Reimbursement Guide 2019 - Osiris Therapeutics...2019/03/27 · this billing guide, including coding information, is supplied for informational purposes only and does not represent

Reimbursement Guide 2019Hospital Outpatient Department

Osiris Reimbursement HotlinePhone: 866-988-3491Fax: 866-304-6692 • 443-472-4274

Osiris Customer SupportPhone: 888-674-9551

Grafix and GrafixPL 2019 Reimbursement Guide

for the Hospital Outpatient Department

Table of Contents

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

Grafix Product Description ................................................................................... 2

Osiris Reimbursement Support ............................................................................ 3

CPT Coding and Medicare National Average Payments in HOPD and ASC ........ 4

Grafix HCPCS Codes, Billable Units, MUE and Modifiers .................................... 5

ICD-10-Diagnosis Codes ..................................................................................... 6

Common ICD-10 Codes for Lower Extremity Ulcers (DFU and VLU) ................ 7-8

Sample HOPD UB04 Claim Form ........................................................................ 9

Glossary of Reimbursement Terms ................................................................... 10

Pre-Treatment Checklist for Advanced Wound Therapy .................................... 11

Osiris Reimbursement Hotline Phone: 866-988-3491 Fax: 866-304-6692 / 443-472-4272

2019 Grafix and GrafixPL Reimbursement Guide (RE19005/REV00) 1

Reimbursement Disclaimer

The 2019 Reimbursement Guide only provides information related to the use of Grafix and

GrafixPL in the treatment of chronic lower extremity ulcers. Reimbursement guidance included in

this billing guide, including coding information, is supplied for informational purposes only and

does 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, services provided, local payer instructions, and other factors. Coding requirements are

subject to change at any time; please check with your local payer regularly for updates.

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 and billing appropriately for services

provided.


Reimbursement Guide

Product Description

Grafix® and GrafixPL® are allografts derived from donated human placental tissue and used as an adjunct to standard wound care in the treatment of acute and chronic wounds. Grafix is available as a cryopreserved chorion matrix (Grafix CORE®) and a cryopreserved amnion matrix (Grafix PRIME®). GrafixPL PRIME® is a lyopreserved amnion matrix. All Grafix products retain the extracellular matrix, growth factors, and viable cells of the native tissue. Grafix products are regulated as a Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P) as defined in 21 CFR Part 1271 and Section 361 of the Public Health Service Act.

Grafix and GrafixPL are processed from human placental tissue that has been donated by healthy mothers who have undergone a full-term pregnancy and delivered a healthy infant via cesarean section. Grafix products are processed aseptically in a controlled clean room environment, using methods designed to prevent contamination and cross-contamination of the HCT/P following rigorous quality assurance standards, and then stored and distributed for use in accordance with the regulations in 21 CFR 1271, the standards of the American Association of Tissue Banks (AATB) and applicable state regulations.

Reimbursement and Coding Guide

Reimbursement and coverage eligibility for the use of Grafix products and associated procedures varies by Medicare and payers. Coverage policies, prior authorizations, contract terms, billing edits, and site of service influence reimbursement. Providers should verify payer coverage and billing policies.

PLEASE NOTE: The payments specified in this document reflect Medicare national unadjusted published

payments from the Centers for Medicare and Medicaid Services (CMS). Actual payment rates will vary based on geographical adjustments. As such, all codes provided herein shall not be construed as a

warranty, statement, promise, or guarantee that these codes are accurate or that the product will be

covered in all instances, and if covered, that reimbursement in the amounts specified will be received.


Osiris Reimbursement Support

Osiris Reimbursement Hotline

For assistance with reimbursement questions, contact the Osiris Reimbursement Hotline at 866-988-3491. Normal business hours are 8:00 am - 7:00 pm eastern time.

