Grafix Reimbursement Guide

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5Reimbursement Guide

Grafix Reimbursement Hotline: 1-855-947-2349

(855-9GRAFIX) FAX: 1-855-850-3005

Osiris Therapeutics, Inc. Customer Support: 866-352-4540

2015 Reimbursement Guide

Grafix® is a cryopreserved placental allograft tissue for acute and chronic wounds. Grafix is regulated as a

human cells, tissue, or a cellular or tissue-based product (HCT/P) under 21 CFR part 1271 and section 361 of

the Public Health Service (PHS) Act. Osiris Therapeutics, Inc. is registered with the FDA as a tissue establish-

ment and accredited by the American Association of Tissue Banks (AATB).

Description

Three-dimensional matrix designed for application directly to acute and chronic wounds, including but not

limited to: diabetic foot ulcers, venous leg ulcers, pressure ulcers, and burns.

Cryopreserved placental membranes have been shown to be beneficial in supporting natural wound repair

in the following ways1:

• Serves as a barrier from the environment and thus protects the tissue from infection

• Reduces inflammation

• Reduces scarring by supporting wound closure without excessive fibrosis

Grafix is an alternative to autologous skin grafting that eliminates the pain, co-morbidities, and procedure

time associated with obtaining autologous grafts.

Clinical Data

Grafix has been studied in a multi-center (n=20), randomized, controlled clinical trial, Protocol 302, which

demonstrated overwhelming efficacy of Grafix compared to the control (standard of care included surgical

debridement, off-loading, and non-adherent dressings) in the closure of diabetic foot ulcers over 12 weeks

(62% vs. 21.3%, p=0.0001, n=97).2

A retrospective study of the use of Grafix in chronic refractory wounds included diabetic foot ulcers, venous

leg ulcers, and pressure ulcers. This study included a total of 66 patients with 67 wounds. Average time to

closure in these wounds was 5.8 weeks. More than 75% of wounds were closed after 12 weeks of care after

previously being treated unsuccessfully for an average of 38 weeks. Additionally, 75% of these patients had

failed other wound therapies prior to Grafix and 50% had failed two previous wound therapies.3

The information provided in this manual is not a guarantee of coverage or payment. Documentation should always reflect the actual services completed. Please refer to the patient’s insurance plan and/or the local Medicare Administrative Contractor for Local Coverage Determinations (LCDs) and for additional information and guidance on coding, coverage, and payment.

References: 1. Niknejad H, Peirovi H, Jorjani M, Ahmadiani A, Ghanavi J, Seifalian A. Properties of the amniotic membrane for potential use in tissue engineering. Eur Cell Mater. 2008;15:88-99. 2. Lavery LA, Fulmer J, Shebetka KA, Regulski M, Vayser D, Fried D, et al. The efficacy and safety of Grafix for the treatment of chronic diabetic foot ulcers: results of a multi-centre, controlled, randomised, blinded, clinical trial. Int Wound J. 2014;11(5):554-560. doi:10.1111/iwj.12329. Published online July 21, 2014. 3. Regulski M, Jacobstein DA, Petranto RD, Migliori VJ, Nair G, Pfeiffer D. A retrospective analysis of a human cellular repair matrix for the treatment of chronic wounds. Ostomy Wound Manage. 2013;59(12):38-43.

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Grafix® Product HCPCS Codes

Product Code Billable Units

Grafix®PRIME

14 mm Disc Q4133 2

Grafix®PRIME 1.5 x 2 cm

Q4133 3

Grafix®PRIME 2 x 3 cm

Q4133 6


Q4133 12


Q4133 16


Q4133 25

Grafix®CORE 1.5 x 2 cm

Q4132 3

Grafix®CORE 2 x 3 cm

Q4132 6


Q4132 12


Q4132 16


Q4132 25

HCPCS stands for Healthcare Common Procedure Coding System (HCPCS). For Medicare and other health insurance programs to ensure health care claims are processed in an orderly and consistent manner, standardized coding systems are essential. The HCPCS Level II code set is one of the standard code sets used by medical coders and billers for this purpose. The other, HCPCS Level I coding set, is comprised of CPT® (Current Procedural Terminology), copyrighted by the American Medical Association (AMA).

The HCPCS codes are supplied for informational purposes only and do not represent a statement, promise, or guarantee by Osiris that these codes will be appropriate or that reimbursement will be made. Coding practice will vary by site of care, patient condition, range of service provided, local payer instructions, and other factors. The decision as to how to complete a reimbursement form, including amount to bill, is exclusively the responsibility of the provider. The provider is ultimately responsible for verifying coverage with the patient’s payer source.


