therapy in the 4 month period.  

A NPWT vendor provided the following information:

Recommendation from vendor: For CPT codes 97605 and 97606 is a maximum of four months; 30-day progress notes are required. Because tNPWT dressings must be applied by a wound care professional, 97606 should be limited to a maximum of 15 applications per wound per month.

We would agree with the parameters that were provided and have updated the LCD and accompanying Article.

Coverage of traditional NPWT (tNPWT) device/unit/type, or supplies is under DME and providers should consult their DME LCD for specific coverage, parameters, and guidelines.

A couple of Providers commented the verbiage pertaining to NPWT is confusing and vague and they did not know if it pertained to disposable or traditional DME wound vacs.

Thank you for your Comment.  Clarification has been added to the LCD that the coverage for traditional NWPT (tNWPT) device/unit/type, or supplies is under DME and providers should consult their DME LCD for specific coverage, parameters, and guidelines. Clarification has been added to the LCD discussing coverage guidelines for dNPWT. Billing and Coding guidelines for dNWPT have been added to A55909 Wound Care Coding Companion for Wound Care L37228.

There were numerous templated comments disagreeing with the specific quantifiable rate of wound closure per week (should decrease by at least 10 percent per month or wounds will demonstrate margin advancement of no less than 1 mm/week).  Commenters noted that there was no scientific evidence that is accepted uniformly to what the adequate rate should be, and healing is not a linear process.  The rate of closure varies significantly by patient and is influenced by a number of factors including but not limited to the type and size of wound, comorbidities, and compliance with prescribed therapy.  

Another commenter noted case studies on wound care and felt that this should be in line with all the indicators of wound healing used in wound care studies (such as healing percentage at 4 and 12 weeks etc) 

One organization commented: “Remove these statements. What is documented in the literature is that reduction of less than 40% for venous and less than 50% for diabetic ulcers at 4 weeks is an overall predictor of outcome for healing.” 

A Provider commented: “Wounds often require serial debridement of exposed muscle and/or bone for the following reasons: Tissue necrosis in the setting of arterial insufficiency, pressure injury, or infection may evolve over time due to 1) ongoing insult, for example sustained excess pressure while awaiting delivery of a proper off-loading surface, or 2) delayed manifestations of a prior insult that has been addressed and remedied. Therefore, ischemically compromised tissue may initially appear viable.” 

Another comment regarding healing rate of wounds: “Debridement of bone may intentionally be performed in stages, especially in the case of diabetic foot ulcers with infected bone involvement, were the least amount of bone removal is attempted to preserve joint or limb salvage. Therefore, it is medically reasonable that serial bone debridements may be the most appropriate limb saving technique of debridement for the patient.

We agree that wounds do heal at different speeds and the LCD has been updated.  We also agree that there may be medical necessity for debridement of bone in stages.

“The requirement to quantify the progression of healing on a weekly basis – as set forth in the Draft LCD – is inconsistent with other Medicare policies such as the National Coverage Determination (“NCD”) for Hyperbaric Oxygen Therapy (“HBO”). The HBO NCD states: “Wounds must be evaluated at least every 30 days during administration of HBO therapy. Continued treatment with HBO therapy is not covered if measurable signs of healing have not been demonstrated within any 30-day period of treatment.” The NCD requires confirmation of measured improvement, but coverage is not contingent on a specific minimum threshold quantitative metric against which progress is measured.”

The NCD for HBO speaks only about HBO therapy and monitoring.  It does not dictate the follow up time for debridement or other wound care not address by that NCD.

WPS received numerous templated comments recommending coverage of “CPT 97602 which is mechanical debridement as a non-selective debridement.”

Another inquiry, stated by eliminating mechanical debridements as a covered service contradicts

with what is included in CPT. By definition, mechanical debridements are classified as a non-selective

debridement. Non-selective debridements are a covered service under CPT code 97602, which states “Mechanical Debridement: West-to-dry or dry-to-dry dressings may be used with wounds that have a high percentage of necrotic tissue. Wet-to-dry should be used cautiously as maceration of surrounding tissue may hinder healing.” The Provider concluded there are instances when non-selective debridement is needed.

Another organization had this comment regarding Mechanical Debridement: “Mechanical debridement is a debridement service and should qualify as such. Other AB MACs have included mechanical debridement services in their LCD policies, as it is a valuable and effective service. To say that mechanical debridement does not qualify as a debridement service is simply inaccurate and not clinically sound policy. Furthermore, it contradicts what is included within the CPT code. By definition, mechanical debridement’s are classified as a non-selective debridement. Non-selective debridement are a covered service under CPT code 97602 which states: Mechanical Debridement: Wet-to-dry or dry-to-dry dressings may be used with wounds that have a high percentage of necrotic tissue. Wet-to-dry dressings should be used cautiously as maceration of surrounding tissue may hinder healing.”