Osiris Reimbursement Hotline staff can assist with the following:

Patient-specific insurance verifications

Payer policy and Medicare Local Coverage Determination (LCD) information

Nurse Case Manager review of documentation and coding

Prior authorization and pre-determination support

Individual claims support

General coding and reimbursement questions

Provider Responsibility:

The provider is responsible for verifying individual contract or reimbursement rates with each payer. The Osiris Reimbursement Hotline is not able to confirm contracted or reimbursable rates on your behalf.

How to Request Reimbursement Support?

Before Osiris will provide any reimbursement services, the healthcare facility must:

(a) Submit a complete Insurance Verification Request Form (IVR) with a signed practitioner authorization or signed patient authorization and fax to 866-304-6692

AND

(b) Enter into a Business Associate Agreement with Osiris* *Prior to Osiris providing any individualized reimbursement support services, which requires access to Protected Health Information (PHI), the health care facility (covered entity) and Osiris must enter into a Business Associate Agreement (BAA), or have each patient sign a Patient Authorization Form to submit with the IVR. A Business Associate Agreement template and Patient Authorization Form are available from the Osiris Hotline upon request.


CPT Procedure Codes and Medicare Payments

Medicare has designated specific CPT codes (15271-15278) for facilities to report the application of skin substitute graft procedures when used with high-cost skin substitute products. The selection of the code is based upon the location and size of the defect. Ensure the medical record reflects these elements and a procedure description including the fixation method. For Medicare, reimbursement for product, debridement, and dressings are packaged into the APC payment rate for the procedure code (not separately paid) when CTPs/skin substitutes are applied in the hospital outpatient/ASC setting. Products should still be listed separately by HCPCS code.

Coding Outpatient Hospital ASC

*CPT

Codes

Code Description

APC

Status

Indicator

2019 Medicare

National Avg.

Payment

Status

Indicator

2019 Medicare

National Avg.

Payment

15271

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

5054

T

$1,548.96

G2

$797.93

+15272

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

N

Packaged

N1

Packaged

15273

Application of skin substitute graft to trunk, arms, legs, 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

5055

T

$2,766.13

G2

$1,424.94

+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)

N

Packaged

N1

Packaged

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

5054

T

$1,548.96

G2

$797.93

+15276

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

N

Packaged

N1

Packaged

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

5054

T

$1,548.96

G2

$797.93

+15278

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)

N

Packaged

N1

Packaged

*CPT codes with a "+" sign in front signifies an add-on code and must be billed in addition to the code listed immediately above it for additional sq cm used. For example, 30 sq cm applied on the foot would be billed as: 1 unit of 15275 and 1 unit of 15276.

Status Indicators: T: Significant procedure, multiple reduction applies N: Items and services are packaged into APC rate G2: Non office-based surgical procedure added in CY 2008 or later; payment based on OPPS relative payment weight N1: Packaged service/item; no separate payment made CPT is a trademark of the American Medical Association.


Product HCPCS Codes and Modifiers

Grafix HCPCS Codes, UPC Codes and Billing Units:

Grafix and GrafixPL are billed per square centimeter. One billable unit is 1 cm2. The below chart lists the

assigned HCPCS codes for Grafix and GrafixPL products and the billable units per product size.

Medically Unlikely Edit (MUE):

The MUE is the maximum units of a product reimbursed in one application per day.

MUE for Grafix CORE Q4132 = 50 units

MUE for Grafix PRIME Q4133 = 113 units

HCPCS Billing Example:

Report accurate billing units of service consistent with the square centimeter (sq cm) units described in the HCPCS Q-code product descriptor. Below is an example of how to calculate the sq cm and billing units:

For GrafixPL PRIME Size 3 x 4 cm; 3 x 4 = 12 sq cm (billing units is 12)

Reporting Product Wastage:

Payers will typically reimburse for the entire square centimeter tissue graft. However, most payers require that providers report wastage using the JW Modifier according to the payer guidelines. Providers are expected to use the graft size that best fits the size of the wound being covered.

