reimbursement guide 2019 · skinte is fda-registered as a human cells, tissues and cellular and...

FOR MEDICAL PROVIDERS | www.PolarityTE.com | PTE.Cool/SkinTE

SkinTE is a human cellular and tissue-based product derived from a patient’s own skin to regenerate full-thickness, functionally-polarized skin with all of its layers (epidermis, dermis and hypodermis) and appendages, including hair follicles and glands.

For the Autologous Homologous Treatment of Skin Tissue1

• Wounds (acute & chronic)• Surgical reconstruction events• Burns (acute, subacute & burn

reconstruction)

• Scar revision• Traumatic injuries• Replacement of skin grafts

or failed flap coverage

For the Repair, Reconstruction & Replacement of Full-Thickness Skin

1. Conditions treated with SkinTE

Where Self Regenerates Self®

®

Part No. STE-RIG-100; Rev No. 01

Reimbursement Guide 2019PolarityTE Customer Service:Tel: 1-800-560-3383

PolarityTE Reimbursement Hotline:Tel: 1-800-284-0262Email: [email protected]

© 2019 PolarityTE, Inc. All rights reserved. All trademarks used herein are trademarks of their respective owners.2

Table of Contents

1. Reimbursement Disclaimer ........................................................................................................................................................................................................................................................3

2. Mission Statement ............................................................................................................................................................................................................................................................................4

3. SkinTE Product Description.........................................................................................................................................................................................................................................................5

4. SkinTE Process Overview ..............................................................................................................................................................................................................................................................5

5. SkinTE Regulatory Classification ...............................................................................................................................................................................................................................................5

6. Intended Use .......................................................................................................................................................................................................................................................................................5

7. Harvest Size ..........................................................................................................................................................................................................................................................................................5

8. Deployment Size ...............................................................................................................................................................................................................................................................................5

9. Product Wastage ...............................................................................................................................................................................................................................................................................5

10. SkinTE Coding Information .........................................................................................................................................................................................................................................................6

11. Pre-Authorization Instructions and Sample Letter .................................................................................................................................................................................................... 13

12. Spectrum of Wounds .................................................................................................................................................................................................................................................................. 15

13. SkinTE Coding & Payment Guide .......................................................................................................................................................................................................................................... 17


PolarityTE provides this coding guide for informational purposes only and it is subject to change without notice. This guide is not an affirmative instruction as to which codes and modifiers to use for a particular service, supply, procedure or treatment and does not constitute advice regarding coding, coverage, or payment for PolarityTE products. It is the responsibility of providers, physicians and suppliers to determine and submit appropriate codes, charges and modifiers for products, services, supplies, procedures, or treatment furnished or rendered. Providers, physicians and suppliers should contact their payers for specific and current information on their coding, coverage, and payment policies. For further detailed product information, including indications for use, contraindications, effects, precautions and warnings, please consult the product’s Instructions for Use (IFU) prior to use. The information provided herein is without any other warranty or guarantee of any kind, expressed or implied, as to completeness, accuracy, or otherwise. This information is intended only to help estimate payment rates and product costs in each clinical setting. All rates shown are national average Medicare rates, have not been adjusted for geographic variations in payment or other factors, such as sequestration, and are subject to change without notice.

Reimbursement Disclaimer


Mission Statement

The PolarityTE Company ValuesOur Goal • Our Cause • Our Belief • Our Priority

We are a company created by providers, for providers and the patients we serve. Our founders left the practice of academic medicine and scientific research to be able to serve more patients on a greater scale. Patients, providers and improvement of the human condition is at the center of our work. This mission defines who we are.

• The Patient First: Our absolute, first priority will always be the incredible patients treated with our products, recognizing it is an honor and privilege for our products to be used in their care.

• Complex Simplicity and Pragmatism: We aim to deliver effective, tangible and pragmatic products for patients, providers and payers. We will not allow the complexity of the science or the health care industry to deter us from finding pragmatic and simple solutions to achieve our mission.

• Barrier Reduction and Clinical Utility: Our products will be designed for easy use by all clinical stakeholders to promote better care of patients with better efficiency.

• Cost Reduction and Improved Health Economics: Our products will be economical and cost effective for patients, providers and payers.

• Effective and Sensible Reimbursement: Our products should integrate into reimbursement systems in a manner that is sensible to all stakeholders.

PolarityTE Reimbursement Hotline:Tel: 1-800-284-0262

Email: [email protected]

PolarityTE Customer Service:Tel: 1-800-560-3383


SkinTE is a fully autologous (from the patient for the patient) homologous (performing the same basic functions of skin tissue) skin construct intended to be used by physicians or other appropriate health care providers for homologous uses of the skin and integumentary system. Patients who have suffered from an event, disease, process or who have an acquired defect that has resulted in the functional loss or absence of the skin and integumentary system can use SkinTE as an adjunct and/or in place of split-thickness skin grafting, full-thickness grafting, temporizing skin coverage, skin substitute products or even vascularized free tissue transfer in some cases. Each SkinTE is intended for autologous use that is patient-specific, a single application and contains no allogeneic or xenogeneic tissue. SkinTE has been shown to regenerate permanent full-thickness (epidermis, dermis, hypodermis), hair-bearing skin with all its associated appendages.

SkinTE is processed aseptically under current Good Tissue Practice (cGTP) in a controlled clean room environment at an FDA-registered manufacturing facility. SkinTE manufacturing follows the rigorous quality control testing per FDA regulations.

Regulatory:SkinTE is FDA-registered as a human cells, tissues and cellular and tissue-based product (HCT/P) marketed solely under Section 361 of the Public Health Service Act and its implementing regulations under 21 CFR 1271. PolarityTE is registered with the U.S. Food and Drug Administration (FDA) as a tissue establishment for SkinTE. SkinTE is manufactured under Current Good Tissue Practice (cGTP) guidelines compliant per FDA regulations.

