Debridement Products

MISONIX, INC.

Address:
1938 New Highway
Farmingdale, NY 11735
Phone: (631) 694-9555
Website: www.misonix.com
Contact:
Michele Kennedy, Product Director
(631) 927-9184
MKENNEDY@MISONIX.COM

Description of Debridement Product including clinical trials, indications and contraindications.
Green Rounded Probe – Product # E-ASO-F2
Gold Flat Probe – Product # E-ASO-F1
Blue Cylindrical Probe – Product # E-ASO-RI
Cooper – Angled Probe – Product # E-ASO – R2
Magenta – Hatched Probe – Product # E-ASO-X1

Local Coverage Determination (LCD)
a) Do the providers use their Medicare contractor’s LCD as a guidance document for writing orders, utilization, and documentation of your debridement product?
b) What recommendations would you like to give the providers regarding the debridement LCDs?
N/A

Physician’s Order
a) What problems do you face pertaining to physician’s orders for debridement with your product?
b) What “ordering” recommendations do you have for providers who use your product?
N/A

Documentation for the Product/Procedure
a) What are the major documentation deficiencies that you encounter when providers use your product?
b) What documentation suggestions would you like to give providers who use your debridement?
N/A

Indications Covered
a) Do you encounter any issues surrounding the indications that support medical necessity for debridement with your product?
b) Do you have any medical necessity suggestions to assist providers who use your product for debridement?
N/A

Medicare Audits –
Has Medicare conducted any provider reimbursement audits pertaining to debridement?
If yes, what were the issues audited?
c) If yes, what were the audit findings and recommendations?
N/A

Reimbursement Issues and Advice
a) Does your specific debridement product have any unique Medicare reimbursement issues?
b) What reimbursement advice would you like to offer to providers who utilize your debridement product for their patients?
N/A

HCPCS Code for Product
a) If the debridement product has a CMS verified HCPCS code, please provide it and any directions that are relevant for the providers to remember when using the HCPCS code –
MISONIX, INC. does not have a specific HCPS code for the use of the SONICONE.

Medicare Payment for the Product
a) What is the 2011Medicare payment rate for your debridement product?
There is no payment for the product
N/A

CPT® Code for Procedure
a) If the debridement procedure has an AMA verified CPT® code, please provide it and any directions that are relevant for the providers to remember when using the CPT® code
The codes that are used for debridement with the use of the SONICONE are the same as the codes that one would use when doing debridement with a scalpel or curtette. There are no codes specific to the use of the SONICONE. There are a large number of codes and this is based upon what the clinician has performed. The codes that can be chosen are the following:

CPT Code Description of Procedure
Surgical Debridement
11000 Debridement of extensive eczematous or infected skin; up to 10% of body surface
11001 Debridement of extensive eczematous or infected skin; each additional 10% of the body surface (List separately in addition to code for primary procedure)
11040 Debridement; skin, partial thickness
11041 Debridement; skin, full thickness
11042 Debridement; skin and subcutaneous tissue
11043 Debridement; skin, subcutaneous tissue and muscle
11044 Debridement; skin, subcutaneous tissue, muscle and bone
Active Wound Care Management
97597 Removal of devitalized tissue from wound(s), selective debridement, without anesthesia (eg, high pressure waterjet with/without suction, sharp selective debridement with scissors, scalpel, and forceps), with or without topical application(s), wound assessment, and instruction(s) for ongoing care, may include use of a whirlpool, per session. This is specific for wounds that are ≤20 cm2
97598 Removal of devitalized tissue from wound(s), selective debridement, without anesthesia (eg, high pressure waterjet with/without suction, sharp selective debridement with scissors, scalpel, and forceps), with or without topical application(s), wound assessment, and instruction(s) for ongoing care, may include use of a whirlpool, per session. This is specific for wounds that are ≥20 cm2

Medicare Payment for the Procedure
a) What are the 2011 national average Medicare payment rates to the wound clinic and to the physicians for the debridement product/procedure?
N/A

Ultrasonic Debridement (Please answer only if you make an Ultrasonic Debridement product.)
What is the frequency that your modality utilizes?
Contact Ultrasound frequency at 22,500 Htz

What is the intensity produced?
N/A

Are you experimenting with a coupling agent besides saline and if so what?
There are many solutions that are available for use in the wound care market. Many clinicians have, on their own, used solutions that may be different than saline. Misonix currently does not recommend or specify any solution other than saline for use in the SonicOne

What is the actual debridement tool (sound head, curette type, etc?) and why is this shape effective?
Misonix currently provides six interchangeable wound debridement probes. The different shapes and sizes of these probes allow clinicians to choose the probe that is most appropriate based upon the type of wound that they are dealing with. See chart included below.