ICD-9-CM Description

707.10 Unspecified ulcer of lower limb

707.11 Ulcer of thigh

707.12 Ulcer of calf

707.13 Ulcer of ankle

707.14 Ulcer of the heel and midfoot

707.15 Ulcer of other part of foot

707.19 Ulcer of other part of lower limb


249.60 Secondary diabetes mellitus with neurological manifestations, not stated as uncontrolled, or unspecified

249.61 Secondary diabetes mellitus with neurological manifestations, uncontrolled

249.70 Secondary diabetes mellitus with peripheral circulatory disorders, not stated as uncontrolled, or unspecified

249.71 Secondary diabetes mellitus with peripheral circulatory disorders, uncontrolled

249.80 Secondary diabetes mellitus with other specified manifestations, not stated as uncontrolled, or unspecified

249.81 Secondary diabetes mellitus with other specified manifestations, uncontrolled

250.60 Diabetes with neurological manifestations, type II or unspecified type, not stated as uncontrolled

250.61 Diabetes with neurological manifestations, type I (Juvenile type), not stated as uncontrolled

250.62 Diabetes with neurological manifestations, Type II or unspecified type, uncontrolled

250.63 Diabetes with neurological manifestations, Type I [Juvenile type], uncontrolled

250.70 Diabetes with peripheral circulatory disorders, Type II or unspecified type, not stated as uncontrolled

250.71 Diabetes with peripheral circulatory disorders, Type I (Juvenile type), not stated as uncontrolled

250.72 Diabetes with peripheral circulatory disorders, Type II or unspecified type, uncontrolled

250.73 Diabetes with peripheral circulatory disorders, Type I (Juvenile type], uncontrolled

250.80 Diabetes with other specified manifestations, Type II or unspecified type, not stated as uncontrolled

250.81 Diabetes with other specified manifestations, Type I (Juvenile type], not stated as uncontrolled

250.82 Diabetes with other specified manifestations, Type II or unspecified type, uncontrolled

250.83 Diabetes with other specified manifestations, Type I (Juvenile type], uncontrolled

ICD-9 Diagnosis Codes*

Please check with your local payers or Medicare Administrative Contractor for specific coding and billing

requirements. The following represents ICD-9-CM codes that can be utilized with skin substitutes. The

following ICD-9-CM codes must be used in pairs, i.e., one primary diagnosis and one secondary diagnosis.

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*Always refer to the insurer-specific coverage policy or contact the insurer for instructions. The ICD-9 and HCPCS codes are supplied for informational purposes only and do not represent a statement, promise, or guarantee by Osiris that these codes will be appropriate or that reimbursement will be made. Coding practice will vary by site of care, patient condition, range of service provided, local payer instructions, and other factors. The decision as to how to complete a reimbursement form, including amount to bill, is exclusively the responsibility of the provider. The provider is ultimately responsibility for verifying coverage with the patient’s payer source.

ICD-9-Diagnosis Codes* Venous Ulcer Codes

Please check with your local payers or Medicare Administrative Contractor for specific coding and billing

requirements. The following represents ICD-9-CM codes that can be utilized with skin substitutes. The following

ICD-9-CM codes must be used in pairs, i.e., one primary diagnosis and one secondary diagnosis.

707.10 Unspecified ulcer of lower limb

707.11 Ulcer of thigh

707.12 Ulcer of calf


707.14 Ulcer of heel and midfoot

707.15 Ulcer of other part of foot

707.19 Ulcer of other part of lower limb


454.0 Varicose veins of lower extremities with ulcer

454.2 Varicose veins of lower extremities with ulcer and inflammation

459.11 Postphlebetic syndrome with ulcer


459.31 Chronic venous hypertension with ulcer

459.33 Chronic venous hypertension with ulcer and inflammation

459.81 Venous (peripheral) insufficiency, unspecified



CPT Code Descriptor

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

+ 15272 Each additional 25 sq cm up to 100 sq cm wound surface area, or part thereof (list separately in addition to code for primary procedure)

15273 Application of skin substitute graft to trunk, arms, legs, total wound surface are greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children

+ 15274 Each additional 100 sq cm wound surface area or part thereof, or each additional 1% of body area of infants and children or part thereof (list separately in addition to code for primary procedure)

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 sq cm; first 25 sq cm or less wound surface area

+ 15276 Each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure)

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 greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children

15278 Each additional 100 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure)

†CPT® codes are a registered trademark of the American Medical Association®.The CPT codes supplied above are for informational purposes only and do not represent a statement, promise, or guarantee that these codes will be appropriate or that reimbursement will be made. Coding practice will vary by site of care, patient condition, range of service provided, local payer instructions, and other factors. The decision as to how to complete a reimbursement form, including codes used and amount to bill, is exclusively the responsibility of the provider.

CPT®† Coding

The CPT code set describes medical, surgical, and diagnostic services and is designed to communicate

uniform information about medical services and procedures among physicians, coders, patients,

accreditation organizations, and payers for administrative, financial, and analytical purposes.