Intended Use:SkinTE is intended to be used by licensed medical professionals for homologous uses of skin tissues which may include the repair, reconstruction, replacement or supplementation of skin tissues and the integumentary system. SkinTE may be used to treat patients who have suffered from an event, disease, process or acquired deficit that results in the functional loss or void of skin tissues and the integumentary system in place of or in combination with split-thickness grafting, full-thickness grafting, temporizing skin coverage and/or skin substitute products. SkinTE has been used for the autologous, homologous treatment of skin tissue in the following conditions:

• Wounds (acute & chronic)

• Surgical reconstruction events

• Burns (acute, subacute & burn reconstruction)

• Scar Revision

• Traumatic Injuries

• Replacement of skin grafts or failed flap coverage

Harvest Size:SkinTE is manufactured from a small harvest sample of the patient’s full-thickness skin which is dependent on wound defect size and is shipped back to an FDA-registered manufacturing facility. The quantity of SkinTE developed is patient-specific and customized based upon the patient’s wound defect size. A 1 cm2 full-thickness skin harvest can generate SkinTE which can cover up to 10% of the patient’s total body surface area (TBSA). The application of SkinTE is a single application with no wastage. SkinTE can be returned as soon as the same day of harvest but is typically shipped back to the provider within 48–72 hours.

Deployment Size:SkinTE is supplied as an autologous, homologous skin product in an amount appropriate for the target wound surface area for treatment and is spread evenly across the treatment area. Following SkinTE application across the wound bed, it is secured in place per standard of care for skin grafting procedures and dressed accordingly.

Product Wastage:SkinTE is manufactured based on each individual patient’s wound size. The development of the autologous homologous skin product is customized for each patient’s defect, therefore, no wastage of product.

SkinTE™ Product Description

The Process for SkinTE Use is as Simple as:

1. Harvest Skin Specimen: Provider harvests a small piece of full-thickness skin and places the specimen in a provided PolarityTE Harvest shipping container and sends back to PolarityTE.

2. Manufacture SkinTE: The patient-specific skin harvest specimen is utilized to manufacture the SkinTE cell-tissue product in a PolarityTE manufacturing facility.

3. Ship SkinTE to Provider: The skin product is contained within a syringe and is then returned back to the provider and patient, typically within two days.

4. Apply SkinTE to Wound Defect: The patient-specific SkinTE product arrives in an all-inclusive SkinTE Deployment Box at the chosen facility and is applied to a prepared wound bed and dressed with included materials.




1

2

3 4


SkinTE Product Code

The Healthcare Common Procedure Coding System (HCPCS) level II codes are used for the reporting and billing of non-physician services. SkinTE has a unique product HCPCS code that was established January 1, 2019.

Current Procedural Terminology (CPT®) Coding

The Current Procedural Terminology (CPT) code set describes medical, surgical and diagnostic services and is maintained by the American Medical Association. These codes are designed to communicate standardized information about medical services and procedures.

The application of SkinTE is performed in two phases: a harvest phase and a deployment phase. The selection of an appropriate CPT code is based on the location and size of the patient’s wound defect and supported by the patient’s medical record. CPT add-on codes and modifiers may also be applicable.

Some CPT codes contain add-on codes for additional same procedures. These codes must be reported along with the primary procedure codes. Coding modifiers may also apply. Coding modifiers according to the AMA and CMS provides the means to report that a service or procedure has been performed or altered by some specific circumstance without changing the definition of the code. Due to the staged nature of the SkinTE service, it may be appropriate to report modifiers in addition to the procedure codes to identify reduced services or staged procedures. Please check with the patient’s insurer or Medicare Administrative Contractor (MAC) to inquire if modifiers are required with the CPT codes used. Potential CPT codes and modifiers are listed below.

SkinTE Coding Information

HCPCS1 Code Product Description SkinTE Product Size Billable Units

Q4200 SkinTE Per cm2 of defect treated 1 unit per 1 cm2 treated

Possible Modifier2 Description

-52 Reduced Services; “service or procedure is partially reduced or eliminated at the discretion of the physician”

-58Staged or Related Procedure or Service by the Same Provider or Other Qualified Health Care Professional During the Postoperative Period; “Performance of a procedure or service during the postoperative period was planned or anticipated (staged)”

1. Centers for Medicare and Medicaid Services, 2019 Alpha-Numeric HCPCS File, available at https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Alpha-Numeric-HCPCS.html2. American Medical Association, 2018 CPT Manual: Appendix A, Modifiers.

The above modifiers are provided for informational purposes only and may be subject to change without notice. Actual modifiers used are at the sole discretion of the treating provider and/or facility. PolarityTE does not guarantee medical benefit coverage or reimbursement with the codes listed in this guide


Physician Procedure Codes

CPT©1 Description RVU2 Physician Facility2

Physician Non-Facility2

Cultured Autograft

15040 Harvest skin for tissue cultured autograft, 100 cm2 or less 2.00 $130.46 $262.73

15150 Tissue cultured skin autograft, trunk, arms, legs; 25 cm2 or less 9.39 $660.24 $722.58

+15151 Additional 1 cm2 to 75 cm2 2.00 $114.96 $124.33

+15152 Additional 100 cm2, or each additional 1% BSA of infants and children, or part thereof 2.50 $143.44 $153.17

15155Tissue cultured skin autograft, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet and/or multiple digits; first 25 cm2 or less

10.14 $758.62 $823.13

+15156 Additional 1 cm2 to 75 cm2 2.75 $157.85 $167.58

+15157 Each additional 100 cm2 or each additional 1% BSA of infants and children 3.00 $172.27 $186.32

Split-Thickness Graft

15100 Split-thickness autograft, trunk, arms, legs; first 100 cm2 or less, or 1% of BSA of infants and children 9.90 $739.88 $85.84

+15101 Each additional 100 cm2, or each 1% BSA of infants and children, or part thereof 1.72 $116.05 $191.37

15120Split-thickness autograft, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet and/or multiple digits; first 100 cm2 or less, or 1% BSA of infants and children

10.15 $721.14 $875.39

+15121 Each additional 100 cm2, or each 1% BSA of infants and children, or part thereof 2.00 $139.11 $214.43

Full-Thickness Graft

15200 Full-thickness graft, free, including direct closure of donor site, trunk; 20 cm2 or less 9.15 $697.00 $858.81

+15201 Each additional 20 cm2 (list separately in addition to code for primary procedure) 1.32 $81.45 $149.20

15220 Full-thickness graft, free, including direct closure of donor site, scalp, arms and/or legs; 20 cm2 or less 8.09 $636.81 $795.02


15240Full-thickness graft, free, including direct closure of donor site, forehead, cheeks, chin, mouth, neck, axillae, genitalia, hands and/or feet; 20 cm2 or less

