Table of Contents
1. Advantages
2. Compliance
3. Umbrella Requirements
4. Medical Necessity
5. Primary and Secondary Surgical Dressings
6. “Exudate” Versus “Drainage”
7. Product Requirements
8. More Documentation Requirements
9. Updated Information
10. Choosing the Proper Dressing Size
11. Proof of Delivery
12. Standard Written Order
13. Conclusion

Practitioners who participate in the surgical dressing program can dispense high quality wound care products directly to their patients. Examples of surgical dressings include collagen, calcium alginate, foam, gauze, hydrocolloids, hydrogel, and compression garments.

Advantages

Dispensing the products a patient needs to care for their wounds directly to the patient eliminates the need for the patient to deal with a pharmacy to get these products. This is an advantage to participation in the surgical dressing program because, often, the travel to the pharmacy is a barrier to the patient getting the wound care products they need. Eliminating the pharmacy also eliminates the possibility of the item the practitioner ordered being substituted or changed to something less efficacious by the pharmacy.

Patients may also experience surprise copays at a pharmacy that can be a barrier to receiving the products they need. Finally, sometimes a pharmacy may be able to provide part, but not all, of what was ordered and ask the patient to return another day to pick up the rest of the order. This is also a barrier to a patient receiving what they need to care for their wounds.
Patient convenience is a tremendous advantage to participating in the surgical dressing program. Patients enjoy being handed the products they need to care for their wounds at the provider’s office or having them delivered directly to their home the day after a provider encounter. Peer – reviewed literature demonstrates improved patient compliance when products are delivered in these manners as opposed to requiring travel to a pharmacy.
Practitioners who dispense surgical dressings typically purchase the dressings and keep them in their office. They then dispense the dressings to patients for whom they are medically necessary and enjoy profits for their business because the reimbursement associated with the dressings is often significantly higher than the costs. Both patients and practitioners enjoy tremendous advantages through their participation in the surgical dressing program.

Compliance

Just like every other service practitioners provide for the beneficiaries of third party payers, there are compliance guidelines to consider when participating in the surgical dressing program. Fortunately, the guidelines for the service of dispensing surgical dressings are very clearly outlined. While Medicare is a national program, it is administered on a local level by Medicare Administrative Contractors (MACs).

There are MACs for Part B services and MACs for durable medical equipment (DME). As surgical dressings are a form of DME, the compliance guidelines for surgical dressings dispensed to Medicare beneficiaries are provided by the DME MACs, CGS Administrators, LLC and Noridian Healthcare Solutions, LLC. Non-Medicare third party payers may have their own coverage policies, but most non-Medicare third party payers that provide this benefit use the same guidelines that are provided by the DME MACs. This article shares the guidelines of the DME MACs.

Both DME MACs list the same guidelines that govern coverage of surgical dressings for Medicare beneficiaries in their “Surgical Dressings” Local Coverage Determination (L33831) and “Surgical Dressings” Policy Article (A54563). Because there are only two DME MACs in the US and their surgical dressing policies are identical, the compliance guidelines are the same for all Medicare providers in the country.

Umbrella Requirements:

Surgical dressings are covered for Medicare beneficiaries if:

  • The dressing(s) are medically necessary
  • The exudate quantity of the wound(s) to be treated is documented
  • Debridement of the wound to be treated was medically necessary and it was debrided, or the surgical dressings are to be used in the treatment of an ulcer caused by or treated by a surgical procedure

Medical Necessity

The presence and documentation of medical necessity is a requirement that applies to all medical services and supplies when submitting for payment to a third party payer. This applies to all evaluation and management services, all procedures, and all supplies, including surgical dressings. When dispensing surgical dressings, the documentation must clearly illustrate the medical necessity of the dressings. There are many situations in which surgical dressings are medically necessary. Just some include a wound in a compromised patient, a wound complicated by arterial disease, and a wound complicated by malnutrition. There are many others.