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2015 Medicare

Hospital Outpatient Department and Hospital-Affiliated ASC

Effective January 1st, 2015, the Centers for Medicare & Medicaid Services (CMS) assigned Grafix®CORE

and Grafix®PRIME to the high bundle for Medicare-only patients. Customers will continue to bill the 1527X

series for the application of Grafix. The rates below are 100% of the Medicare allowable; Medicare pays

80%, the patient or secondary/supplemental plan will be responsible for the remaining 20%.

IMPORTANT: Medicare does not separately reimburse for the majority of skin substitute products,

including Grafix. Therefore, when Grafix is applied in the hospital outpatient setting, Medicare reimburses

the CPT® code payment amount listed below only; there is no separate reimbursement for Grafix.

Hospital Outpatient

Both Grafix Core and Prime are included in the high bundle4-6

CMS Payment Information is available from the following sources: 4 Hospital Outpatient/Hospital-affiliated ASC: http://federalregister.gov/a/2014-26146

Skin Substitute discussion begins on page 4435 CMS Physician Services Fee Schedule: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/

PFS-Federal-Regulation-Notices-Items/CMS-1612-FC.html6 CMS Hospital Outpatient Prospective Payment System (PPS): https://www.federalregister.gov/regulations/0938-AS15/

cy-2015-hospital-outpatient-prospective-payment-system-pps-policy-changes-and-payment-rates-and-cy-2

CPT High Bundle Rates

15271, 15275, 15277 $ 1406.87

15273 $ 2300.64

Hospital-Affiliated ASC

CPT High Bundle Rates

15271, 15275, 15277 $ 771.43

15273 $ 1261.51


Physician Services

Grafix® is not included on the Part B Average Sales Price (ASP) list published by the CMS at this time.

Therefore, Grafix is instead paid at invoice cost.7-9

IMPORTANT BILLING INSTRUCTIONS: Please note, customers should not actually submit the hard

copy invoice to the contractor. Box 19 on the CMS-1500 claim form allows the provider to include the

invoice cost and product details, including name and size. Payment based on invoice cost does not

delay the electronic processing of claims.

CMS Payment Information is available from the following sources: 7 Hospital Outpatient/Hospital-affiliated ASC: http://federalregister.gov/a/2014-26146 Skin Substitute discussion begins on page

443.8 CMS Physician Services Fee Schedule: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/

PFS-Federal-Regulation-Notices-Items/CMS-1612-FC.html9 CMS Hospital Outpatient Prospective Payment System (PPS): https://www.federalregister.gov/regulations/0938-AS15/

cy-2015-hospital-outpatient-prospective-payment-system-pps-policy-changes-and-payment-rates-and-cy-2

2015 Medicare

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BILLING REMINDERS

Note: Grafix® Reimbursement Hotline staff are available to assist with coding, coverage, and

reimbursement questions.

Grafix Reimbursement Hotline

1-855-947-2349 (855-9GRAFIX) FAX: 1-855-850-3005

Units Billed

Check units billed – due to cross contaminations issues, payers generally reimburse for the entire square-

centimeter piece, as it is often reasonable and necessary to discard a portion of the product.

Product Wastage Documentation Requirements

Any amount of wasted material should be clearly documented in the medical record with the following information:

• Date, time, and location of ulcer treated

• Approximate amount of product unit used

• Approximate amount of product unit discarded

• Reason for the wastage

• Manufacturer’s serial/lot/batch or other unit identification number of graft material

Modifiers

Check to see if modifiers are required with HCPCS Q4132/Q4133 and/or CPT codes used.

Common modifiers include:

- JC: skin substitute used as a graft

- JW: wastage

- KX: requirements in the medical policy have been met

Wound Size

Determining the wound location and surface area is important in order to select the appropriate CPT code.

Please reference the CPT descriptions.

Debridement:

Debridement is considered a component code of skin substitute CPT application codes and is not typically

separately reimbursed. Many insurers have specific guidelines on debridement services. Check with the

insurer on insurer-specific guidance.

Diagnosis Code(s) Order

Check with the insurer to ensure diagnoses are in the proper primary and secondary order on claims forms.

Commercial Insurers and Contracted Rates Check your facility’s specific payer contracts prior to applying Grafix.

IMPORTANT: Many insurers consider contracted rates to be proprietary information and they do not

release this information upon verifying benefits. However, insurers may release a general fee schedule rate.

Your practice or facility’s contract may not necessarily reimburse that rate. We recommend verifying your

contracted rates by either accessing your contract or contacting your provider relations representative.


Medical Necessity/Documentation

How do I determine if Grafix® is considered reasonable and necessary for my patient’s condition?

It is recommended that the provider review clinical evidence for Grafix with respect to appropriate

diagnoses, application, frequency, etc. If there is an applicable LCD or medical policy for Grafix, all

requirements and guidelines must be met in order for the patient to be covered.