Preservation

and StorageProduct Description

Osiris Part

NumberUPC Code

Billing Units

(per sq cm)

HCPCS

Q-Code

GrafixPL PRIME 16 mm Disc (2 cm2) PS13016 859857003395 2 Q4133

GrafixPL PRIME 1.5 x 2 cm (3 cm2) PS13015 859857003388 3 Q4133

GrafixPL PRIME 2 x 3 cm (6 cm2) PS13023 859857003371 6 Q4133




Grafix PRIME 16 mm Disc (2 cm2) PS60013 859857003340 2 Q4133

Grafix PRIME 1.5 x 2 cm (3 cm2) PS11015 859857003081 3 Q4133

Grafix PRIME 2 x 3 cm (6 cm2) PS11023 859857003067 6 Q4133



Grafix CORE 16 mm Disc (2 cm2) PS60014 859857003333 2 Q4132

Grafix CORE 1.5 x 2 cm (3 cm2) PS12015 859857003104 3 Q4132

Grafix CORE 2 x 3 cm (6 cm2) PS12023 859857003050 6 Q4132



Lyopreserved

and stored at room

temperature

Cryopreserved and

stored at

-75°C to -85°C


ICD-10 Diagnosis Codes

Diagnosis Code Guidelines for Wound Care:

Providers should follow payer coding guidelines. Grafix and GrafixPL coverage is based on medical necessity

and subject to payer coverage guidelines. For most payers, Grafix and GrafixPL are considered medically

necessary as an adjunct in the treatment of chronic ulcers that fail to progress toward healing after a period of

standard wound care.

Payers typically require a diagnosis of the etiology, the primary reason the wound is not healing. While Grafix

and GrafixPL are indicated as an adjunct in the treatment of acute and chronic wounds, payer coverage is often

limited to chronic ulcers of the lower extremities. Always follow payer coverage guidelines for covered

indications. Examples of common causes of lower-extremity chronic wounds include:

Diabetic foot ulcers (DFU)

Diabetic ulcers of the lower extremities (ankle)

Venous stasis ulcers (VSU) / venous leg ulcers (VLU)

Pressure ulcers

Chronic non-healing surgical or trauma wounds of the lower extremity (delayed healing in surgical and

trauma wounds may also be from diabetes, vascular disease, pressure, or other disease)

ICD-10 Codes

It is recommended that providers select the most specific primary and secondary diagnosis codes to accurately

describe the reason the wound is not healing properly, and codes that indicate the wound is chronic and describe

the location, severity, and laterality (for lower extremity ulcers).

Example of specific DFU codes:

Primary diagnosis: E11.621, type 2 diabetes mellitus with a foot ulcer

Secondary diagnosis: L97.522, non-pressure chronic ulcer of other part of left foot with fat layer exposed

Example of specific VLU codes:

Primary diagnosis: I87.312, chronic venous hypertension (idiopathic) with ulcer of left lower extremity

Secondary diagnosis: L97.222, non-pressure chronic ulcer of left calf with fat layer exposed

Unspecified Codes:

Unspecified code options, which indicate to the payer that the documentation was incomplete, may lead to claim adjudication issues, including denials or review of documentation. Avoid use of unspecified codes when billing for Grafix and GrafixPL, or any other skin substitute product. Examples of unspecified diagnosis codes are:

L97.40, non-pressure chronic ulcer of unspecified heal and midfoot

L97.509, non-pressure chronic ulcer of the other part of unspecified foot with unspecified severity

For reference, pages 7-8 of this Billing Guide provide a list of ICD-10-CM codes related to chronic ulcers of the lower extremity. These codes are provided for information only and are not a statement or guarantee of reimbursement. The provider is ultimately responsible for verifying coverage with the patient’s payer source.


Common ICD-10 codes associated with chronic lower extremity ulcers

The ICD-10 codes listed below represent some of the etiology diagnosis codes commonly associated with causes of lower extremity chronic ulcers. This is not meant to be an exhaustive list. See page 8 for a list of specific non-pressure lower extremity chronic ulcer codes.