Contraindications for use?
N/A

Cost?
All system configurations are put together based upon the needs of the facility (throughput, number of patients, types of wounds, etc). The average system cost is about $45,000 - $50,000, depending upon the system configuration.

Cleaning/sterilizing?
All items can be steam sterilized (handpiece, probes, required wrenches and front housing) between uses. The generator and footswitch can easily be wiped down between uses.

PuriCore, Inc.

Address:
508 Lapp Rd.
Malvern, PA 19355
Phone:
(484) 321-2700
Website:
www.puricore.com
Products:
VASHE WOUND THERAPY
Contact:
Dave Zansitis, Senior Market & Business Development Manager
(484) 321-2755
DZANSITIS@PURICORE.COM

Description of Debridement Product including clinical trials, indications and contraindications.
Vashe Wound Therapy is cleared to debride, lubricate, and moisten:
Pressure ulcers
Post-surgical wounds
Stasis ulcers
First- and second-degree burns
Diabetic ulcers
Minor abrasions of the skin
Complementary Wound Management Procedures:
Irrigation and soaking of wound dressings
Sharp debridement
Compression therapy treatment modalities

Randomized Clinical Trial:
Vashe Wound Therapy versus Sulfamylon in the management of grafted burns: results of a pilot study.
The clinical trial was conducted by Kevin Foster, MD, MBA, FACS, Co-Director of the Arizona Burn Center at the Maricopa Medical Center in Phoenix, Arizona. Results showed that Vashe Wound Therapy is as effective as the control, 5% Sulfamylon® solution (mafenide acetate, USP), a synthetic antimicrobial agent, in the post-operative care of grafts for burns and potentially provides greater pain control. The average graft take for Vashe Wound Therapy and 5% Sulfamylon was 97.4% and 96%, respectively. Infection rates during the trial were equivalent, and none were attributable to the therapy. Further, the trial showed that Vashe Wound Therapy demonstrated greater than a 50% cost savings compared with 5% Sulfamylon.

Local Coverage Determination (LCD)
a) Do the providers use their Medicare contractor’s LCD as a guidance document for writing orders, utilization, and documentation of your debridement product?
Yes
b) What recommendations would you like to give the providers regarding the debridement LCDs?
N/A

Physician’s Order
a) What problems do you face pertaining to physician’s orders for debridement with your product?
For the best results, physicians should allow for adequate time for the Vashe Wound Therapy solution to soak in the area to be debrided. Clinicians should also use the solution liberally to adequately saturate and soak the area to be treated.
b) What “ordering” recommendations do you have for providers who use your product?
Soak the wound with Vashe Wound Therapy for 5-10 minutes prior to the debridement procedure. Use Vashe to irrigate the wound during the procedure and when appropriate saturate the dressing of choice with Vashe as part of the final dressing procedure.

Documentation for the Product/Procedure
a) What are the major documentation deficiencies that you encounter when providers use your product?
None
b) What documentation suggestions would you like to give providers who use your debridement?
Document the quantity of solution used during the procedure.

Indications Covered
a) Do you encounter any issues surrounding the indications that support medical necessity for debridement with your product?
No
b) Do you have any medical necessity suggestions to assist providers who use your product for debridement?
Vashe will support the overall process of treating/debriding wounds to reduce the active bioburden in the wound and peri-wound area.

Medicare Audits
Has Medicare conducted any provider reimbursement audits pertaining to debridement?
No

Reimbursement Issues and Advice
a) Does your specific debridement product have any unique Medicare reimbursement issues?
N/A
b) What reimbursement advice would you like to offer to providers who utilize your debridement product for their patients?
N/A

HCPCS Code for Product
a) If the debridement product has a CMS verified HCPCS code, please provide it and any directions that are relevant for the providers to remember when using the HCPCS code.
A6260

Medicare Payment for the Product
a) What is the 2011Medicare payment rate for your debridement product?
N/A

CPT® Code for Procedure
N/A
a) If the debridement procedure has an AMA verified CPT® code, please provide it and any directions that are relevant for the providers to remember when using the CPT® code.
N/A

Medicare Payment for the Procedure
a) What are the 2011 national average Medicare payment rates to the wound clinic and to the physicians for the debridement product/procedure?
N/A

Monarch Labs

Address:
17875 Sky Park Circle
Suite K
Irvine, CA 92614
Phone: (949) 679-3000
Website: www.monarchlabs.com
Contact:
Ronald Sherman, MD; Co-Founder & Laboratory Director
(949) 679-3000
RSherman@monarchlabs.com