10.41 $829.26 $961.52


15260 Full-thickness graft, free, including direct closure of donor site, nose, ears, eyelids and/or lips; 20 cm2 or less 11.64 $888.36 $1,040.81


Skin Substitute

15271Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 cm2; first 25 cm2 or less wound surface area

1.50 $87.21 $149.20

+15272Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 cm2; each additional 25 cm2 wound surface area or part thereof (list separately in addition to code for primary procedure)

0.33 $18.02 $27.39

15273Application of skin substitute graft to trunk, legs, total wound surface area greater than or equal to 100 cm2; first 100 cm2 wound surface area, or 1% BSA of infants and children

3.50 $210.47 $314.62

+15274Application of skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 cm2; each additional 100 cm2 wound surface area, or part thereof, or each additional 1% BSA of infants and children, or part thereof (list separately in addition to code for primary procedure)

0.80 $47.93 $77.48

15275Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet and/or multiple digits, total wound surface area up to 100 cm2; first 25 cm2 or less wound surface area

1.83 $98.75 $157.49

1. Current Procedural Terminology (CPT) is a registered trademark of the American Medical Association (AMA). Copyright 2017 AMA. All rights reserved.2. The Medicare National Facility and Non-Facility Provider payments and RVUs provided in the table above are national averages and are to be used as reference only.

Continued


Physician Procedure Codes (continued...)


Physician Non-Facility2

Skin Substitute (continued...)

+15276Application of skin substitute graft to face scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet and/or multiple digits, total wound surface area up to 100 cm2; each additional 25 cm2 wound surface area, or part thereof (list separately in addition to code for primary procedure)

0.50 $26.31 $35.32

15277Application of skin substitute graft to face scalp eyelids, mouth, neck, ears, orbits, genitalia, hands, feet and/or multiple digits, total wound surface area up to 100 cm2; first 100 cm2 wound surface area, or 1% BSA of infants and children

4.00 $237.86 $344.17

+15278Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet and/or multiple digits, total wound surface area up to 100 cm2; each additional 100 cm2 wound surface area, or part thereof, or 1% BSA of infants and children (list in addition to code for primary procedure)

1.00 $59.82 $91.54

Other

17999Unlisted procedure, skin, mucous membrane and subcutaneous tissue [possible code when others do not adequately describe procedure performed and may involve providing a special report]

— — —

1. Current Procedural Terminology (CPT) is a registered trademark of the American Medical Association (AMA). Copyright 2017 AMA. All rights reserved.2. The Medicare National Facility and Non-Facility Provider payments and RVUs provided in the table above are national averages and are to be used as reference only.


ICD-10 Diagnosis Codes:

The International Classification of Diseases, 10th edition, Clinical Modification (ICD-10) is used to report diagnoses and procedures and contains a high level of specificity. Please see the ICD-10 PCS reference list1 for specific ICD-10 codes.

DRG Coding Information:

Medicare uses a Prospective Payment System to reimburse hospitals for inpatient services based on Medicare Severity-Diagnosis-Related Group (MS-DRG) classification system. Services are classified into clinical cohesive groups that exhibit similar use of hospital resources. Hospitals receive a single payment for all services provided during an inpatient admission. Only one DRG is assigned. Assignment to the categories of Complication or Comorbidities (CCs) and/or Major Complications or Comorbidities (MCC) is influence by the medical record documentation describing the hospital admission. Potentially relevant MS-DRG codes for SkinTE and the national average Medicare payment rate are listed below.

Hospital Inpatient Codes

Hospital Inpatient Diagnosis Related Groupings (DRG)

Possible MS-DRG MS-DRG Title

Medicare National

Average Rate2

463 Wound debridement and skin graft except hand, for musculo-connective tissue disorders with major complications or comorbidities $28,577.96

464 Wound debridement and skin graft except hand, for musculo-connective tissue disorders with complications or comorbidities $16,394.22

465Wound debridement and skin graft except hand, for musculo-connective tissue disorders without complications or comorbidities or major complications or comorbidities

$10,231.91

573 Skin graft for skin ulcer or cellulitis with major complications or comorbidities $29,243.98

574 Skin graft for skin ulcer or cellulitis with complications or comorbidities $16,961.67

575 Skin graft for skin ulcer or cellulitis without complications or comorbidities or major complications or comorbidities $9,793.10

576 Skin graft except for skin ulcer or cellulitis with major complications or comorbidities $27,179.11

577 Skin graft except for skin ulcer or cellulitis with complications or comorbidities $13,972.96

578 Skin graft except for skin ulcer or cellulitis without complications or comorbidities or major complications or comorbidities $8,518.43

622 Skin grafts and wound debridement for endocrine, nutritional and metabolic diseases with major complications or comorbidities $21,149.88

623 Skin grafts and wound debridement for endocrine, nutritional and metabolic diseases with complications or comorbidities $10,709.70

624Skin grafts and wound debridement for endocrine, nutritional and metabolic diseases without complications or comorbidities or major complications or comorbidities

$7,217.02

904 Skin grafts for injuries with complications or comorbidities or major complications or comorbidities $17,964.59

905 Skin grafts for injuries without complications or comorbidities or major complications or comorbidities $9,852.13

927 Extensive burns or full thickness burns with mechanical ventilation > 96 hours with skin graft $102,377.58

928 Full-thickness burn with skin graft or inhalation injury with complication or comorbidities or major complications or comorbidities $32,719.39

929 Full-thickness burn with skin graft or inhalation injury without complication or comorbidities or major complications or comorbidities $16,551.26

957 Other operating room procedures for multiple significant trauma with major complications or comorbidities $42,313.69

958 Other operating room procedures for multiple significant trauma with complication or comorbidities $23,276.01

959 Other operating room procedures for multiple significant trauma without major complications or comorbidities $13,647.19

1. The 2019 ICD-10 Procedure Coding System (ICD-10-PCS) is available at https://www.cms.gov/Medicare/Coding/ICD10/2019-ICD-10-PCS.html2. The Medicare National Average Rates provided in the table above are approximate and are to be used as reference only.


1. Current Procedural Terminology (CPT) is a registered trademark of the American Medical Association (AMA). Copyright 2017 AMA. All rights reserved.2. APC – Ambulatory Payment Classification3. The Medicare National Average Rates provided in the table above are approximate and are to be used as reference only.