Reasonable and Necessary

• Safe

• In accordance with generally accepted standards of medical practice

• Clinically appropriate in terms of type, frequency, extent, site, and duration

• Ordered and furnished by qualified personnel

Suggested Documentation Requirements based on current wound care standards:

• Duration of wound

• Type(s) of conservative treatment that failed to induce significant healing

• Exact location of wound

• Baseline measurements immediately prior to initiation of treatment

• Wound is free of infection and osteomyelitis

• Adequate treatment of the underlying disease contributing to the wound

• Adequate blood flow

• Measurement of the wound (length and width or circumference and depth)

• Application number and improvement since last treatment

• Amount of Grafix used and amount discarded (wastage)

• Physician’s choice of fixation

• Appropriate wound dressing changes, patient compliance, and off-loading (if applicable)

The information provided above is not a guarantee of coverage or payment. Documentation should always reflect the actual services completed. Please refer to the patient’s insurance plan and/or the local Medicare Administrative Contractor (MAC) LCD for additional information regarding documentation.

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Sample Letter of Medical Necessity

“Sample Letter of Medical Necessity”(Please Type on Physician’s Letterhead)

DateInsurer NameInsurer AddressCity, State, Zip Code

Re: Letter of Medical Necessity for Grafix®

Patient’s NamePolicy NumberGroup NumberDate of Birth

Dear [Insurance contact name]:

I am writing to notify you of my intent to treat Mr. / Ms. <Patient’s Name> with Grafix which is a biological skin substitute used to treat <name of type of wound: i.e. pressure wounds/diabetic foot ulcers/venous stasis ulcers, etc.>. The patient’s medical history is as follows:

Grafix is an allograft tissue matrix regulated by the FDA under 21 CFR Part 1271 Human Cells, Tissue, and Cellular and Tissue-based Products (HCT/Ps), and section 361 of the Public Health Service Act (PHS Act). Osiris Therapeutics, Inc is registered with the FDA as a tissue establishment and is ac-credited by the American Association of Tissue Banks (AATB).

Grafix is a cryopreserved placental membrane retaining the extracellular matrix, growth factors, and endogenous neonatal stem cells, fibroblasts, and epithelial cells of the native tissue. Grafix, as a pla-cental matrix, can support migration, proliferation, and differentiation of several types of cells in the patient (i.e recipient) known to be involved in the body’s natural repair process.

My patient has not responded to conservative care for <time frame> and has not responded to more advanced therapy including <product name(s) &type(s) of products>. More aggressive treatment is medically necessary to prevent further damage and <list risk(s) of non-closure>. I believe my patient will benefit from this therapy.

Please feel free to contact me if additional information is required to process my request for coverage.

Sincerely,

Some payers may require a healthcare provider to provide a letter of medical necessity to obtain

prior authorization or to accompany a claim to justify payment. When providing such a letter, the

provider should include information in the letter of medical necessity that supports the decision to

apply Grafix®PRIME or Grafix®CORE to the patient. The letter should include information on the severity of

the wound, previous medications and treatments tried and their outcome, impact upon the patient’s

quality of life, and the provider’s past clinical experience with the product. Below is a sample letter of

medical necessity for the application of Grafix®PRIME. This is a sample only and should be modified as

necessary to be accurate and to fit each patient’s specific situation.


This example represents the procedure conducted in the hospital or hospital-affiliated ASC and

the hospital/ASC is billing for facility services and Grafix®.

HOPD or Hospital-Affiliated ASC:

Free-Standing ASC would use the CMS-1500 form for billing purposesBox 42 Revenue CodeBox 43 Product and Application description (Grafix and application) Box 44 HCPCS Codes (Grafix and application code)Box 45 Date of ServiceBox 46 Number of Units; Grafix and application CodeBox 47 Total Charges for Grafix and application Code

__ __ __

1 2 4 TYPEOF BILL

FROM THROUGH5 FED. TAX NO.

abc

d

DX

ECI

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

1

2

3

4

5

6

7

8

9

10

11

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13

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15

16

17

18

19

20

21

22

23

A

B

C

A B C D E F G HI J K L M N O P Q

a b c a b c

a

b c d

ADMISSION CONDITION CODESDATE

OCCURRENCE OCCURRENCE OCCURRENCE OCCURRENCE SPAN OCCURRENCE SPANCODE DATE CODE CODE CODE DATE CODE THROUGH

VALUE CODES VALUE CODES VALUE CODESCODE AMOUNT CODE AMOUNT CODE AMOUNT

TOTALS

PRINCIPAL PROCEDURE a. OTHER PROCEDURE b. OTHER PROCEDURE NPICODE DATE CODE DATE CODE DATE

FIRST

c. d. e. OTHER PROCEDURE NPICODE DATE DATE

FIRST

NPI

b LAST FIRST

c NPI

d LAST FIRSTUB-04 CMS-1450

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10 BIRTHDATE 11 SEX 12 13 HR 14 TYPE 15 SRC

DATE

16 DHR 18 19 20

FROM

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CODE FROM

DATE

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THE CERTIFICATIONS ON THE REVERSE APPLY TO THIS BILL AND ARE MADE A PART HEREOF.