CODE DESCRIPTION

DIABETIC ULCER CODES (Not meant to be an exhaustive list)

E10.621 Type 1 diabetes mellitus with foot ulcer

E10.622 Type 1 diabetes mellitus with other skin ulcer

E11.621 Type 2 diabetes mellitus with foot ulcer

E11.622 Type 2 diabetes mellitus with other skin ulcer

E13.621 Other specified diabetes mellitus with foot ulcer

E13.622 Other specified diabetes mellitus with other skin ulcer

VENOUS ULCER CODES (Not meant to be an exhaustive list)

I83.012 Varicose veins of right lower extremity with ulcer of calf

I83.013 Varicose veins of right lower extremity with ulcer of ankle

I83.014 Varicose veins of right lower extremity with ulcer of heel & midfoot

I83.015 Varicose veins of right lower extremity with ulcer of other part of foot

I83.018 Varicose veins of right lower extremity with ulcer of other part of lower leg

I83.022 Varicose veins of left lower extremity with ulcer of calf

I83.023 Varicose veins of left lower extremity with ulcer of ankle

I83.024 Varicose veins of left lower extremity with ulcer of heel & midfoot

I83.025 Varicose veins of left lower extremity with ulcer of other part of foot

I83.028 Varicose veins of left lower extremity with ulcer of other part of lower leg

I83.212 Varicose veins of right lower extremity with both ulcer of calf and inflammation

I83.213 Varicose veins of right lower extremity with both ulcer of ankle and inflammation

I83.214 Varicose veins of right lower extremity with both ulcer of heel & midfoot and inflammation

I83.215 Varicose veins of right lower extremity with both ulcer of other part of foot and inflammation

I83.218 Varicose veins of right lower extremity with both ulcer of other part of lower extremity and inflammation

I83.222 Varicose veins of left lower extremity with both ulcer of calf and inflammation

I83.223 Varicose veins of left lower extremity with both ulcer of ankle and inflammation

I83.224 Varicose veins of left lower extremity with both ulcer of heel & midfoot and inflammation

I83.225 Varicose veins of left lower extremity with both ulcer of other part of foot and inflammation

I83.228 Varicose veins of left lower extremity with both ulcer of other part of lower extremity and inflammation

I87.2 Venous Insufficiency (chronic peripheral)

I87.311 Chronic venous hypertension (idiopathic) with ulcer of right lower extremity

I87.312 Chronic venous hypertension (idiopathic) with ulcer of left lower extremity

I87.313 Chronic venous hypertension (idiopathic) with ulcer of bilateral lower extremity

I87.331 Chronic venous hypertension (idiopathic) with ulcer and inflammation of right lower extremity

I87.332 Chronic venous hypertension (idiopathic) with ulcer and inflammation of left lower extremity

I87.333 Chronic venous hypertension (idiopathic) with ulcer and inflammation of bilateral lower extremity


Common ICD-10 codes associated with chronic lower extremity ulcers

The ICD-10 codes listed below are specific diagnosis codes commonly associated with non-pressure chronic ulcers of the lower extremity. This is not meant to be an exhaustive list.

