Presentation to CMS on OPPS Payment of Integra Skin Products

1
Presentation to CMS on OPPS Payment of Integra
Skin Products

• December 14, 2005

2
Agenda

• Introductions and Background
• Dr. Cahn
• Clinical presentation
• Dr. Gottlieb
• OPPS Coding and Payment Issues
• Dr. Cahn
• Discussion

3
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 OGrady
• VP Regulatory Affairs, Integra Lifesciences
  Corporation, Plainsboro, NJ
• Stuart Langbein
• Hogan Hartson, L.L.P., Washington, DC

4
Integra Skin Products

• Two Integra Products Are Identified by HCPCS Code
  J7343
• Integra Dermal Regeneration Template
• PMA approval based on prospective clinical
  studies of life-threatening 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

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Dermal Regeneration Template

• INTEGRA Dermal Regeneration Template is
  indicated for the postexcisional treatment of
  life-threatening full-thickness 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.

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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.

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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

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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

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Dr. Gottliebs Presentation

• Dr. Gottliebs presentation of clinical case
  studies comes here

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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?

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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
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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
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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

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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 surgeons
  choice of fixation.

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ASP Calculation (Q2 05)
Product sq cm ASP Units Sold price/sq 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
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CMS Payment vs. ASP (Q2 05)
Product 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
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Skin Substitute Payments
HCPCS Product Price
C9206 Integra, per cm2 10.69
C9221 Graftjacket Reg Matrix 1307.48
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 1130.88
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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