When dispensing surgical dressings, it is suggested that providers make the medical necessity of the surgical dressings very clear and not rely on an auditor’s ability to determine medical necessity based on their reading of the past medical history and the history of present illness alone. Providers may even consider documenting a sentence that starts with, “This surgical dressing is medically necessary because………” Including a sentence like this removes the risk associated with an auditor or other third party payer representative attempting to find or interpret medical necessity based on other contents of the documentation.

An example of a portion of a progress note that clearly demonstrates the medical necessity of collagen powder is:

“

 This is a chronic ulcer. This ulcer is not demonstrating signs that lead me to believe it will heal if current treatment continues and advanced healing options are not instituted. Ulcers of this nature have a high rate of failure to heal, and high rates of infection, amputation, other morbidity, and even mortality associated with them. Therefore, advanced treatment in the form of collagen powder is medically necessary and indicated in an effort to heal this chronic ulcer and prevent amputation. Collagen was selected as this wound is stalled and not progressing toward the goal of healing the way it should be. I expect the collagen to attract monocytes and fibroblasts, act as a sacrificial substrate for MMPs, and ultimately provide a matrix for tissue and vessel growth.
The information in the rest of the note should support this statement of medical necessity. The DME MAC policies do not list any requirements regarding the number of weeks a wound must be present for coverage of surgical dressings. They also do not list a certain number of weeks that must have passed during which a wound failed to respond to other treatment options.

Primary and Secondary Surgical Dressings

There is no cure for lymphedema.  However, it can be managed when the appropriate tools are employed.  When lymphedema is appropriately managed, the risks of the complications listed above occurring are significantly decreased.

A tenant of any lymphedema treatment plan is compression.  Historically, compression has been a challenge and this is largely a result of antiquated, inconvenient compression garments.  These traditional garments are often difficult or impossible for patients to apply, difficult for patients to take off, and uncomfortable.  Additionally, some patients complain of older compression garments being too hot.  For all of these reasons and others, patients’ ability or willingness to use these older compression garment options has traditionally been less than what is needed for treatment success.

Extermit-EASE changes all of that with a revolutionary design that makes it much easier for patients to apply, remove, and tolerate.  Extremit-EASE combines a zipper and bungees with large tabs to make independent application and adjustment easy for patients to achieve—even if they suffer from dexterity issues.  Patients appreciate the lightweight, air permeable fabric allowing for hours of comfortable wear with less sweat, fewer hot spots, and less pistoning.

An air permeability study demonstrated that Extremit-EASE provides between 3 and 11 times the amount of air permeability than more traditional options.  This supports the fact that the lightweight, air permeable fabric of Extremit-EASE contributes to fewer problems with experiencing heat and other discomfort when using Extremit-EASE.

Another study[1] demonstrated the marked difference in compliance with compression when the Extermit-EASE is used.  This study truly tested the improvement when Extremit-EASE is selected over other options by only including patients with venous insufficiency or lymphedema who had failed treatment with standard compression because they could not tolerate it.  On a scale of 1-5, with 1 being “very difficult” and 5 being “very easy,” patients in the study ranked “ease of application” with the more traditional compression garment as 1.74 versus 4 with Extremit-EASE.  On a scale of 1-5, with 1 being “very uncomfortable” and 5 being “very comfortable,” patients in the study ranked “comfort” with the more traditional compression garment as 1.91 versus 4.17 with Extremit-EASE.  The patients in this study were able to wear the Extremit-EASE almost twice as many hours per day as they did the more traditional option.  Better compliance by patients with the treatment they need results in better results for them and better outcomes for medical practices[2].

When dispensing surgical dressings, the DME MAC Policy Article2 states that the documentation must include whether the dressing is being used as a primary dressing or secondary dressing.  This should never be left subject to interpretation or assumption by a chart reviewer but instead should be clearly documented.  It is suggested that the note contain a sentence that states, “This product will be used as a ___________ (fill in primary or secondary) dressing.”

If dispensing multiple products at the same time, as in the case of an AmerX® Wound Care Kit, each product should be accounted for and this designation of primary versus secondary use should be made for each product.  This could be accomplished with a sentence such as, “The collagen powder in this kit will be used as a primary dressing and the bordered gauze in this kit will be used as a secondary dressing.”