CODE DESCRIPTION

L97 SERIES NON-PRESSURE CHRONIC ULCER OF LOWER LIMB

L97.211 Non-Pressure Chronic Ulcer of Right calf limited to breakdown of skin

L97.212 Non-Pressure Chronic Ulcer of Right calf with fat layer exposed

L97.213 Non-Pressure Chronic Ulcer of Right calf with necrosis of muscle

L97.214 Non-Pressure Chronic Ulcer of Right calf with necrosis of bone

L97.221 Non-Pressure Chronic Ulcer of Left calf limited to breakdown of skin

L97.222 Non-Pressure Chronic Ulcer of Left calf with fat layer exposed

L97.223 Non-Pressure Chronic Ulcer of Left calf with necrosis of muscle

L97.224 Non-Pressure Chronic Ulcer of Left calf with necrosis of bone

L97.311 Non-Pressure Chronic Ulcer of Right ankle limited to breakdown of skin

L97.312 Non-Pressure Chronic Ulcer of Right ankle with fat layer exposed

L97.313 Non-Pressure Chronic Ulcer of Right ankle with necrosis of muscle

L97.314 Non-Pressure Chronic Ulcer of Right ankle with necrosis of bone

L97.321 Non-Pressure Chronic Ulcer of Left ankle limited to breakdown of skin

L97.322 Non-Pressure Chronic Ulcer of Left ankle with fat layer exposed

L97.323 Non-Pressure Chronic Ulcer of Left ankle with necrosis of muscle

L97.324 Non-Pressure Chronic Ulcer of Left ankle with necrosis of bone

L97.411 Non-Pressure Chronic Ulcer of Right heel & midfoot limited to breakdown of skin

L97.412 Non-Pressure Chronic Ulcer of Right heel & midfoot with fat layer exposed

L97.413 Non-Pressure Chronic Ulcer of Right heel & midfoot with necrosis of muscle

L97.414 Non-Pressure Chronic Ulcer of Right heel & midfoot with necrosis of bone

L97.421 Non-Pressure Chronic Ulcer of Left heel & midfoot limited to breakdown of skin

L97.422 Non-Pressure Chronic Ulcer of Left heel & midfoot with fat layer exposed

L97.423 Non-Pressure Chronic Ulcer of Left heel & midfoot with necrosis of muscle

L97.424 Non-Pressure Chronic Ulcer of Left heel & midfoot with necrosis of bone

L97.511 Non-Pressure Chronic Ulcer of Other part of right foot limited to breakdown of skin

L97.512 Non-Pressure Chronic Ulcer of Other part of right foot with fat layer exposed

L97.513 Non-Pressure Chronic Ulcer of Other part of right foot with necrosis of muscle

L97.514 Non-Pressure Chronic Ulcer of Other part of right foot with necrosis of bone

L97.521 Non-Pressure Chronic Ulcer of Other part of left foot limited to breakdown of skin

L97.522 Non-Pressure Chronic Ulcer of Other part of left foot with fat layer exposed

L97.523 Non-Pressure Chronic Ulcer of Other part of left foot with necrosis of muscle

L97.524 Non-Pressure Chronic Ulcer of Other part of left foot with necrosis of bone

L97.811 Non-Pressure Chronic Ulcer of Other part of right lower leg limited to breakdown of skin

L97.812 Non-Pressure Chronic Ulcer of Other part of right lower leg with fat layer exposed

L97.813 Non-Pressure Chronic Ulcer of Other part of right lower leg with necrosis of muscle

L97.814 Non-Pressure Chronic Ulcer of Other part of right lower leg with necrosis of bone

L97.821 Non-Pressure Chronic Ulcer of Other part of left lower leg limited to breakdown of skin

L97.822 Non-Pressure Chronic Ulcer of Other part of left lower leg with fat layer exposed

L97.823 Non-Pressure Chronic Ulcer of Other part of left lower leg with necrosis of muscle

L97.824 Non-Pressure Chronic Ulcer of Other part of left lower leg with necrosis of bone


Claim Form

HOPD or Hospital-Affiliated ASC:

This example represents the application of Grafix PRIME, 3 x 4 cm (12 cm2), to an area on the foot, conducted in the HOPD or hospital-affiliated ASC on the UB04 claim form (also known as the CMS-1450).

MK-

0212.5 03/2018

CPT Code

HCPCS Code

Billing Units

Service Description

Primary and Secondary

ICD-10 Codes


Glossary of Reimbursement Terms

Medicare Area Contractors (MAC): The Centers for Medicare and Medicaid Services (CMS) contracts with regional Medicare Area Contractors (MACs) to administer the Medicare program. Each MAC establishes its own set of guidelines for the coverage of services. The coverage guidelines are published by each MAC as a Local Coverage Determination (LCD).