Hospital Outpatient Department (HOPD)/Ambulatory Surgical Center (ASC)

© 2019 PolarityTE, Inc. All rights reserved. All trademarks used herein are trademarks of their respective owners.

Hospital Outpatient and Ambulatory Surgical Center Coding and Payment

CPT©1 Description APC2APC National

Medicare Payment3

ASC National Medicare Payment3

Cultured Autograft

15040 Harvest skin for tissue cultured autograft, 100 cm2 or less 5054 $1,548.96 $797.53

15150 Tissue cultured skin autograft, trunk, arms, legs; 25 cm2 or less 5054 $1,548.96 $797.53

+15151 Additional 1 cm2 to 75 cm2 — — —

+15152 Additional 100 cm2, or each additional 1% BSA of infants and children, or part thereof — — —

15155Tissue cultured skin autograft, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet and/or multiple digits; first 25 cm2 or less

5055 $2,766.13 $1,424.22

+15156 Additional 1 cm2 to 75 cm2 — — —

+15157 Each additional 100 cm2 or each additional 1% BSA of infants and children — — —


15100 Split-thickness autograft, trunk, arms, legs; first 100 cm2 or less, or 1% BSA of infants and children 5054 $1,548.96 $797.53

+15101 Each additional 100 cm2, or each 1% BSA of infants and children or part thereof — — —

15120Split-thickness autograft, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet and/or multiple digits; first 100 cm2 or less, or 1% BSA of infants and children

5055 $2,766.13 $1,424.22

+15121 Each additional 100 cm2, or each 1% BSA of infants and children or part thereof — — —


15200 Full-thickness graft, free, including direct closure of donor site, trunk; 20 cm2 or less 5054 $1,548.96 $797.53

+15201 Each additional 20 cm2 (list separately in addition to code for primary procedure) — — —

15220 Full-thickness graft, free, including direct closure of donor site, scalp, arms and/or legs; 20 cm2 or less 5054 $1,548.96 $797.53



5054 $1,548.96 $797.53


15260 Full-thickness graft, free, including direct closure of donor site, nose, ears, eyelids and/or lips; 20 cm2 or less 5054 $1,548.96 $797.53


Skin Substitute

C5271Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 cm2; first 25 cm2 or less wound surface area

5053 $482.89 $248.63

+C5272 Each additional 25 cm2 wound surface area or part thereof (list separately in addition to code for primary procedure) — — —

C5273Application of skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 cm2; first 100 cm2 wound surface area, or 1% BSA of infants and children

5054 $1,548.96 $797.53

Payment in the Outpatient setting (HOPD/ASC) is governed by the Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) Payment System. Specific CPT codes are cross walked to specific facility payments under the Ambulatory Payment Classification (APC) and ASC. SkinTE is currently bundled into the facility payments for these procedures, and there is no separate payment. Providers and facilities should use the CPT codes and corresponding APC codes that are most relevant and appropriate for the procedures performed for both the harvest and deployment phases when using SkinTE.

Continued


Hospital Outpatient Department (HOPD)/Ambulatory Surgical Center (ASC)

Hospital Outpatient and Ambulatory Surgical Center Coding and Payment

CPT©1 Description APC2APC National

Medicare Payment3


Skin Substitute (continued...)

+C5274Each additional 100 cm2 wound surface area, or part thereof, or each additional 1% BSA of infants and children, or part thereof (list separately in addition to code for primary procedure)

— — —

C5275Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet and/or multiple digits, total wound surface area up to 100 cm2; first 25 cm2 or less wound surface area

5053 $482.89 $248.63

+C5276 Each additional 25 cm2 wound surface area, or part thereof (list separately in addition to code for primary procedure) — — —

C5277Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet and/or multiple digits, total wound surface area greater than or equal to 100 cm2; first 100 cm2 wound surface area, or 1% BSA of infants and children

5053 $482.89 $248.63

+C5278Each additional 100 cm2 wound surface area, or part thereof, or each additional 1% BSA of infants and children or part thereof (list separately in addition to code for primary procedure)

— — —

Other


5051 $176.45 —




1. Current Procedural Terminology (CPT) is a registered trademark of the American Medical Association (AMA). Copyright 2017 AMA. All rights reserved.2. APC – Ambulatory Payment Classification3. The Medicare National Average Rates provided in the table above are approximate and are to be used as reference only.


Payers

Commercial Payers:

Commercial payers have specific policies and contracts for reimbursing products and services. It is recommended that providers seek prior authorization from insurance providers prior to use of SkinTE.

Pre-Authorization: Below is a sample prior authorization letter and a list of suggested materials to be included in the prior authorization letter to the patient’s insurance.

Medicare:

Medicare has specific policies in place for procedures and products and it is recommended that providers contact their local Medicare Administrative Contractor for any questions regarding SkinTE. For any further questions, please contact PolarityTE’s Reimbursement Hotline.

Resources:

PolarityTE has established reimbursement resources, which include the PolarityTE Reimbursement Hotline: 1–(800) 284–0262. Personnel can assist in coding, coverage, reimbursement and prior-authorization information. In addition, pre-authorization instructions and a sample prior authorization template letter are included below.





It is recommended that a provider seek pre-authorization from the patient’s private insurance carrier to facilitate coverage for a proposed procedure. Below is a sample prior authorization letter which contains a list of suggested figures and references to be included.

Sample Prior Authorization Letter

[DATE]

[NAME OF INSURANCE COMPANY][ATTN:][FAX #:]

RE: [PATIENT NAME][INSURANCE IDENTIFICATION NUMBER][DATE OF BIRTH]

Dear Medical Director,

I am writing this letter as a pre-authorization request to provide an autologous homologous skin product to my patient [NAME Jane Doe]. This patient has a defect located on [defect location]. Conservative methods of treatment and standard of care therapy have failed in providing adequate healing, and it is medically necessary to change the plan of care and use the autologous, homologous skin product at this time.

[PATIENT NAME] medical history is the following:

• [AGE] [GENDER] who presented to me with [DESCRIBE SYMPTOMS WITH SPECIFICITY].

• [PRIMARY DX:]

• This patient’s comorbidities of [DESCRIBE, SUCH AS DIABETES, ETC.] have impacted the healing process.