Description of Debridement Product including clinical trials, indications and contraindications.
Medical Maggots are live fly larvae, applied to chronic wounds, to effect rapid debridement by a combination of chemical (enzymatic liquefaction) and mechanical mechanisms. Medical Maggots were granted marketing clearance by FDA in 2004, for the following indications: “. . . debriding non-healing necrotic skin and soft-tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and non-healing traumatic or post surgical wounds.” Although maggot therapy has been used successfully during the past 90 years for treating other types of problematic wounds, these were the wound types for which modern-day controlled clinical trials now exist, demonstrating efficacy and safety. Pivotal clinical publications include:

Sherman RA, Wyle F, Vulpe M: Maggot therapy for treating pressure ulcers in spinal cord injury patients. J Spinal Cord Med. 1995 Apr;18(2):71-4.PMID: 7640976

Sherman RA, Tran JM, Sullivan R: Maggot therapy for venous stasis ulcers. Arch Dermatol. 1996 Mar;132(3):254-6. PMID: 8607628

Sherman RA: A new dressing design for use with maggot therapy. Plast Reconstr Surg. 1997 Aug;100(2):451-6.PMID: 9252615

Sherman RA: Maggot versus conservative debridement therapy for the treatment of pressure ulcers. Wound Repair Regen. 2002 Jul-Aug;10(4):208-14.PMID: 12191002

Sherman RA: Maggot therapy for treating diabetic foot ulcers unresponsive to conventional therapy. Diabetes Care. 2003 Feb;26(2):446-51.PMID: 12547878

Sherman RA, Shimoda KJ: Presurgical maggot debridement of soft tissue wounds is associated with decreased rates of postoperative infection. Clin Infect Dis. 2004 Oct 1;39(7):1067-70. Epub 2004 Sep 1.PMID: 15472863

Armstrong DG, Salas P, Short B, Martin BR, Kimbriel HR, Nixon BP, Boulton AJ: Maggot therapy in "lower-extremity hospice" wound care: fewer amputations and more antibiotic-free days. J Am Podiatr Med Assoc. 2005 May-Jun;95(3):254-7.PMID: 15901812

Dumville JC, Worthy G, Bland JM, Cullum N, Dowson C, Iglesias C, Mitchell JL, Nelson EA, Soares MO, Torgerson DJ; VenUS II team. Larval therapy for leg ulcers (VenUS II): randomised controlled trial. BMJ. 2009 Mar 19;338:b773. doi: 10.1136/bmj.b773.PMID: 19304577

Warnings and contraindications include:
For a detailed list of contraindications, see the package insert (posted at www.MonarchLabs.com). The most common adverse events or problems are:

a) Do not multi-dose. Multi-dosing has been associated with product contamination.
b) Late delivery of rush orders (1-2% of shipments, average delay: 18 hours).
c) Pain occurring after 24 hours of treatment, in patients with pre-existing wound pain (reported in 5-30% of series). Pain abates as soon as the maggots are removed.
d) Sometimes, Pseudomonas aeruginosa can be a problem. This is believed to be due to a killing of other microbes more readily than Pseudomonas, leaving the Pseudomonas without microbial competitors. If maggot therapy is indicated for a wound with Pseudomonas, the Pseudomonas should be controlled or eliminated with simple topical anti-Pseudomonal treatments prior to maggot debridement therapy (MDT). The wound may also require antimicrobial treatment during MDT.

Local Coverage Determination (LCD)
According to AMA’s “CPT Advisor,” September 2008:
* Procedure (CPT) Code: 97602 ("Non-excisional debridement") (The service is often provided [bundled] with some other billable office code)
* Supply code: CPT® supply code 99070 ("Supplies and materials provided by the physician over and above those usually included with the office visit or other services rendered"). Then list each and every specific product used.

Physician’s Order
a) What problems do you face pertaining to physician’s orders for debridement with your product?
For first-time users, review the package insert and educational support on the website before getting to the bedside.
b) What “ordering” recommendations do you have for providers who use your product?
Recommend using a pre-assembled dressing, whenever possible. Otherwise, be sure to order all of the necessary supplies in advance, because the maggots will not wait patiently on the wound until the therapists runs comes back with dressings to confine (cage) them.

Documentation for the Product/Procedure
Document need/indication, consent, and photographed progress.

Indications Covered
Medical Maggots were granted marketing clearance by FDA in 2004, for the following indications: “. . . debriding non-healing necrotic skin and soft-tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and non-healing traumatic or post surgical wounds.”

Medicare Audits
Has Medicare conducted any provider reimbursement audits pertaining to debridement?
The company is not aware of any.