For assistance in determining the primary or secondary designation of AmerX dressings, this summary may be helpful:

HELIX-3 Collagen – Primary
AmerX Foam Dressing – Primary or secondary
AmerX Calcium Alginate Dressing – Primary or secondary
AmerX Gauze Dressing – Secondary
Amerigel® Hydrogel Wound Dressing – Primary
AmerX Hydrocolloid Dressing – Primary or secondary
EXTREMIT-EASE® Compression Garment- Secondary

 

“Exudate” Versus “Drainage”

The DME MAC policies state documenting the quantity of exudate is a requirement for reimbursement of surgical dressings. The word “drainage” does not appear in the DME MAC Surgical Dressings policies. Instead, the word “exudate” is used when describing the coverage requirements for each dressing type. As it applies to surgical dressings, when documenting the amount of fluid that is seeping out of a wound, it is recommended that practitioners use the word “exudate” instead of “drainage.” The reason is auditors are often not clinicians. An auditor evaluating a progress note and looking for the documentation that reflects the amount of “exudate” from a wound may not be capable of equating that to the amount of “drainage” documented.

The coverage for many surgical dressings is, in part, dependent on the volume of exudate. Some coverage requirements include:

Foam:  Moderate to heavy exudate

Calcium Alginate:  Light to Moderate exudate

Hydrogel:  Minimal or no exudate

Collagen:  Light to moderate exudate, or wounds that have stalled or have not progressed toward a healing goal.

Keeping in mind the above messaging regarding auditors not always being clinicians, it is recommended that practitioners supplying surgical dressings use the exact words listed above to document exudate. For example, when dispensing hydrogel, and documenting exudate, use the words “minimal exudate” or “no exudate” when documenting the exudate quantity. Doing so eliminates the need for any interpretation by an auditor and decreases the chance of an auditor making an error.

Product Requirements

In addition to the umbrella requirements listed above, each product type has its own documentation requirements for coverage:

Collagen: Must document medical necessity and one or more of:

The wound is full thickness
The wound has light to moderate exudate
The wound has stalled or has not progressed toward a healing goal

Foam: Must document medical necessity, the wound has moderate to heavy exudate, and the wound is full thickness.

Calcium Alginate: Must document medical necessity, the wound has moderate to heavy exudate, and the wound is full thickness.

Hydrogrel: Must document medical necessity, the wound has zero to light exudate, and the wound is full thickness.

Hydrocolloid: Must document medical necessity and the wound has light to moderate exudate.

More Documentation Requirements

The documentation created when surgical dressings are dispensed should also include:

  • Ulcer location
  • Ulcer type
  • Ulcer Stage
  • Ulcer length, width, and depth
  • Type of surgical dressing(s) dispensed
  • Dressing size(s)
  • Number of dressings dispensed
  • Number of wounds being treated
  • Frequency of surgical dressing changes
  • Anticipated duration of surgical dressing requirement

If a kit is dispensed with multiple surgical dressing types, then these documentation requirements must be met for each dressing included in the kit.

All these items listed above must be documented in the progress note even if they are also documented in the Proof of Delivery and / or Standard Written Order.

 

Updated Information

The DME MAC Surgical Dressings policies require that the clinical information that demonstrates the medical necessity of dispensed surgical dressings be updated on a monthly basis if the patient is using the product(s) for more than one month. If the patient who has received surgical dressings is in a nursing facility or if the patient has a heavily draining or infected wound, this update must be performed weekly. In this situation, the update may be performed by the prescribing / dispensing physician, a nurse, or any health care professional that is involved in the regular care of the patient.

This monthly (or weekly) required evaluation should include:

  • Wound type(s)
  • Wound(s) location
  • Wound(s) size
  • Wound(s) drainage
  • Any other relevant wound status information
The supplier does not necessarily have to be the one to perform this update. Compliance can be met if someone other than the supplier performs the evaluation and the supplier obtains the information, retains that information in the patient’s record, and documents the source and the date obtained.

