collagen based sterile membrane bio ... - helicoll-sfo.com€¦ · day 1 after helicoll day 5 after...
TRANSCRIPT
LEADERSHIP EXPERTISE
• Over 25 years of experience in healthcare
• 30 years experience in Tissue Regenerative Products
• 7 years experience in medical supply distributions
Manufactured & Marketed by:
4576 Enterprise Street, Fremont, CA – 94538 Tel.: +1 (510) 396-8581, Email: [email protected]
Helicoll
Leadership Expertise
Helicoll was chosen for their
“Innovative Technology Program”
HELICOLL WON THE INNOVATIVE AWARD ! AND PRICE CONTRACTED (MS7561) in JULY 2019.
Helicoll
GPO TM
Other collagen preparations yield random structural
configuration that is non-native and stays behind the bioactive
native HELICOLL.
Descriptive Advantages: US Patented acellular dermal replacement, pure, non-cross linked type-I
collagen with high bioactivity.
Faster Healing: Helicoll brings blood capillaries within 4 to 5 days for faster repair. Normally healed with 1 to 4 applications.
Good Esthetic Results: Helicoll provides better esthetic results upon healing.
Easy to use: Helicoll can be cut and sutured for easy use and no need to wash.
Diabetic Wound Care: Diabetic wound heals faster by glycosylative buffering effect of Helicoll.
Pain Reduction: Helicoll significantly reduces the pain and it is clinically proven.
Size options: Helicoll comes in all sizes to accommodate a wider range of wounds.
Cost Effectiveness: Faster healing and tissue remodeling makes Helicoll a cost effective product.
Long shelf life: Helicoll is usable for 3 years in room temperature conditions.
Helicoll
Advantages as a skin substitute TM
Collagen Phosphorylation and Bioactivity
• Encoll's patented process yields high purity Type-I Collagen for maximum biocompatibility.
• Such collagen when phosphorylated results in cell signal transduction. • Exceptional bioactivity of Helicoll collagen is derived due to its
phosphorylation
Helicoll FDA approved Indications US FDA K#040314 (Aug 2004) Medicare Recognized as a High Cost Skin Substitute - Q4164 (cont. since 2017)
Partial and full-thickness wounds
Pressure sores and venous ulcers
Chronic vascular ulcers
Diabetic ulcers
Trauma wounds (abrasions, lacerations, 2nd degree burns)
Surgical wounds, donor sites/grafts, Mohs' surgery,
Post laser surgery, podiatric surgery and wound dehiscence
• Upon opening up the Sterile package using scissors,
please open the folds first. • Helicoll is sandwiched between a transparent and a
white plastic sheet on either side. • Look for "Peel" sticker and remove the white plastic
sheet covering the edges. • Remove the clear plastic sheet as shown in the
picture.
Helicoll
Application Step 1 TM
• In a clean sterile bowl, pour enough sterile saline
solution. • Soak the entire product with the other backing
white plastic sheet in the Normal Saline solution for a minimum of 5 minutes.
Helicoll
Application Step 2 TM
• For larger wounds, apply the product with the white
plastic layer intact. Spread the sheet over the wound without wrinkles and air bubbles.
• For smaller wounds, you may remove the white plastic sheet before applying.
• Properly debride the wound. Use saline solution to wet dry wounds.
• Mild bleeding is preferred. Helicoll adheres to the wound instantly.
Helicoll
Application Step 3 TM
• Apply a non-adherent membrane like
Adaptec/Telfa before placing a secondary dressing to monitor without disturbing the Helicoll on days 2 and later.
• Smear over Helicoll any antibiotic cream or solution for prophylaxis as preferred by the doctor.
• To retain Helicoll in place, edges can be taped/sutured/stapled.
• For deep wounds, press down Helicoll using cotton gauze for intimate contact with the wound bed.
Helicoll
Application Step 4 TM
Day 10
Day 1 Day 5 Day 7
Granulation upon absorption of Helicoll Remarkable Recovery in Just 10 days
Stages of Healing Helicoll
TM
Helicoll
TM
Non-healing chronic wound Treatment
Non-Healing Leg Ulcer Wound. 77yr male Pt
Helicoll dressing on half of the Wound to access its efficacy
Significant improvement seen on the Helicoll covered portion of the wound.
Wound looked much better
at the Helicoll covered site.
Helicoll covered site was almost healed.
Helicoll covered site was totally healed. Helicoll applied on the remaining Wound.
Complete healing of initially covered part. Good Progress on later covered wound
5/24/2007
Helicoll applied
5/10/2007
Without Helicoll
5/3/2007
4/26/2007 3/26/2007
HELICOLL HELICOLL
HELICOLL
HELICOLL Healed part
4/12/2007
HELICOLL
Helicoll
TM
Non-healing chronic wound Treatment
Helicoll Prevented Re-occurring of Wound.
The healed wound remained well after several weeks follow up on
“This dressing can be recommended for the non-healing ulcer wound treatment”
Courtesy: Mathew Kelly, MD, Plastic Surgeon, Jan Parks, RN, St. Francis Memorial Hospital, San Francisco, CA.
13
Helicoll “kick starts” early wound healing process
After Helicoll application- acute inflammatory cells, fibroblasts and blood vessels proliferate into the collagen matrix.(50x). Absence of Lymphocytes evidences the collagen in Helicoll is not immunogenic.
Day 5: Neo-vascularization H & E light microscopy after Helicoll treatment
14
Wound Biopsy Helicoll
TM
16 Note: Intact tissue based membrane products (like OASIS™, EPIFIX™, AMNIOFIX™, CYTAL™) naturally contain at least 15% of high immunogenic compound namely Elastin,
besides other allergenic biological molecules like glycosaminoglycans and certain types of collagen other than type-I collagen.