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BEN.

CODEOTHER PROCEDURE

THROUGH

29 ACDT 30

3231 33 34 35 36 37

38 39 40 41

42 REV. CD. 43 DESCRIPTION 45 SERV. DATE 46 SERV. UNITS 47 TOTAL CHARGES 48 NON-COVERED CHARGES 49

52 REL51 HEALTH PLAN ID 53 ASG. 54 PRIOR PAYMENTS 55 EST. AMOUNT DUE 56 NPI

57

58 INSURED’S NAME 59 P.REL 60 INSURED’S UNIQUE ID 61 GROUP NAME 62 INSURANCE GROUP NO.

64 DOCUMENT CONTROL NUMBER 65 EMPLOYER NAME

66 67 68

69 ADMIT 70 PATIENT 72 73

74 75 76 ATTENDING

80 REMARKS

OTHER PROCEDURE

a

77 OPERATING

78 OTHER

79 OTHER

81CC

CREATION DATE

3a PAT.CNTL #

24

b. MED.REC. #

44 HCPCS / RATE / HIPPS CODE

PAGE OF

APPROVED OMB NO. 0938-0997

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a8 PATIENT NAME

50 PAYER NAME

63 TREATMENT AUTHORIZATION CODES

6 STATEMENT COVERS PERIOD

9 PATIENT ADDRESS

17 STAT STATE

DX REASON DX 71 PPS

CODE

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636 Gra�x Core Q4132 25 XXX

761 Application 15275 1 XXX

250.XX 707.14

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1a. INSURED’S I.D. NUMBER (For Program in Item 1)

4. INSURED’S NAME (Last Name, First Name, Middle Initial)

7. INSURED’S ADDRESS (No., Street)

CITY STATE

ZIP CODE TELEPHONE (Include Area Code)

11. INSURED’S POLICY GROUP OR FECA NUMBER

a. INSURED’S DATE OF BIRTH

b. EMPLOYER’S NAME OR SCHOOL NAME

d. IS THERE ANOTHER HEALTH BENEFIT PLAN?

13. INSURED’S OR AUTHORIZED PERSON’S SIGNATURE I authorizepayment of medical benefits to the undersigned physician or supplier forservices described below.

SEX

F

OTHER1. MEDICARE MEDICAID TRICARE CHAMPVA

12. PATIENT’S OR AUTHORIZED PERSON’S SIGNATURE I authorize the release of any medical or other information necessaryto process this claim. I also request payment of government benefits either to myself or to the party who accepts assignmentbelow.

SIGNED DATE

ILLNESS (First symptom) ORINJURY (Accident) ORPREGNANCY(LMP)

MM DD YY15. IF PATIENT HAS HAD SAME OR SIMILAR ILLNESS.

GIVE FIRST DATE MM DD YY14. DATE OF CURRENT:

19. RESERVED FOR LOCAL USE

21. DIAGNOSIS OR NATURE OF ILLNESS OR INJURY (Relate Items 1, 2, 3 or 4 to Item 24E by Line)

FromMM DD YY

ToMM DD YY

1

2

3

4

5

625. FEDERAL TAX I.D. NUMBER SSN EIN 26. PATIENT’S ACCOUNT NO. 27. ACCEPT ASSIGNMENT?

(For govt. claims, see back)

31. SIGNATURE OF PHYSICIAN OR SUPPLIERINCLUDING DEGREES OR CREDENTIALS(I certify that the statements on the reverseapply to this bill and are made a part thereof.)

SIGNED DATE

SIGNED

MM DD YY

FROM TO

FROM TO

MM DD YY MM DD YY

MM DD YY MM DD YY

CODE ORIGINAL REF. NO.

$ CHARGES

28. TOTAL CHARGE 29. AMOUNT PAID 30. BALANCE DUE

$ $ $

PICA PICA

2. PATIENT’S NAME (Last Name, First Name, Middle Initial)

5. PATIENT’S ADDRESS (No., Street)

CITY STATE


9. OTHER INSURED’S NAME (Last Name, First Name, Middle Initial)

a. OTHER INSURED’S POLICY OR GROUP NUMBER

b. OTHER INSURED’S DATE OF BIRTH

c. EMPLOYER’S NAME OR SCHOOL NAME

d. INSURANCE PLAN NAME OR PROGRAM NAME

YES NO

( )

If yes, return to and complete item 9 a-d.