• Prior treatments have included [DESCRIBE CONSERVATIVE CARE, USE OF MEDICATIONS, PRIOR TREATMENTS].

• Factors that influence healing have been addressed: [ i.e. VASCULAR STATUS, NUTRITIONAL STATUS, INFECTION, ETC.]

• The size of the patient’s defect [LENGTH (CM) X WIDTH (CM) X DEPTH (CM)] over the course of treatment

I believe the best course of treatment and medical necessity for this patient is the application of SkinTE™, the only currently available autologous homologous skin product, and it will provide a clinically effective and cost-effective therapy.

SkinTE is a fully autologous (from the patient for the patient), homologous (performing the same basic functions of skin tissue) cutaneous construct which facilitates the regeneration of permanent full-thickness skin and is intended for the repair, reconstruction and replacement of skin. SkinTE is regulated by the U.S. Food and Drug Administration (FDA) as a human skin tissue under its Human Cells, Tissues and Tissue-Based Products (HCT/P) guidelines.

The procedure to create and apply SkinTE involves harvest of a small full-thickness skin graft from an area of the patient’s healthy skin. This small harvest is sent to an FDA-regulated manufacturing facility where it is developed into SkinTE, shipped back to the provider to deploy in a single application, then secured over the wound bed and dressed accordingly. SkinTE is personalized for each patient’s wound size and allows for no product wastage. The use of this autologous homologous skin product will allow me to treat this patient [IN THE PRACTICE SETTING] and avoid other more costly therapies such as [WEEKLY APPLICATIONS OF A SKIN SUBSTITUTE OR ADVANCED WOUND CARE THERAPY OR USE OF OPERATING ROOM TIME AND RESOURCES FOR SKIN GRAFTING].

SkinTE is able to generate complete epithelial coverage and full-thickness skin demonstrating cutaneous appendages. Please refer to the included references and figures which showcase the spectrum of wounds treated with SkinTE. Should you have further questions or require additional information, please do not hesitate to call me.

Thank you for your immediate attention and anticipated authorization of these services for your insured member.

Sincerely,

[PHYSICIAN NAME], MD[PHONE NUMBER][BOARD CERTIFICATION][IN NETWORK]Tax ID:NPI #:

Enclosure: Medical records

Please include the references and figures below in your submission.

Pre-Authorization Instructions


Lough, D.M., Wetter, N., Madsen, C., Reichensperger, J., Cosenza, N., Cox, L., Harrison, C., Neumeister, M.W. Transplantation of an LGR6+ Epithelial Stem Cell-Enriched Scaffold for Repair of Full-Thickness Soft-Tissue Defects: The In Vitro Development of Polarized Hair-Bearing Skin. 2016. Plastic and Reconstructive Surgery. 137:495

Lough, D.M., Yang, M., Blum, A., Reichensperger, J.D., Cosenza, N.M., Wetter, N., Cox, L.A., Harrison, C.E., Neumeister, M.W. Transplantation of the LGR6+ Epithelial Stem Cell into Full-Thickness Cutaneous Wounds Results in Enhanced Healing, Nascent Hair Follicle Development, and Augmentation of Angiogenic Analytes. 2014. Plastic and Reconstructive Surgery. 133:579

Lough, D., Dai, H., Yang, M., Reichensperger, J., Cox, L., Harrison, C., Neumeister, M.W. Stimulation of the Follicular Bulge LGR5+ and LGR6+ Stem Cells with the Gut-Derived Human Alpha Defensin 5 Results in Decreased Bacterial Presence, Enhanced Wound Healing, and Hair Growth from Tissues Devoid of Adnexal Structures. 2013. Plastic and Reconstructive Surgery. 132:1159

Podium PresentationsMundinger, G., Sharma, S., Patterson, C., Neumeister, M., Nahabedian, M., Swanson, E., Sopko, N. Soft tissue reconstruction of complex lower extremity wounds with exposed deep structures utilizing an autologous homologous skin construct in pediatric cases. 2019 February. 41st Annual Boswick Burn & Wound Symposium. Maui, HI

Sopko, N., Mathis, R., Nahabedian, M., Neumeister, M., Swanson, E., Granick, M. From bench to bedside: Full-thickness skin and associated dermal appendages regenerated in complex cutaneous wounds treated with an Autologous Homologous Skin Construct. 2019 February. 41st Annual Boswick Burn & Wound Symposium. Maui, HI

Mundinger, G., Sailon, A., Tamagnini, G., Sopko, N., Nahabedian, M., Neumeister, M., Granick, M. A Full thickness hair-bearing skin replacement for burn injuries and acute and chronic cutaneous defects using an autologous homologous skin construct: A Clinical Case Series. 2019 February. 41st Annual Boswick Burn & Wound Symposium. Maui, HI

Sopko, N., Krishnan, N., Yalanis, G., Miller, D., Baetz, N., Mathis, R., Labroo, P., Garrett, C., Swanson, E., Nahabedian, M., Milner, S., Granick, M. Regeneration of Full Thickness Hair-Bearing Skin in Chronic Refractory Wounds with an Autologous Homologous Skin Construct: Preclinical and Clinical Experience. 2018 September. American Professional Wound Care Association Annual Meeting. Baltimore, MD

Mundinger, G.S and Patterson, C.W. Replacement of Contracted Split-Thickness Skin Graft and Keloid Scar with a Self-Propagating Autologous Skin Construct (SkinTETM). 2018 September. Plast Reconstr Surg Glob Open. 6(9 Suppl): 95. PMCID: PMC6211943

Poster PresentationsLabroo, P., Irvin, J., Baetz, N., Robinson, I., Meiss, J., Sieverts, M., Miller, D., Sopko, N. Extracellular matrix functionalized multi-cell aggregate for wound repair. 2019 April. Society for Biomaterials. Seattle, WA

Swanson, E., Sailon, A., Tamagnini, G., Sopko, N., Mundinger, G. Neo-generation of functional skin within acute and chronic complex wounds with exposed tendon and bone using an autologous homologous skin construct. 2019 February. 41st Annual Boswick Burn & Wound Symposium. Maui, HI

Mundinger, G., Sailon, A., Tamagnini, G., Nahabedian, M., Neumeister, M., Granick, M., Krishnan, N., Swanson, E., Sopko, N. Full closure of complex cutaneous defects using an autologous homologous skin construct in acute burns, burn reconstruction, acute trauma, and chronic wound cases. 2019 February. 41st Annual Boswick Burn & Wound Symposium. Maui, HI