While mechanical debridement is a valuable technique for healing ulcers, it does not qualify as a surgical wound debridement service, and therefore CPT 97597 or 97598 should not be used.

The prior statement in the LCD is correct with - Removal of necrotic tissue by cleansing, scraping (other than by a scalpel or a curette), chemical application, or dry-to-dry or wet-to dry dressing.  These dressings are not generally skilled and are different and distinct form the wet-to-moist dressings that are part of CPT code 97602.

CPT code 97602 by description is for non-selective debridement with this type of debridement as the removal of necrotic tissue by the application of a wet–to-dry or dry-to-dry dressing technique. Wet-to-dry dressings should be used judiciously as maceration of surrounding tissue may hinder healing. Generally, dressing changes are not considered a skilled service.

Clarification has been made in the LCD for the type of dressing.

Received numerous templated comments recommending WPS change the wording to consistently recommend photographic documentation.

One inquiry agreed photographic evidence is a good clinical practice but, felt before and after debridement is excessive.

One Provider commented, photography is a good idea but to mandate it assumes that everybody has an EMR to document it easily which is not the case yet.

Photographic documentation of wounds immediately before and after debridement is recommended for prolonged or repetitive debridement services (especially those that exceed five debridements per wound). Photographic documentation is required for payment of more than five extensive debridements (beyond skin and subcutaneous tissue) per wound. From January 2, 2012 article from Wound Ostomy and Continence Nurses Society: Photography in Wound Documentation: Fact Sheet: Photography is a commonly used means of communication among health care providers to monitor wound healing (or failure to heal). The WOCN Society neither mandates nor discourages photography but seeks to encourage the development of standard policies and guidelines to assist the practitioner when photography is used and describe how protected health information (PHI) is secured.
http://c.ymcdn.com/sites/www.wocn.org/resource/resmgr/Publications/Photography_in_Wound_Documen.pdf

The use of photography is part of the documentation for wound care and WPS-GHA will maintain the verbiage as in the Draft.

Photographic documentation of wounds immediately before and after debridement is recommended for prolonged or repetitive debridement services (especially those that exceed five debridements per wound).

WPS received numerous templated emails limiting the available tools to care for a wound, can be dangerous to the patient and raise the cost of care.

Appropriate tools for debridement have been included in the Draft LCD.  Not all new items are proven to be medically necessary or are Investigational and Experimental.

Received numerous templated comments stating the Draft Wound Care policy would require “nearly 25 pages of documentation for every hour of patient care.” 

Good medical record documentation is key to document the facts of the patients care and supplements the provider’s memory of critical details.  Detailed records can guide the provider in developing treatment plans, improves patients’ clinical outcomes, assists other providers who also care for the patient and has a part in quality assurance practices.

There were several comments addressing the multiple comorbidities comprising the healing potential and the draft policy will further debilitate the patient’s overall health. 

Another comment, addressed the many influencing factors involved and these factors make it impossible to use a "cookie cutter" approach.  I believe that these policies will limit our ability to effectively treat patients.  Patients will be the ultimate ones to suffer from these policies.

Another provider commented healing is an event taking into account multiple variables that affect the healing process.

WPS-GHA does agree that healing times may vary, and that the multiple variables need to be taken into consideration for treatment. However, there should be some improvement seen for the treatment to be considered medically necessary.

Provider agreed with Wound Care Policy.

Thank you for your comments.

Received a few comments voicing concern with the published bibliography policy not substantiating the utilization parameters that are identified in this draft policy and that WPS created arbitrary parameters without clinical or scientific basis.  There was a comment about the importance to review the most recent information including product’s studies, clinical practice guidelines, science, research, or other clinical evidence to support utilization parameters being established. 

Another comment addressed the lack of current medical literature in the draft policy supporting the number of debridements performed in a given period

Please see the updated bibliography to support the final LCD.

There were a few questions why Stage 2 ulcers were omitted from the Draft LCD?

Stage 2 pressure ulcer should be included in the Draft Policy. Stage 2 pressure ulcer is defined by the National Pressure Ulcer Advisory Panel as “Partial thickness skin loss with exposed dermis”. Stage 2 pressure ulcers are by definition an “ulcer” therefore should be included in Draft LCD.

In late 2015, WPS made changes to its active Wound Care LCD and excluded debridement of Stage 2 pressure ulcers. After evaluation, WPS rescinded and changed its position by allowing debridement of Stage 1 and 2 pressure ulcers effective 02/01/2016. Provider requests CMS reference for not allowing coverage for Stage 1 and Stage 2 pressure ulcers.