16. DATES PATIENT UNABLE TO WORK IN CURRENT OCCUPATION

18. HOSPITALIZATION DATES RELATED TO CURRENT SERVICES

20. OUTSIDE LAB? $ CHARGES

22. MEDICAID RESUBMISSION

23. PRIOR AUTHORIZATION NUMBER

MM DD YY

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YES NO

YES NO

1. 3.

2. 4.

DATE(S) OF SERVICEPLACE OFSERVICE

PROCEDURES, SERVICES, OR SUPPLIES(Explain Unusual Circumstances)

CPT/HCPCS MODIFIER

DIAGNOSISPOINTER

FM

SEXMM DD YY

YES NO

YES NO

YES NO

PLACE (State)

GROUPHEALTH PLAN

FECABLK LUNG

Single Married Other

3. PATIENT’S BIRTH DATE

6. PATIENT RELATIONSHIP TO INSURED

8. PATIENT STATUS

10. IS PATIENT’S CONDITION RELATED TO:

a. EMPLOYMENT? (Current or Previous)

b. AUTO ACCIDENT?

c. OTHER ACCIDENT?

10d. RESERVED FOR LOCAL USE

Employed Student Student

Self Spouse Child Other

(Medicare #) (Medicaid #) (Sponsor’s SSN) (Member ID#) (SSN or ID) (SSN) (ID)

( )

M

SEX

DAYSOR

UNITS

F. H. I. J.24. A. B. C. D. E.

PROVIDER ID. #

17. NAME OF REFERRING PROVIDER OR OTHER SOURCE 17a.

EMGRENDERING

32. SERVICE FACILITY LOCATION INFORMATION 33. BILLING PROVIDER INFO & PH #

NUCC Instruction Manual available at: www.nucc.org

c. INSURANCE PLAN NAME OR PROGRAM NAME

Full-Time Part-Time

17b. NPI

a. b. a. b.

NPI

NPI

NPI

NPI

NPI

NPI

APPROVED BY NATIONAL UNIFORM CLAIM COMMITTEE 08/05

G.EPSDTFamilyPlan

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NPI NPI

CHAMPUS

( )

APPROVED OMB-0938-0999 FORM CMS-1500 (08/05)

Physician Services in Hospital Outpatient Department/ Hospital-affiliated ASC:

This example represents the physician performing the Grafix procedure in the hospital outpatient

department or hospital-affiliated ASC setting and is billing for the physician’s services component.

Example of physician submission for reimbursement when procedure is performed in an HOPD or ASC:Box 19 Designate Grafix Prime/Core Box 21 Diagnosis: Refer to insurer policy for appropriate codes and primary and secondary orderColumn B Place of Service: Refers to where the procedure was performed, Physician Office (11), HOPD (22), or ASC (24)Column D: Use appropriate CPT for application 15275 first 25 sq cm. Use add on 15276 for each additional 25 sq cm

Check policy for appropriate use of modifier. Modifier JC is indicated for Skin Substitute Used as Graft.

Column E Diagnosis: Refer to insurer’s policy for appropriate codes and primary and secondary listing orderColumn G Units: Application units


Physician Services in Physician Office or Non-Hospital Affiliated ASC:

Example of physician submission for reimbursement when procedure is performed within

Physician Office

Box 19 Designate Grafix Prime/Core Box 21 Diagnosis: Refer to insurer policy for appropriate codes and primary and secondary orderColumn B Place of Service: Refers to the location of the procedure, i.e. Physician Office (11), HOPD (22), or ASC (24)Column D: Use appropriate CPT for application 15275 first 25 sq cm. Use add on 15276 for each additional 25 sq cm

Check policy for appropriate use of modifier. Modifier JC is indicated for Skin Substitute Used as Graft.

Column E Diagnosis: Refer to insurer’s policy for appropriate codes and primary and secondary listing orderColumn G Units: Grafix total sq cm/units

1a. INSURED’S I.D. NUMBER (For Program in Item 1)

4. INSURED’S NAME (Last Name, First Name, Middle Initial)

7. INSURED’S ADDRESS (No., Street)

CITY STATE


11. INSURED’S POLICY GROUP OR FECA NUMBER

a. INSURED’S DATE OF BIRTH

b. EMPLOYER’S NAME OR SCHOOL NAME

d. IS THERE ANOTHER HEALTH BENEFIT PLAN?

13. INSURED’S OR AUTHORIZED PERSON’S SIGNATURE I authorizepayment of medical benefits to the undersigned physician or supplier forservices described below.

SEX

F

OTHER1. MEDICARE MEDICAID TRICARE CHAMPVA

12. PATIENT’S OR AUTHORIZED PERSON’S SIGNATURE I authorize the release of any medical or other information necessaryto process this claim. I also request payment of government benefits either to myself or to the party who accepts assignmentbelow.