Baetz, N., Labroo, P., Irvin, J., Roth, S., Miller, D., Yalanis, G., Sopko, N. Neogeneration of fully-functional bone and skin with minimally polarized functional units in an autologous homologous tissue construct. 2019 January. World Stem Cell Summit – Regenerative Medicine Foundation. Miami, FL

Sailon, A., Tamagnini, G., Sopko, N., Mundinger, G. Closure of Acute and Chronic Complex Wounds Involving Exposed Tendon and Bone with Full-Thickness Skin using an Autologous Homologous Skin Construct. 2018 December. Innovations in Wound Healing Annual Meeting. Key West, FL

Publications1




1. The following publications are representative of the potency and capability of the LGR stem cell population (in single cell suspension) as shown in pre-clinical models. For information related specifically to PolarityTE’s novel use of LGR stem cell populations to regenerate functional polarized tissue, please see PolarityTE’s pending patent applications, including but not limited to US 2016/0151540.


Spectrum of Wounds

Initial Wound: The patient suffering from necrotizing fasciitis was left with an open wound with exposed muscle and tendon over his right lower extremity following surgical debridement. Refractory wounds following split-thickness skin grafting were treated with SkinTE in the provider’s clinic.

Mid-Stage Healing of SkinTE: Three months following the single application of SkinTE in the clinic, the patient returned for routine follow-up. SkinTE regenerated full-thickness, functional skin within the wound bed and covered the previously exposed muscle and tendon. The donor site, which was closed primarily at the time of harvest, was also completely healed.

Acute Wound

Chronic Wound

Initial Wound: Following a traumatic crush injury, the patient was left with a refractory wound over his left lateral foot. SkinTE was deployed into this defect in the provider’s office.

Mid-Stage Healing of SkinTE: Six months following the application of SkinTE in the office, the patient experienced full-thickness, functional skin regeneration within the wound bed and the previously exposed bone was covered. The donor site, which was closed primarily at the time of harvest, was also completely healed.

Post-Mohs Reconstruction

Diabetic Foot Ulcer (DFU)

Initial Wound: Following Mohs surgical excision, the patient was left with a full-thickness skin defect with exposed muscle over her philtrum. Due to her history of complications with traditional local flap reconstruction, the patient elected to utilize SkinTE.

Initial Wound: The patient had a full-thickness, persistent DFU over his left foot with exposed bone. The patient’s wound failed conservative measure of treatment and, with the presence of exposed bone, presented a risk of underlying infection of the bone and made conventional treatment with skin grafting problematic. The provider elected to utilize SkinTE in the office.

Early-Stage Healing: One month following SkinTE deployment (done in the office), the patient experienced full-thickness skin regeneration over her exposed muscle with full three-dimensional contour restored without distorting the critical anatomical landmarks of the face. The donor site, which was closed primarily at the time of harvest, also healed completely.

Mid-Stage Healing: Four months following SkinTE deployment in the office, the patient experienced full-thickness skin regeneration over his exposed bone. The donor site, which was closed primarily at the time of harvest, also healed completely.

Acute Traumatic Wound

Mid-Stage Healing of SkinTE: Three months following the single application of SkinTE, SkinTE regenerated full-thickness functional skin within the wound bed and covered the previously exposed muscle, bone and tendon. The patient experienced limited donor site morbidity. The range of motion of her foot remained intact.

Initial Wound: Following a lawnmower injury, the patient was left with a wound on her right heel with exposed muscle, tendon and bone. SkinTE was deployed into this defect.

STSG Replacement

Traumatic Injury

Mid-Stage Healing of SkinTE: Five months following the single deployment of SkinTE, SkinTE had generated full-thickness, hair-bearing skin within the fibrotic wound.

Mid-Stage Healing of SkinTE: Four months following a single application of SkinTE, SkinTE regenerated full-thickness functional skin within the wound bed and covered the previously exposed joint, bone, muscle and tendon. The patient experienced limited donor site morbidity. The range of motion of his foot remained intact.

Initial Wound: Following excision of the fibrotic skin graft, the patient was left with a large defect over the left chest with exposed pectoral within a scarred wound bed. SkinTE was deployed into this defect.

Initial Wound: Following a motor vehicle collision, the patient was left with a full-thickness wound on his left foot with exposed joint, bone, muscle and tendon. SkinTE was deployed into this defect.

Initial Wound: 2-year-old female who suffered acute scald burns to both arms, legs and chest presented to the Burn Unit.

Early-Stage Healing: One month following the acute scald burns, full-thickness skin regeneration is seen over areas that failed initial treatment with split-thickness skin grafts.

Burn


Notes

FOR MEDICAL PROVIDERS | www.PolarityTE.com | PTE.Cool/SkinTE

SkinTE is a human cellular and tissue-based product derived from a patient’s own skin to regenerate full-thickness, functionally-polarized skin with all of its layers (epidermis, dermis and hypodermis) and appendages, including hair follicles and glands.

For the Autologous Homologous Treatment of Skin Tissue1

• Wounds (acute & chronic)• Surgical reconstruction events• Burns (acute, subacute & burn

reconstruction)

• Scar revision• Traumatic injuries• Replacement of skin grafts

or failed fl ap coverage

For the Repair, Reconstruction & Replacement of Full-Thickness Skin

1. Conditions treated with SkinTE

Where Self Regenerates Self®

®

Part No. STE-CPG-100; Rev No. 01

Coding & Payment GuidePolarityTE Customer Service:Tel: 1-800-560-3383

PolarityTE Reimbursement Hotline:Tel: 1-800-284-0262Email: [email protected]

2 © 2019 PolarityTE, Inc. All rights reserved. All trademarks used herein are trademarks of their respective owners.

1. Current Procedural Terminology (CPT) is a registered trademark of the American Medical Association (AMA). Copyright 2017 AMA. All rights reserved.2. The Medicare National Facility and Non-Facility Provider payments and RVUs provided in the table above are national averages and are to be used as reference only.3. APC – Ambulatory Payment Classifi cation4. The Medicare National Average Rates provided in the table above are approximate and are to be used as reference only.

