Transcript Presentation to CMS on OPPS Payment of Integra Skin Products

Presentation to CMS on OPPS Payment
of Integra Skin Products
December 14, 2005
Agenda
• Introductions and Background
•
Dr. Cahn
• Clinical presentation
•
Dr. Gottlieb
• OPPS Coding and Payment Issues
•
Dr. Cahn
• Discussion
Participants
• Frederick Cahn, Ph.D.
•
•
•
CEO, BioMedical Strategies LLC, La Jolla, CA
Consultant to Integra Lifesciences Corporation
Chairman of ASTM International subcommittee F04.41 on Tissue Engineering
• Marc Gottlieb, M.D.
•
Plastic and Reconstructive surgeon from Phoenix, AZ
• Tom Tarca
•
VP Marketing - Reconstructive Surgery, Integra Lifesciences Corporation,
Plainsboro, NJ
• Judi O’Grady
•
VP Regulatory Affairs, Integra Lifesciences Corporation, Plainsboro, NJ
• Stuart Langbein
•
Hogan & Hartson, L.L.P., Washington, DC
Integra Skin Products
• Two Integra Products Are Identified by HCPCS
Code J7343
•
Integra Dermal Regeneration Template
•
PMA approval based on prospective clinical studies of lifethreatening burn wounds and a retrospective study of scar
revision surgery
•
Integra Bilayer Matrix Wound Dressing
•
510(k) clearance as a wound dressing
• Except for labeling, the products are identical
Dermal Regeneration Template
• INTEGRA Dermal Regeneration Template® is indicated
for the postexcisional treatment of life-threatening fullthickness or deep partial-thickness thermal injuries where
sufficient autograft is not available at the time of excision
or not desirable due to the physiological condition of the
patient.
• INTEGRA Dermal Regeneration Template® is also
indicated for the repair of scar contractures when other
therapies have failed or when donor sites for repair are
not sufficient or desirable due to the physiological
condition of the patient.”
Bilayer Matrix Wound Dressing
• Bilayer Matrix Wound Dressing is indicated for
the management of wounds including: partial and
full thickness wounds, pressure ulcers, venous
ulcers, diabetic ulcers, chronic vascular ulcers,
surgical wounds (donor sites/grafts, post-Moh's
surgery, post-laser surgery, podiatric, wound
dehiscence), trauma wounds (abrasions,
lacerations, second-degree burns, and skin tears)
and draining wounds. The device is intended for
one-time use.
Versitility of Integra
• Integra DRT and BMWD have clinical utility for a wide
variety of skin wounds
•
•
•
•
Burns
Trauma
Reconstructive surgery
Chronic wounds
• Both come in a wide range of sizes
•
•
•
•
8 x 10 inch
4 x 10 inch
4 x 5 inch
2 x 2 inch
• The larger sizes are used entirely in the inpatient setting
• The smaller sizes can be used in either setting
Skin Substitute Differentiation
• ASTM Standard Guide F2311-03
•
A Classification of Skin Substitutes by Clinical Use
• Used by AMA in CPT 2006 revision of Skin Replacement Surgery Codes
(15000-15431)
• Definition 5.3: Substitute for Skin Autograft for
Skin Replacement Surgery
•
Is applied to a clean surgical wound created by excision or incision (CPT
15000-15001)
• Wound healing by first intention
• Immediate wound closure
• Permanent skin replacement with intact healthy skin
Dr. Gottlieb’s Presentation
• Dr. Gottlieb’s presentation of clinical case studies
comes here
HOPPS Payment
• Integra products are disadvantaged
under OPPS
• APC classification for the procedure does not
represent the resources required for a grafting
procedure
• Separate payment for J7343 is inadequate
• 2006 CPT
• Expands skin grafting codes and differentiates skin
substitute procedures
• An opportunity to rationalize APC payments?
Coding and OPPS Payment (2005)
Procedure
CPT 2005
APC
Price
Excision 100 sq cm or less
15000
25
$269
Grafting 100 sq cm or less
CPT 15342
24
$101
Separate payment for 25 sq cm
HCPCS J7343
C9206
$10.69 x 25
$267
Oct 2005 Addendum A
CPT
2005
Procedure
APC
Price
15000 Skin graft (excision)
0025
269.62
15100 Skin split graft
0027
959.34
15120 Skin split graft (face, etc)
0027
959.34
15342 Cultured skin graft, 25 cm
0024
101.10
15350 Skin homograft
0686
320.11
15400 Skin heterograft
0025
269.62
2006 CPT
• New title “Skin Replacement Surgery and Skin
Substitutes”
• New codes differentiate “Acellular Dermal
Replacement,” Epidermal Autograft, Tissue
Cultured Epidermal Autograft, Tisue cultured
allogeneic skin substitute
• Acellular Dermal Replacement codes:
•
CPT 15170 Acellular Dermal Replacement, trunk, arms, leg, 100 sq cm
or less
• CPT 15171 each additional 100 sq cm
• CPT 15175 Acellular Dermal Replacement, face, scalp, eyelids, mough,
neck, ears, orbits, genitilia, hands, feet and or multiple digits, first 100 sq
cm
• CPT 15176 each additional 100 sq cm
CPT 2006
• “These codes are not intended to be
reported for simple graft application alone
or application stabilized with dressings
without surgical fixation of skin
subsitute/graft. The skin subsitute/graft is
anchored using the surgeon’s choice of
fixation.”
ASP Calculation (Q2 ’05)
Product
sq
cm
ASP
Units price/sq
Sold
cm
DRT 8 x 10
500
$2,912.54
390
$5.83
DRT 4 x 10
250
$1,858.48
174
$7.43
DRT 4 x 5
125
$1,063.12
69
$8.50
DRT 2 x 2
25
$625.00
1
$25.00
BMWD 8 .x 10
500
$3,054.91
302
$6.11
BMWD 4 x 10
250
$2,002.47
245
$8.01
BMWD 4 x 5
125
$1,551.59
321
$12.41
BMWD 2 x 2
25
$563.17
256
$22.53
Average
$10.09
106%
$10.694
CMS Payment vs. ASP (Q2 ’05)
sq cm
per unit
Average Sales
Price
Payment
DRT 8 x 10
500
$2,912.54
$5,347.05
DRT 4 x 10
250
$1,858.48
$2,673.52
DRT 4 x 5
125
$1,063.12
$1,336.76
DRT 2 x 2
25
$625.00
$267.35
BMWD 8 .x 10
500
$3,054.91
$5,347.05
BMWD 4 x 10
250
$2,002.47
$2,673.52
BMWD 4 x 5
125
$1,551.59
$1,336.76
BMWD 2 x 2
25
$563.17
$267.35
Product
Skin Substitute Payments
HCPCS Product
Price
C9206
Integra, per cm2
10.69
C9221
Graftjacket Reg Matrix
C9123
Transcyte, per 247 sq cm
711.68
C9200
Orcel, per 36 cm2
991.85
C9201
Dermagraft, per 37.5 sq cm
529.54
C1305
Apligraf
1307.48
1130.88
Conclusion
• Integra is a substitute for a skin autograft
• Enables closure of wounds where there are few
alternatives
• Current HOPPS payment methodology
•
Does not provide sufficient payment to cover procedure and product
costs in the outpatient setting
• Provides incentives to use other products that do not share the wound
closure abilities of Integra
• Provides incentives to utilize larger sizes inappropriately in the outpatient
setting