SIGNED DATE

ILLNESS (First symptom) ORINJURY (Accident) ORPREGNANCY(LMP)

MM DD YY15. IF PATIENT HAS HAD SAME OR SIMILAR ILLNESS.

GIVE FIRST DATE MM DD YY14. DATE OF CURRENT:

19. RESERVED FOR LOCAL USE

21. DIAGNOSIS OR NATURE OF ILLNESS OR INJURY (Relate Items 1, 2, 3 or 4 to Item 24E by Line)

FromMM DD YY

ToMM DD YY

1

2

3

4

5

625. FEDERAL TAX I.D. NUMBER SSN EIN 26. PATIENT’S ACCOUNT NO. 27. ACCEPT ASSIGNMENT?

(For govt. claims, see back)

31. SIGNATURE OF PHYSICIAN OR SUPPLIERINCLUDING DEGREES OR CREDENTIALS(I certify that the statements on the reverseapply to this bill and are made a part thereof.)

SIGNED DATE

SIGNED

MM DD YY

FROM TO

FROM TO

MM DD YY MM DD YY

MM DD YY MM DD YY

CODE ORIGINAL REF. NO.

$ CHARGES

28. TOTAL CHARGE 29. AMOUNT PAID 30. BALANCE DUE

$ $ $

PICA PICA

2. PATIENT’S NAME (Last Name, First Name, Middle Initial)

5. PATIENT’S ADDRESS (No., Street)

CITY STATE


9. OTHER INSURED’S NAME (Last Name, First Name, Middle Initial)

a. OTHER INSURED’S POLICY OR GROUP NUMBER

b. OTHER INSURED’S DATE OF BIRTH

c. EMPLOYER’S NAME OR SCHOOL NAME

d. INSURANCE PLAN NAME OR PROGRAM NAME

YES NO

( )

If yes, return to and complete item 9 a-d.

16. DATES PATIENT UNABLE TO WORK IN CURRENT OCCUPATION

18. HOSPITALIZATION DATES RELATED TO CURRENT SERVICES

20. OUTSIDE LAB? $ CHARGES

22. MEDICAID RESUBMISSION

23. PRIOR AUTHORIZATION NUMBER

MM DD YY

CA

RR

IER

PA

TIE

NT

AN

D IN

SU

RE

D IN

FO

RM

AT

ION

PH

YS

ICIA

N O

R S

UP

PL

IER

INF

OR

MA

TIO

N

M F

YES NO

YES NO

1. 3.

2. 4.

DATE(S) OF SERVICEPLACE OFSERVICE

PROCEDURES, SERVICES, OR SUPPLIES(Explain Unusual Circumstances)

CPT/HCPCS MODIFIER

DIAGNOSISPOINTER

FM

SEXMM DD YY

YES NO

YES NO

YES NO

PLACE (State)

GROUPHEALTH PLAN

FECABLK LUNG

Single Married Other

3. PATIENT’S BIRTH DATE

6. PATIENT RELATIONSHIP TO INSURED

8. PATIENT STATUS

10. IS PATIENT’S CONDITION RELATED TO:

a. EMPLOYMENT? (Current or Previous)

b. AUTO ACCIDENT?

c. OTHER ACCIDENT?

10d. RESERVED FOR LOCAL USE

Employed Student Student

Self Spouse Child Other

(Medicare #) (Medicaid #) (Sponsor’s SSN) (Member ID#) (SSN or ID) (SSN) (ID)

( )

M

SEX

DAYSOR

UNITS

F. H. I. J.24. A. B. C. D. E.

PROVIDER ID. #

17. NAME OF REFERRING PROVIDER OR OTHER SOURCE 17a.

EMGRENDERING

32. SERVICE FACILITY LOCATION INFORMATION 33. BILLING PROVIDER INFO & PH #

NUCC Instruction Manual available at: www.nucc.org

c. INSURANCE PLAN NAME OR PROGRAM NAME

Full-Time Part-Time

17b. NPI

a. b. a. b.

NPI

NPI

NPI

NPI

NPI

NPI

APPROVED BY NATIONAL UNIFORM CLAIM COMMITTEE 08/05

G.EPSDTFamilyPlan

ID.QUAL.

NPI NPI

CHAMPUS

( )

APPROVED OMB-0938-0999 FORM CMS-1500 (08/05)

www.Osiris.com

The Grafix Reimbursement Hotline is comprised of a specialized team with experience in wound care

reimbursement to support providers and customers in a variety of ways, such as provider education

on coverage, coding, and payment mechanisms for Grafix.

Grafix Reimbursement Hotline staff provides assistance with the following:

• General product and service questions

• Coding and reimbursement education

• Patient-specific insurance verification

• Payer policy and LCD review and tracking

• Prior authorization and pre-determination

• Claim support

Reimbursement Hotline staff can also provide you with information about procedure codes and modifiers, and can help providers review individual payer policies to determine if other codes or a particular modifier is necessary.