Reimbursement Issues and Advice
a) Does your specific debridement product have any unique Medicare reimbursement issues?
While both AMA and CMS have publicly offered statements in support of maggot therapy, neither has been willing to provide a dedicated HCPCS code. AMA’s CPT Coding Committee recommends a standard debridement code (i.e., 97602) with a maggot-specific HCPCS (level II) code; while the CMS HCPCS Coding Committee recommends that AMA issue a maggot-specific CPT code that could include the cost of maggots and ancillary supplies when reimbursement is attached to that code. Thus far, neither AMA nor CMS has provided specific coding. Nevertheless, most insurers are covering the cost of the procedure and supplies (albeit, often not until filing a post-denial appeal).

The BTER Foundation and the manufacturer (Monarch Labs) provide Patient Assistance grants for patients with financial need and no insurance, or whose insurance carrier declines to pay.

b) What reimbursement advice would you like to offer to providers who utilize your debridement product for their patients?
Do not delay effective therapy due to fears of inadequate reimbursement. That would be unwise and unethical, given the relatively low cost of maggot therapy and the existence of multiple patient assistance grants to cover the cost, should insurance coverage not come through.

HCPCS Code for Product
a) If the debridement product has a CMS verified HCPCS code, please provide it and any directions that are relevant for the providers to remember when using the HCPCS code
N/A

Medicare Payment for the Product
a) What is the 2011Medicare payment rate for your debridement product?
N/A

CPT® Code for Procedure
a) If the debridement procedure has an AMA verified CPT® code, please provide it and any directions that are relevant for the providers to remember when using the CPT® code
According to AMA’s “CPT Advisor,” September 2008:
* Procedure (CPT) Code: 97602 ("Non-excisional debridement") (The service is often provided [bundled] with some other billable office code)
* Supply code: CPT® supply code 99070 ("Supplies and materials provided by the physician over and above those usually included with the office visit or other services rendered"). Then list each and every specific product used.

Medtrade products, ltd

Address:
Electra House
Crewe Business Park
Cheshire cw1 6gl
United Kingdom
Phone:
+44 (0) 1270 500019
Website:
www.medtrade.co.uk
Name of Products
omni-stat ® hemostatic agents
Contact:
andrew J. Davenport, CEO fianchetto Specialty products (us importer/distributor)
(267)965-2000
andrew.davenport@omni-stat.com
Description of Debridement Product including clinical trials, indications and contraindications.
See attached monograph
https://www.todayswoundclinic.com/files/Omni-Stat%20Customer%20Monograph…

Local Coverage Determination (LCD)
a) Do the providers use their Medicare contractor’s LCD as a guidance document for writing orders, utilization, and documentation of your debridement product?
No
b) What recommendations would you like to give the providers regarding the debridement LCDs?
NA

Physician’s Order
a) What problems do you face pertaining to physician’s orders for debridement with your product?
b) What “ordering” recommendations do you have for providers who use your product?
For minor bleeding:
If simple pressure for 5 minutes is ineffective, apply Omni-Stat Granules or Gauze as directed
For moderate/severe bleeding following debridement:
Immediately apply Omni-Stat Granules or Gauze as directed

Documentation for the Product/Procedure
a) What are the major documentation deficiencies that you encounter when providers use your product?
b) What documentation suggestions would you like to give providers who use your debridement?
Omni-Stat is used concomitantly with debridement device/procedures to safely and effective stop bleeding post-procedure. As such, application of Omni-Stat to achieve post-debridement hemostasis is not typically payable separately from the debridement procedure.

Indications Covered
a) Do you encounter any issues surrounding the indications that support medical necessity for debridement with your product?
b) Do you have any medical necessity suggestions to assist providers who use your product for debridement?
NA

Medicare Audits
a) Has Medicare conducted any provider reimbursement audits pertaining to debridement?
No
b) If yes, what were the issues audited?
c) If yes, what were the audit findings and recommendations?
N/A

Reimbursement Issues and Advice
a) Does your specific debridement product have any unique Medicare reimbursement issues?
Omni-Stat is presently not payable separately under Medicare Part B.
b) What reimbursement advice would you like to offer to providers who utilize your debridement product for their patients?
Some providers may reimburse Omni-Stat under the non-specific CPT code 99070.

HCPCS Code for Product
a) If the debridement product has a CMS verified HCPCS code, please provide it and any directions that are relevant for the providers to remember when using the HCPCS code
Omni-Stat has not yet been reviewed by Noridian for a HCPCS.

Medicare Payment for the Product
a) What is the 2011Medicare payment rate for your debridement product?
N/A

CPT® Code for Procedure
a) If the debridement procedure has an AMA verified CPT® [1] code, please provide it and any directions that are relevant for the providers to remember when using the CPT® code
N/A
Medicare Payment for the Procedure
a) What are the 2011 national average Medicare payment rates to the wound clinic and to the physicians for the debridement product/procedure?
N/A