PHYSICIAN FACILITY


Physician Non-Facility2 APC3

APC National Medicare Payment4


Cultured Autograft

15040 Harvest skin for tissue cultured autograft, 100 cm2 or less 2.00 $130.46 $262.73 5054 $1,548.96 $797.53

15150 Tissue cultured skin autograft, trunk, arms, legs; 25 cm2 or less 9.39 $660.24 $722.58 5054 $1,548.96 $797.53

+15151 Additional 1 cm2 to 75 cm2 2.00 $114.96 $124.33 N/A — —

+15152Additional 100 cm2, or each additional 1% BSA of infants and children, or part thereof

2.50 $143.44 $153.17 N/A — —

15155Tissue cultured skin autograft, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet and/or multiple digits; fi rst 25 cm2 or less

10.14 $758.62 $823.13 5055 $2,766.13 $1,424.22

+15156 Additional 1 cm2 to 75 cm2 2.75 $157.85 $167.58 N/A — —

+15157Each additional 100 cm2 or each additional 1% BSA of infants and children

3.00 $172.27 $186.32 N/A — —


15100Split-thickness autograft, trunk, arms, legs; fi rst 100 cm2 or less, or 1% BSA of infants and children

9.90 $739.88 $85.84 5054 $1,548.96 $797.53

+15101Each additional 100 cm2, or each one percent BSA of infants and children, or part thereof

1.72 $116.05 $191.37 N/A — —

15120Split-thickness autograft, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet and/or multiple digits; fi rst 100 cm2 or less, or 1% BSA of infants and children

10.15 $721.14 $875.39 5055 $2,766.13 $1,424.22

+15121Each additional 100 cm2, or each 1% BSA of infants and children, or part thereof

2.00 $139.11 $214.43 N/A — —


15200Full-thickness graft, free, including direct closure of donor site, trunk; 20 cm2 or less

9.15 $697.00 $858.81 5054 $1,548.96 $797.53

+15201Each additional 20 cm2 (list separately in addition to code for primary procedure)

1.32 $81.45 $149.20 N/A — —

15220Full-thickness graft, free, including direct closure of donor site, scalp, arms and/or legs; 20 cm2 or less

8.09 $636.81 $795.02 5054 $1,548.96 $797.53


1.19 $73.88 $139.47 N/A — —


10.41 $829.26 $961.52 5054 $1,548.96 $797.53


1.86 $114.60 $188.12 N/A — —

15260Full-thickness graft, free, including direct closure of donor site, nose, ears, eyelids and/or lips; 20 cm2 or less

11.64 $888.36 $1,040.81 5054 $1,548.96 $797.53


2.23 $144.52 $218.04 N/A — —

Continued

2019 Coding & Payment Guide

REIMBURSEMENT DISCLAIMER: PolarityTE provides this coding guide for informational purposes only and it is subject to change without notice. This guide is not an affi rmative instruction as to which codes and modifi ers to use for a particular service, supply, procedure or treatment and does not constitute advice regarding coding, coverage, or payment for PolarityTE products. It is the responsibility of providers, physicians and suppliers to determine and submit appropriate codes, charges and modifi ers for products, services, supplies, procedures, or treatment furnished or rendered. Providers, physicians and suppliers should contact their payers for specifi c and current information on their coding, coverage, and payment policies. For further detailed product information, including indications for use, contraindications, eff ects, precautions and warnings, please consult the product’s Instructions for Use (IFU) prior to use. The information provided herein is without any other warranty or guarantee of any kind, expressed or implied, as to completeness, accuracy, or otherwise. This information is intended only to help estimate payment rates and product costs in each clinical setting. All rates shown are national average Medicare rates, have not been adjusted for geographic variations in payment or other factors, such as sequestration, and are subject to change without notice.

18




PHYSICIAN FACILITY





Outpatient Facility Payments for Skin Substitute

C5271Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 cm2; fi rst 25 cm2 or less wound surface area

5053 $482.89 $248.63

+C5272Each additional 25 cm2 wound surface area, or part thereof (list separately in addition to code for primary procedure)

N/A — —

C5273Application of skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 cm2; fi rst 100 cm2 wound surface area, or 1% BSA of infants and children

5054 $1,548.96 $797.53

+C5274Each additional 100 cm2 wound surface area, or part thereof, or each additional 1% BSA of infants and children, or part thereof (list separately in addition to code for primary procedure)

N/A — —

C5275

Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet and/or multiple digits, total wound surface area up to 100 cm2; fi rst 25 cm2 or less wound surface area

5053 $482.89 $248.63

+C5276Each additional 25 cm2 wound surface area or part thereof (list separately in addition to code for primary procedure)

N/A — —

C5277

Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet and/or multiple digits, total wound surface area greater than or equal to 100 cm2; fi rst 100 cm2 wound surface area, or 1% BSA of infants and children

5053 $482.89 $248.63

+C5278Each additional 100 cm2 wound surface area, or part thereof, or each additional 1% BSA of infants and children or part thereof (list separately in addition to code for primary procedure)

N/A — —

Physician Payments for Skin Substitute

15271Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 cm2; fi rst 25 cm2 or less wound surface area

1.50 $87.21 $149.20

+15272

Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 cm2; each additional 25 cm2 wound surface area or part thereof (list separately in addition to code for primary procedure)

0.33 $18.02 $27.39

15273Application of skin substitute graft to trunk, legs, total wound surface area greater than or equal to 100 cm2; fi rst 100 cm2 wound surface area, or 1% BSA of infants and children

3.50 $210.47 $314.62

+15274

Application of skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 cm2; each additional 100 cm2 wound surface area, or part thereof, or each additional 1% BSA of infants and children, or part thereof (list separately in addition to code for primary procedure)

0.80 $47.93 $77.48

15275

Application of skin substitute graft to face, scalp, eyelids, mouth, neck ears, orbits, genitalia, hands, feet and/or multiple digits, total wound surface area up to 100 cm2; fi rst 25 cm2 or less wound surface area

1.83 $98.75 $157.49

+15276

Application of skin substitute graft to face scalp eyelids, mouth, neck ears, orbits, genitalia, hands, feet and/or multiple digits, total wound surface area up to 100 cm2; each additional 25 cm2 wound surface area, or part thereof (list separately in addition to code for primary procedure)

0.50 $26.31 $35.32

15277

Application of skin substitute graft to face scalp eyelids, mouth, neck ears, orbits, genitalia, hands, feet and/or multiple digits, total wound surface area up to 100 cm2; fi rst 100 cm2 wound surface area, or 1% BSA of infants and children

4.00 $237.86 $344.17

1. Current Procedural Terminology (CPT) is a registered trademark of the American Medical Association (AMA). Copyright 2017 AMA. All rights reserved.2. The Medicare National Facility and Non-Facility Provider payments and RVUs provided in the table above are national averages and are to be used as reference only.3. APC – Ambulatory Payment Classifi cation 4. The Medicare National Average Rates provided in the table above are approximate and are to be used as reference only.