In 2015, with an update to the prior Wound Care LCD for NCD ICD 10 codes the Stage 1 and Stage 2 codes were removed inadvertently from the full LCD.  Since this would have been restrictive that is the reason why the Stage I and II codes were returned to the prior LCD since the LCD did not go to a CAC at that time.  WPS’ position did not change on allowing debridement of Stage I and II pressure ulcers, and now with the new draft LCD being taken back to through the CAC process these codes could be removed. Please see the definition of Stage II wound below.

Definition of Stage II by National Pressure Ulcer Advisory Panel (NPUA)

“Partial-thickness loss of skin with exposed dermis. The wound bed is viable, pink or red, moist, and may also present as an intact or ruptured serum-filled blister. Adipose (fat) is not visible and deeper tissues are not visible. Granulation tissue, slough and eschar are not present. These injuries commonly result from adverse microclimate and shear in the skin over the pelvis and shear in the heel.”

http://www.npuap.org/resources/educational-and-clinical-resources/npuap-pressure-injury-stages/

There were two comments regarding this statement referring to surgical debridement: “This is usually carried out in the operating theatre under anesthesia by a surgeon” is ambiguous and unclear.”  Another Provider commented of the necessity for use of general anesthesia for sharp debridement vs local.

The statement was changed to read: “This is usually carried out in the operating room by a surgeon.  Anesthesia is usually required.”

A provider who removes difficult skin cancers with Mohs surgery was asking to add codes S01.00XA or S01.00XD. If using T81.89XA that is currently in the draft the Provider requested T81.89X be added for subsequent visits.

Thank you for your comment.  We have added that code T81. 89XD. The S01.00 range (laceration without foreign body of scalp) would not be appropriate to add at this point since a laceration itself is not a non-healing wound.

Another commenter noted that the listing of conditions that would require debridement lacks the most prevalent diagnosis/conditions: diabetic foot ulcers (DFU). The comment continued to point out not all diabetic ulcers are neuropathic ulcers and since (E11.621 and E11.622) are listed as a diagnosis these ulcers should be applicable for debridement services.

There were a few comments that the draft LCD covers many wound types but, it does not cover all. Some examples given were area wounds due to vasculitis, vasculopathy, medications such as hydroxyurea, fungal infections, scleroderma, sickle cell anemia, and radiation necrosis.

The draft does list the wound type categories of neuropathy or ischaemia. We agree that not all diabetic foot ulcers are neuropathic ulcers and therefore Neuroischaemia has been added to the LCD.  Neuroischaemia is the term for the combined effect of diabetic neuropathy and ischaemia. We believe the LCD list covers the type of wounds for debridement.

Electric Stimulation: A Provider recommended against denoting specific wound types for coverage.

Please refer to CMS Publication 100-03, Medicare National Coverage Determination Manual, Chapter 1- Part 4, § 270.1 Electrical Stimulation (ES) and Electromagnetic Therapy for the Treatment of Wounds determines the wound types for coverage, and not this LCD.

Regarding the requirement for physical therapist’s documentation is onerous, unnecessary, and do not offer Medicare beneficiaries any additional protection. The Provider voiced that the documentation requirements were unfair to Physical Therapist and asked why other health care professional treating wounds were not included.

All providers are required to document the care provided.  Physical Therapists by regulation do have the additional requirements below.  Please do note that all other providers have the other requirements, but do not get the option of “weekly progress notes”.  All other providers must have progress notes for each visit. 

• Physician order(s) for physical therapy (PT)/wound care services.
• Certification/recertification for PT/wound care services.
• Actual minutes provided to support each timed service/HCPCS provided.

There was a provider who practices at a wound clinic in a hospital setting concerned the draft policy limitations would affect how the clinic would treat patients. The Provider is trained to perform weekly debridement’s on wounds which could be either selective or surgical based on the level of debridement needed.

Frequency of debridement should be driven by medical necessity.

One inquiry agreed with eliminating mechanical debridement as a covered service.

Thank you for your comments.

An association made several comments regarding the draft policy.  “The definition of debridement should be defined as the removal of foreign material and/or devitalized or contaminated tissue from or adjacent to an ulcer or wound until surrounding”.

As stated in the LCD: “Debridement is defined as the removal of foreign material and/or devitalized or contaminated tissue from or adjacent to a traumatic or infected wound until surrounding healthy tissue is exposed.”

Provider requests the terms “non-viable” be added with “necrotic” tissue and that “dead” tissue be replaced with “non-viable and necrotic”.

Non-viable and dead are changed to “necrotic” in the LCD.

WPS should specify all appropriate instruments that can be used for selective debridement. The only instruments that can be used when removing necrotic tissue are either a scalpel or a curette when tissue nippers or an ultrasonic debrider etc should be listed.

Selective debridement as listed in the LCD includes selective removal of necrotic tissue by sharp dissection including scissors, scalpel, and forceps; and selective removal of necrotic tissue by high-pressure water jet.  This is the list as per the AMA CPT code description.