Staff can provide pre-populated payer prior authorization forms, a template letter of medical necessity, submit materials on behalf of the physician and track outcomes until a final reimbursement decision is obtained.

The Grafix® Reimbursement Hotline1-855-947-2349 (855-9GRAFIX) FAX: 1-855-850-3005

1. Complete the Insurance Request Form

2. Fax to the Grafix Reimbursement Hotline:

(855) 850-3005

If you have any questions,

please call 855-947-2349 (855-9GRAFIX)

HOW DO I GET STARTED?


Disclaimer: The Grafix® Reimbursement Hotline is an information service only. Information gathered during requested research will be providedby the insurer or third-party payer. Results of this research are not a guarantee of coverage or reimbursement now or in the future, and theGrafix Reimbursement Hotline and Osiris Therapeutics disclaim liability for payment of any claims, benefits or costs.

New Wound Additional Application Re-verification New InsurancePATIENT AND PAYER INFORMATION

:htriB fo etaD:emaN tneitaP Female Male

:edoC piZ :etatS:ytiC:sserddA

:rebmuN ytiruceS laicoS:enohP

Is the patient currently in a Skilled Nursing Facility or Nursing Home? Yes No

:ecnarusnI yradnoceS:ecnarusnI yramirP

:# enohP reyaP:# enohP reyaP

:rebmuN yciloP :rebmuN yciloP

:emaN rebircsbuS:emaN rebircsbuS

PHYSICIAN AND FACILITY INFORMATION

:ytlaicepS :emaN naicisyhP

:# redivorPdiacideM:DIxaT:IPNs# DI naicisyhP

Facility Name:

:edoC piZ :etatS:ytiC:sserddA

Facility’s ID #s :DI xaT :IPN

:# xaF :# enohP :tcatnoC ytilicaF

Email Address:Treatment Setting : Hospital Based Outpatient Wound Department (HOPD) Physician Office

Ambulatory Surgery Center (ASC) Skilled Nursing Facility (SNF) Other:

Grafix® RESEARCH INFORMATION

ICD-9 Diagnosis Codes:Primary: Secondary: Tertiary:

No Applicable Secondary or Tertiary Diagnoses to Report

Known Comorbidities:

Application Codes:

:snoitacilppA fo rebmuN:ycneuqerF :etaD tratS tnemtaerT detapicitnA

If the payer requires a Prior Authorization for the Grafix® applications, would you like assistance? Yes No

AUTHORIZATION FOR RESEARCH* Do you have a Business Associate Agreement (BAA) signed with Osiris Therapeutics? Yes No

By signing below, I certify that I have obtained a valid authorization from the patient listed on this form, permitting me to release the patient’s protected health information to the Grafix® Matrix Reimbursement Hotline, Osiris Therapeutics, and/ or to its contractors as necessary to obtain insurance coverage and payment information regarding Grafix® products.

Signature of Qualified Healthcare Professional: ___________________________________________________ Date:____________________

(Patient Signature Optional):By signing this authorization, I, the patient, authorize my healthcare provider to use and/or disclose protected health information (PHI) related to Grafix®

products from my health records and insurance information to the Grafix® Matrix Reimbursement Hotline, Osiris Therapeutics, and/ or to its contractorsas necessary to obtain insurance coverage and payment information regarding Grafix® products. I understand that the information I authorize a personor entity to disclose may be shared with other people or entities and will no longer be protected by federal privacy regulations. In carrying out theseactivities, the Grafix® Matrix Reimbursement Hotline, Osiris Therapeutics, and/ or to its contractors may relay information to health insurer(s), receiveinformation from health insurer(s), and communicate such information to my healthcare provider. I understand that this authorization is voluntary andthat I may refuse to sign this authorization. I understand that my refusal to sign does not affect payment for services, my ability to obtain treatment, ormy eligibility for benefits. I understand that if I choose to revoke this authorization, I must do so in writing to my healthcare provider.

Signature of Patient or Guardian: ______________________________________________________________ Date:____________________

Please fax this form along with a copy of the front and back of the patient’s insurance card to 855-850-3005.

Grafix® Reimbursement HotlineInsurance Request Form

Phone: 855-9-GRAFIX (855-947-2349) • Fax: 855-850-3005

Osiris, the Osiris logo, and Grafix are registered trademarks of Osiris Therapeutics, Inc.

© 2015 Osiris Therapeutics, Inc. All rights reserved. G15100

7015 Albert Einstein DriveColumbia, MD 210461-888-OSIRIS 1www.Osiris.com

Grafix®PRIME Grafix®CORE

Documents

Grafix Reimbursement Guide