Continued

Not Applicable

Not Applicable

19


PHYSICIAN FACILITY





Physician Payments for Skin Substitute (continued...)

+15278

Application of skin substitute graft to face scalp eyelids, mouth, neck ears, orbits, genitalia, hands, feet and/or multiple digits, total wound surface area up to 100 cm2; each additional 100 cm2 wound surface area, or part thereof, or 1% BSA of infants and children (list in addition to code for primary procedure)

1.00 $59.82 $91.54

Other


— — — 5051 $176.45 —


The above HCPCS code is provided for informational purposes only and may be subject to change without notice. Actual codes used are at the sole discretion of the treating provider and/or facility. PolarityTE does not guarantee medical benefi t coverage or reimbursement with the codes listed in this guide.

1. Current Procedural Terminology (CPT) is a registered trademark of the American Medical Association (AMA). Copyright 2017 AMA. All rights reserved.2. The Medicare National Average Rates provided in the table above are approximate and are to be used as reference only.3. APC – Ambulatory Payment Classifi cation 4. Centers for Medicare and Medicaid Services, 2019 Alpha-Numeric HCPCS File, available at https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Alpha-Numeric-HCPCS.html 5. American Medical Association, 2018 CPT Manual: Appendix A

HCPCS Code4 Description

Q4200 SkinTE, per cm2

Possible Modifi er5 Description

-52 Reduced Services; “service or procedure is partially reduced or eliminated at the discretion of the physician”

-58Staged or Related Procedure or Service by the Same Provider or Other Qualifi ed Health Care Professional During the Postoperative Period; “Performance of a procedure or service during the postoperative period was planned or anticipated (staged)”

The above modifi ers are provided for informational purposes only and may be subject to change without notice. Actual modifi ers used are at the sole discretion of the treating provider and/or facility. PolarityTE does not guarantee medical benefi t coverage or reimbursement with the codes listed in this guide

Not Applicable

20


Hospital Inpatient Diagnosis Related Groupings (DRG)


PossibleMS-DRG MS-DRG Title

Medicare National Average

Rate1

463 Wound debridement and skin graft except hand, for musculo-connective tissue disorders with major complications or comorbidities $28,577.96

464 Wound debridement and skin graft except hand, for musculo-connective tissue disorders with complications or comorbidities $16,394.22

465Wound debridement and skin graft except hand, for musculo-connective tissue disorders without complications or comorbidities or major complications or comorbidities

$10,231.91

573 Skin graft for skin ulcer or cellulitis with major complications or comorbidities $29,243.98

574 Skin graft for skin ulcer or cellulitis with complications or comorbidities $16,961.67

575 Skin graft for skin ulcer or cellulitis without complications or comorbidities or major complications or comorbidities $9,793.10

576 Skin graft except for skin ulcer or cellulitis with major complications or comorbidities $27,179.11

577 Skin graft except for skin ulcer or cellulitis with complications or comorbidities $13,972.96

578 Skin graft except for skin ulcer or cellulitis without complications or comorbidities or major complications or comorbidities $8,518.43

622 Skin grafts and wound debridement for endocrine, nutritional and metabolic diseases with major complications or comorbidities $21,149.88

623 Skin grafts and wound debridement for endocrine, nutritional and metabolic diseases with complications or comorbidities $10,709.70

624Skin grafts and wound debridement for endocrine, nutritional and metabolic diseases without complications or comorbidities or major complications or comorbidities

$7,217.02

904 Skin grafts for injuries with complications or comorbidities or major complications or comorbidities $17,964.59

905 Skin grafts for injuries without complications or comorbidities or major complications or comorbidities $9,852.13

927 Extensive burns or full thickness burns with mechanical ventilation > 96 hours with skin graft $102,377.58

928 Full-thickness burn with skin graft or inhalation injury with complication or comorbidities or major complications or comorbidities $32,719.39

929 Full-thickness burn with skin graft or inhalation injury without complication or comorbidities or major complications or comorbidities $16,551.26

957 Other operating room procedures for multiple signifi cant trauma with major complications or comorbidities $42,313.69

958 Other operating room procedures for multiple signifi cant trauma with complication or comorbidities $23,276.01

959 Other operating room procedures for multiple signifi cant trauma without major complications or comorbidities $13,647.19

1. The Medicare National Average Rates provided in the table above are approximate and are to be used as reference only.




21


PolarityTE Reimbursement Hotline

Tel: 1-800-284-0262 Email: [email protected]

The PolarityTE Reimbursement Hotline is comprised of a specialized team in reimbursement to support providers and customers in multiple ways including provider education on coverage, coding and payment mechanisms for PolarityTE commercial products.

PolarityTE Reimbursement Hotline staff provide assistance with the following:

• General commercial product support

• Coding, coverage and reimbursement education and support

• Prior Authorization Assistance

The PolarityTE Reimbursement Hotline staff is not able to and will not confirm the contracted or reimbursable rates on your behalf.


Notes

24

Inquiries

Customer Service:Tel: 1-800-560-3983Email: [email protected]

Reimbursement Team:Tel: 1-800-284-0262Email: [email protected]

PolarityTE, Inc. 123 North Wright Brothers DriveSalt Lake City, Utah 84116

© 2019 PolarityTE, Inc. All rights reserved. POLARITYTE , the POLARITYTE logo,WHERE SELF REGENERATES SELF and SKINTE are all trademarks or registered trademarks of PolarityTE, Inc. Patents Pending.

All trademarks used herein are trademarks of their respective owners.

mailto:CustomerService%40PolarityTE.com?subject=SkinTE%20IFU

mailto:CustomerService%40PolarityTE.com?subject=SkinTE%20IFU

reimbursement guide 2019 · skinte is fda-registered as a human cells, tissues and cellular and...

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