Provider requested clarification to the term “usually” is defined by WPS to mean “always” as WPS does not allow 11043 and 11044 to be performed in a non-facility setting.

CPT codes 11043, 11046 and 11044, 11047 may only be billed in place of service inpatient hospital, outpatient hospital or ambulatory surgical center (ASC).  The CPT codes 11043,11046 and 11044, 11047 are codes that describe deep debridement of the muscle and/or bone. The verbiage used is “may only be billed in”.

Provider wants clarification of the inconsistency of allowing and paying for amputation of a toe (28820) In an office setting, yet not allow removal of a bone from a toe?

This comment is not related the Draft LCD

Requests that all applicable locations (ASC, hospital, office etc) be allowed for sharp debridement.

CPT code 11042 for debridement of the subcutaneous tissue is allowable in the office setting.  Please see Response 24 for the deeper debridement of muscle and/or bone.

Why the need for the LCD to discuss the use of anesthesia for debridement procedures? “They continued to say the use of anesthesia often times is not required and may be part of the global surgical service associated with debridement”

Thank you for your comment.  Other providers do want or need this clarification.

Requests the removal of the verbiage, “clinician’s responsibility” from this paragraph in the Draft LCD. 

Enzymatic Debridement is debridement with topical enzymes used when the necrotic substances to be removed from a wound are protein, fiber and collagen. The manufacturers’ product insert contains indications, contraindications, precautions, dosage and administration guidelines. It would be the clinician’s responsibility to comply with those guidelines.

The sentence, “It would be the clinician’s responsibility to comply with those guidelines” has been removed from the LCD.

Define or remove “measurable” in the sentence.” Evidence of improvement includes measurable changes(decreases) of some of the following:”

Clarification was added to LCD.

Please clarify, “removal of fibrinous material from the margin of an ulcer”.

From the margin of an ulcer, one would remove fibrinous material.

Opposes the statement, “Paring or cutting of corns or non-plantar calluses. Skin breakdown under a dorsal corn that begins to heal when the corn is removed, and shoe pressure eliminated is not considered an ulcer and does not require debridement unless there is extension into the subcutaneous tissue.” Feels WPS is redefining the term “ulcer”. Wound authorities consider breakdown of skin as a standard definition of an ulcer.

Any wound must fit the definition of an ulcer Stage III or IV.  We have clarified the verbiage in the LCD.  Please note the verbiage of “that begins to heal”, and “does not require debridement unless there is extension into the subcutaneous tissue.”

Disagreed with the following statements: “Infrared, ultra-sound thermal and phototherapy- ultraviolet modalities are not considered reasonable or necessary debridement services”.

This is a CMS NCD’s verbiage. Please see CMS IOM Publication 100.03 Medicare National Coverage Determinations (NCD) Manual Chapter 1, Section 270.6 Infrared Therapy Devices

Comment made that with the documentation requirements specified in this draft LCD since it will take the provider longer to complete the documentation the provider feels that “the CPT definition of the -25 modifier is therefore applicable to the appropriate E/M service as defined by CPT.

The -25 modifier is defined by the 2017 AMA CPT Guidance as, “Significant, Separately Identifiable Evaluation and Management Service by the Same Physician or Other Qualified Health Care Professional on the Same Day of the Procedure or Other Service.”

The -25 modifier would not be appropriate in this case, since there is no “significant, separately identifiable” E&M.

The process of developing a draft LCD should be transparent and information forthcoming to any stakeholder interested in the policy. This allows for meaningful comments on the policy being drafted. The information that a MAC utilizes in creating or revising an LCD should all be contained in the Sources of Information and Basis for Decision bibliography in order for stakeholders to review that information to better understand how the MAC substantiated the language placed in the LCD created or revised. The information should be transparent and accessible.

Please refer the LCD’s bibliography.

One organization felt the conditions (ICD-10 codes) within the policy were limited. Some the conditions that were recommended to add but, limited to include: Stage 1 or 2 Pressure Ulcers, Necrotizing Fasciitis, Osteomyelitis, Pyoderma Grangrenosum,

Please review Article for ICD-10 codes.  Stage I or II Pressure ulcer are purposely not included. The other three examples were in the ICD-10 code list already.

Felt the LCD ‘s definition of wound care is limited and should include: all open ulcers, dehisced surgical sites, post amputation sites, post-surgical sites, pin sites, pressure ulcers, venous and mixed-arterial ulcers and diabetic foot ulcers as well.

Pin sites are not addressed by this LCD unless they become chronic non-healing wounds following pin removal.

There is no evidence in current Guidelines or the literature to substantiate limiting MIST therapy to 18 services in a six-week period. Recommend WPS remove this limitation, as it is not medically supported.

We have not received any literature that would support expanding MIST frequency.