Coinsurance/Deductibles: As with all products and services paid for under Medicare Part B, Medicare reimburses 80 percent of the allowable amount. The patient, or secondary/supplemental plan, is responsible for the remaining 20 percent coinsurance amount. The appropriate annual deductibles also apply. Sequestration: Since April 1, 2013, all Medicare claims with a date-of-service on or after April 1, 2013 are subjected to a 2 percent sequestration amount, which remains in effect in the U.S. budget until 2022. Please note, the 2 percent is deducted from the 80 percent allowable amount paid by Medicare and not the coinsurance amount. Wage Index: The referenced payment amounts in this guide are based on the national average payment amounts listed by Medicare. The actual amount which a hospital or provider receives is adjusted by the area wage index. It is intended to account for regional differences in the cost of wages and cost of conducting business. APC: Ambulatory Payment Classification Packaged Payment: A payment method in which all services provided during a specified episode of care are packaged or bundled into one APC payment. Reimbursement for CTPs/skin substitutes and the facility payment for the procedure and related services in the HOPD/ASC setting of care are packaged for each treatment into one bundled payment. Debridement: Debridement is considered a component code of skin substitute CPT application codes and is not separately reimbursed by Medicare. Many insurers have specific guidelines on debridement services. Check with the insurer for insurer-specific guidance. Physician Services Payment for Application of Grafix in an HOPD or ASC: When Grafix is used in the outpatient department, the treating physician will separately bill for the physician’s services (e.g. application procedure) on the CMS-1500 claim form using the same CPT code(s) billed by the facility. Modifiers: Check payer billing guidelines to see if modifiers are required with HCPCS and/or the CPT codes used. Common modifiers may include:

JC: skin substitute used as a graft

JW: wastage

KX: requirements in the medical policy have been met Ulcer Size: Determine the ulcer location and surface area, in order to select the appropriate CPT and ICD-10 codes. Ulcer size, as measured according to acceptable practice standards, should be documented in the medical record weekly, including the Length (L), Width (W) and Depth (D) in cm. Initial coverage is typically based on documentation that the wound is not improving, or reducing in size over time, and has become a chronic ulcer.


Advanced Therapy Pre-Treatment Checklist

Prior to requesting insurance verification or prior authorization from a payer, the provider should have documentation of the following in the patient’s medical record:

Diagnosis of a chronic wound and the causation or etiology (i.e. Type II Diabetes)

o Primary (etiology) and Secondary (chronic ulcer) ICD-10 codes

Failure to respond to good standard wound care for ≥4 weeks (Be specific about modalities

such as debridement, advanced dressings, collagen, etc.)

Underlying disease or condition is being treated by licensed physician and is under control:

o Diabetes – HbA1c <12%

o Venous stasis – adequate compression therapy to control edema

Blood perfusion is adequate (ABI ≥0.65 or toe pressure ≥30 mmHg, pedal pulse)

Venous reflux studies for venous stasis ulcer diagnosis

Patient is compliant with off-loading for DFU or compression for VLU (document type)

Absence of acute wound infection or active osteomyelitis – must state in the record

o If the patient has a history of osteomyelitis, recent X-rays are negative for active osteomyelitis and the patient’s chart documents stating the osteomyelitis is not active

For patients with history of Charcot neuroarthropathy, include documentation that acute Charcot Foot is not present, and any history of acute Charcot Foot has been treated

Weekly wound measurements taken; wound size is ≥1 cm2 when initiating therapy

Smoking Status – smokers have been educated that smoking impairs wound healing, counselled to stop, and provided cessation resources to curb smoking

The patient is adequately nourished to support wound healing

Documented treatment plan; to include the use of advanced therapies

Documents

Reimbursement Guide 2019 - Osiris Therapeutics...2019/03/27 · this billing guide, including coding information, is supplied for informational purposes only and does not represent