HELICOLL™ COMPARISION WITH OTHER FDA APPROVED PRIME PRODUCTS
PRODUCT HELICOLL™ XWRAP® APLIGRAF® OASIS™ INTEGRA™ EPIFIX™ /
AMNIOFIX™ CYTAL™
Manufacturer ENCOLL Corp. Applied Biologics Organogensis Smith&Nephew Integra
LifeSciences MiMedX Acell
Matrix Patented high purity
bovine Type-I collagen,
Amniotic Membrane Derived Allograft
XWRAP
neonatal dermal fibroblast - on bovine
Type I collagen
Porcine small intestinal
submucosa (SIS)
Comprised of collagen and
glycosaminoglycan and a silicone
layer
Dehydrated Human Amnion/Chorion
Membrane Allograft
Porcine urinary Bladder
Xenograft
Size/shape 5x5 cm to 60x60 cm
& Custom sizes 1x1cm to 4x8cm sizes
Circular, 8 cm diameter, disc
3x3.5 cm to 7x20 cm in sizes
5x5 cm to 20x25 cm in sizes
2x2 cm to 4x6 cm in sizes
3x3.5 cm to 10x15 cm in sizes
Sterilization Terminal sterilization Terminal Sterilization Aseptically processed
Terminal sterilization Aseptically processed
Terminal sterilization Terminal sterilization
Shelf life 3 years at room
temperature 2 years &
Requires Refrigeration 5 days at room
temperature 2 years at room
temperature 1 year at room
temp. 5 years at room
temperature 2 years at room
temperature
Handling Rehydrates in saline in 5 min.; easily handled,
sutured & stapled Rehydrates in saline
Shipped on an nutrient medium; difficult to handle;
fragile
Rehydrates in saline; easily
sutured & stapled
Can be sutured & stapled; easily
handled
Can be sutured & stapled; easily
handled
Can be sutured & stapled; easily
handled
Large presence of immunogenic Elastin/ adverse biomolecules
No Yes (approx 15% elastin presence)
No Yes (approx 15% elastin presence)
Yes (significant amnt of GAGs)
Yes (approx 15% elastin presence)
Yes (approx 15% elastin presence)
Bioactivity expressed via neo-vascularizaion &
granulation
Within 4 to 5 days after application
(Clinically proven)
No report indicates lesser than 9 days
No report indicates lesser than 9 days
No report indicates lesser than 9 days
No report indicates lesser
than 9 days
No report indicates lesser than 9 days
No report indicates lesser than 9 days
Appllications to Heal 1-4 applications variable Up to 5 applications variable variable variable variable
Control of hyper glycosylation of Diabetic Foot
Ulcer Wounds to heal fast Yes No No No No No No
Total Advantages of the product 9 of 9 2 of 9 1 of 9 2 of 9 1 of 9 3 of 9 2 of 9
Differentiating code description based on 2020
CPT Code Total wound surface
area Areas of application
Size usage at the wound
surface
OPPS
payment rate
ASC Bundle
Rates
15271 up to 100 sq cm trunk, arms, legs 1st 25 sq cm or less $1,622.56 $819.95
+15272 up to 100 sq cm trunk, arms, legs additional 25 sq cm
15273 ≥ 100 sq cm trunk, arms, legs 1st 100 sq cm or 1% of body
area $2,976.96 $1,504.38
+15274 ≥ 100 sq cm trunk, arms, legs additional 100 sq cm
15275 up to 100 sq cm head, neck, hand, ft 1st 25 sq cm or less $1,622.56 $819.95
+15276 up to 100 sq cm head, neck, hand, ft additional 25 sq cm
15277 ≥ 100 sq cm head, neck, hand, ft 1st 100 sq cm or 1% of body
area $1,622.56 $819.95
+15278 ≥ 100 sq cm head, neck, hand, ft additional 100 sq cm
Medicare OPPS & ASC Payment rate for CPT 15271 to 15278 Helicoll
TM
JC Recognizes the product as a graft JW To document the amount of product wasted or un-used.
KX Met the requirements in the medical policy. Coverage criteria for the DMEPOS billed and the Medical Necessity are met.
25 Separate evaluation and management [E/M] service by the same physician on the same day of the procedure
59 Independent procedure or service performed from other non-E/M service performed on the same day.
76 Repeat procedure or service that is non-overlap performed by the same physician on the same day.
XE subset of 59 Service that is occurred during a separate encounter
XP subset of 59 Service performed by a different practitioner
XS subset of 59 Service performed on a separate organ/structure
XU subset of 59 an unusual non-overlapping service.
TA Right foot, great toe defect Treatment TG Left foot, great toe defect Treatment
Common Modifiers Helicoll
TM
Units Billed: Example Helicoll Q4164 (2x2 inches) is billed as 25 units.
Wound Size/Location: Required to select the appropriate CPT code.
Debridement: Debridement has a CPT code and amount when skin substitute applied.
Product Wastage Documentation: Note Product unit use and discarded quantities.
Diagnosis Code: Note ICD10 diagnostic codes on Insurance claims forms.
Modifiers: Enter Modifiers required with HCPCS Q4164 and/or the CPT codes used.
Commercial Insurers/Contracted Rates: Refer to general fee schedule rate or if required get prior authorization from payer.
Medical Necessity/Documentation: Provider review clinical details of Helicoll and follow if there is an applicable LCD or medical policy
for Helicoll to meet all requirements.
Billing Reminders Helicoll
TM