Choosing the Proper Dressing Size

When dispensing surgical dressings, the dressing size should be selected based on the size of the ulcer being treated. From a clinical standpoint, the dressing should cover the entire ulcer. Practitioners should choose the smallest size of the needed dressing that will still cover the entire ulcer.

 

Proof of Delivery

As surgical dressings are a form of DME, a Proof of Delivery form must be completed when surgical dressings are dispensed. This proof of delivery may be needed to substantiate reimbursement. It may be requested by DME MACs, recovery auditors, supplemental medical review contractors, or Comprehensive Error Rate Testing (CERT) medical review contractors. This Proof of Delivery must be maintained by the supplier for seven years from the date of service. The Proof of Delivery must include:

  • Patient name
  • Address where item was delivered (i.e. practice address)
  • Description of the item
  • Quantity delivered
  • Patient or designee signature
  • Date delivered

The description of the item can be a narrative description of the item, the item’s HCPCS code, the item’s HCPCS code descriptor, and/or the item’s brand name / model number.

When surgical dressings are delivered directly, the patient or a designee who is accepting the item on behalf of the patient must sign the proof of delivery. A designee can be someone with any relationship to the patient such as a neighbor or friend. The designee may not be the supplier themselves, an employee of the supplier, or anyone that has a financial interest in the delivery of the item. When a designee accepts the item on behalf of the patient, the relationship of the designee to the patient must be noted on the delivery slip. Furthermore, if the designee signs for the item, and their signature is not legible, their name should be printed below it.

Standard Written Order

When surgical dressings are supplied, the supplier must maintain a Standard Written Order (SWO) for the dressings supplied. This requirement used to be for a “Detailed Written Order,” but that changed to a SWO as of January 1, 2020. The required elements of the SWO include:

  • Beneficiary’s name or Medicare Beneficiary Identifier (MBI)
  • Order date
  • General description of the item – The description can be either a general description (e.g., wheelchair or hospital bed), a HCPCS code, a HCPCS code narrative, or a brand name/model number
  • Quantity to be dispensed
  • Treating practitioner name or National Provider Identifier (NPI)
  • Treating practitioner’s signature

In the case that the prescribing practitioner is also the supplier, a separate SWO is not required if all the required elements of the SWO are documented in the medical record.

Conclusion

When surgical dressings are delivered directly, the patient or a designee who is accepting the item on behalf of the patient must sign the proof of delivery. A designee can be someone with any relationship to the patient such as a neighbor or friend. The designee may not be the supplier themselves, an employee of the supplier, or anyone that has a financial interest in the delivery of the item. When a designee accepts the item on behalf of the patient, the relationship of the designee to the patient must be noted on the delivery slip. Furthermore, if the designee signs for the item, and their signature is not legible, their name should be printed below it.

[1] https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=33831&ContrID=140[2] https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=54563[3] https://med.noridianmedicare.com/web/jddme/topics/documentation/standard-written-order

Dr. Jeffrey D. Lehrman, DPM, FASPS, MAPWCA, CPC
Dr. Jeffrey D. Lehrman, DPM, FASPS, MAPWCA, CPC, CPMA
Read more from Dr. Lehrman

Dr. Lehrman is a podiatrist practicing in Fort Collins, CO and operates Lehrman Consulting, LLC which provides consultation services regarding coding, compliance and documentation. Dr. Lehrman is a Certified Professional Coder and Certified Professional Medical Auditor. He serves as a staff liaison at the AMA CPT® Editorial Panel meetings where CPT codes are created, edited, and deleted. He is a Diplomate of the American Board of Foot and Ankle Surgery, Fellow of the American Society of Podiatric Surgeons, and is recognized as a “Master” by the American Professional Wound Care Association. Dr Lehrman is a Fellow of the American Academy of Podiatric Practice Management, Past Director of the American Professional Wound Care Association Board of Directors, and is a Past Chairman of the Board of the American Society of Podiatric Surgeons. Dr. Lehrman is also on the editorial advisory board of the journal WOUNDS.