2017 - amazon s3 · example letter 22 6 plan denial appeal process ... (cts) to source and process...

RESOURCE GUIDE

REIMBURSEMENT

Reimbursement Hotline Phone: 1.844.225.2228

Fax: 1.240.238.9836

Email: [email protected]

Prepared by Musculoskeletal Clinical Regulatory Advisers, LLC. and Tissue Regenix Wound Care Inc. Ver. V2 12/17

Disclaimer: This information is for educational/informational purposes only and should not be construed as authoritative. The information presented here is current as of January 2017 and

is based upon publicly available source information. Codes and values are subject to frequent change without notice. The entity billing Medicare and/or third party payors is solely

responsible for the accuracy of the codes assigned to the services or items in the medical record. When making coding decisions, we encourage you to seek input from the AMA,

relevant medical societies, CMS, your local Medicare Administrative Contractor and other health plans to which you submit claims. Items and services that are billed to payors must be

medically necessary and supported by appropriate documentation. It is important to remember that while a code may exist describing certain procedures and/or technologies, it does

not guarantee payment by payors.

2017

2017 Reimbursement Guide V2 16-12-19

www.TissueRegenixUS.com

2

REIMBURSEMENT RESOURCE GUIDE

Section Description Page

1 DermaPure® Product

Overview

3

2 Coding Basics 5

3 Coding Pathways by Place

of Service

7

4 Documentation Support 19

5 Pre-Authorization Overview 20

5.1 Pre-Authorization –

Example Letter

22

6 Plan Denial Appeal Process

Overview

25

7 Resources for DermaPure®

Technology Support

27

8 Coverage Summaries 27

9 Sample Billing Forms 29

www.TissueRegenixUS.com

3

1. DermaPure® Product Overview

What is DermaPure®?

DermaPure® is a decellularized dermal skin allograft produced from split

thickness skin grafts (which comprise the epidermis and upper part of the

dermis) retrieved from deceased tissue donors. All epidermal and cellular

components from the dermis are removed in a patented sequential

decellularization process.

DermaPure® is obtained from deceased tissue donors within the United States

who have chosen to donate medically desired tissue following their death for

the benefit of others. Tissue Regenix partners with Community Tissue Services

(CTS) to source and process tissue for allograft use. Tissue Regenix and CTS are

committed to honoring the last wish of each donor by providing recipients and

surgeons with a trusted source of allograft implants.

The donated split skin grafts undergo a multi-step process that removes the

epidermis and any donor cells and cell remnants from the graft, a procedure

known as decellularization. The particular decellularization procedure used is

done by a patented method, dCELL® Technology, that was developed by

scientists at the University of Leeds. The dCELL Technology process involves

sequentially incubating the skin grafts in different reagents to achieve this

goal:

Incubation in a hypertonic solution, to remove the epidermis

Incubation in a hypotonic solution, to lyse dermal cells

Incubation in a detergent solution, to remove cell remnants

Incubation in a solution of nuclease enzymes, to remove nucleic acids.

Unlike many conventional methodologies, the dCELL® Technology process

does not use high-concentration detergents or chemical fixatives that may

otherwise cause damage to the underlying extra-cellular collagen matrix.

After decellularization, the dermis grafts are sterilized with gamma irradiation

to achieve a Sterility Assurance Level (SAL) of 10-6. It has been shown with in

vitro and in vivo validation that this process results in a graft which is non-toxic,

biocompatible, and non-immunogenic.

Cellular skin allografts, such as those used to treat severe burn wounds, can

only temporarily engraft to a wound, as the donor cells within the graft

provoke an immune response which results in the graft being rejected. By

removing donor cells and cell remnants, decellularization treatment

4

produces a graft which consists of a much less immunogenic extracellular

matrix, which can serve as a permanent implant, to provide a scaffold that

can be repopulated with the recipient’s own cells. The dCELL® Technology

process enables effective removal of up to 99% DNA from donor tissue. The

scaffold retains the essential structures of normal skin, including vascular

channels and a basement membrane which is essential for regeneration of

the epidermis. These structures can only be replicated in a graft material

which is prepared from donated human dermis tissue.

DermaPure® transforms wound management by signaling the body, not the

wound. Peer reviewed published research provides evidence that when

utilizing DermaPure® within 7 days there is evidence of native cells key to

healing the wound (endothelial cells and fibroblasts) present in the wound

bed. Additional published evidence shows that by day 21 there is a

statistically significant increase in proangiogenic factors such as PROK2, MT6-

MMP and CD31. All of these factors are important to closing the patient’s

wound. In many instances only one application of DermaPure® is necessary.

DermaPure® 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, subject to Section 361 of the Public Health Service Act and

21 CFR 1270 and 1271.

The Tissue Regenix manufacturing partner, Community Tissue Services (CTS),

uses the experience of licensed Medical Doctors to assist in the donor

screening process prior to recovery. CTS only accepts tissue donors that meet

or exceed donor eligibility requirement set in place by the Food and Drug

Administration (FDA), American Association of Tissue Banks, state regulations,

and Community Tissue Services in-house Medical Directors.

Each donor is thoroughly evaluated using a medical/social history

assessment, medical records, blood tests, culture results, physical examination

and autopsy reports (when performed). This process is used to ensure the

donor is suitable for donation by providing a means to recognize and exclude

potential diseases or medical conditions that are unacceptable.

Processing and packaging of the tissue are performed using aseptic

technique and occur in a class 100 clean room. In addition to the already

discussed screening and testing applied to donors, the decellularization

protocol removes cells that can harbor intra-cellular viruses and other

infectious agents. Tissue grafts are rinsed and soaked in various solutions to

minimize the potential for transmission of bacteria and viruses. The inclusion of

a sterilization treatment further reduces the already remote possibility of

disease transmission.

5

2. Coding Basics

Whenever code assignment is discussed for new or existing procedures or

technologies, the different coding and reimbursement pathways and types of

code sets used should be reviewed. Distinct code sets are used to report

various aspects of procedures and technologies for reimbursement

depending on the entity billing the case.

Reimbursement pathways and appropriate code sets take two directions

resulting in two separate reimbursements for a single patient encounter when

performed in a facility. Physicians report their work separately from the facility

where the procedure is performed. This in turn creates unique coding

pathways for each side of the equation that results in appropriate

reimbursement from third party payors (such as Medicare or private payors).

When procedures indicated for the use of DermaPure® are performed within

the physician office setting of care the physician may be reimbursed not only

for the work performed during the procedure but also for the office expenses

and supplies such as DermaPure®, that are included in the procedure. The

extent of available reimbursement for an in office procedure is dependent on

specific payor guidelines and should be reviewed for each case through a

pre-authorization or benefits verification.

Physician Codes – Physician services and surgical procedures are reported

using Common Procedural Terminology (CPT®)1 codes. These codes are

created by the American Medical Association (AMA). These codes are

reported across all settings of care including the physician office, outpatient

and inpatient facility. Medicare and many private health plans rely primarily

1 American Medical Association CPT Codes and descriptions are copyright of the American Medical Association.

All rights reserved.

Surgical Case

Physician Reimbursement Codes Facility Reimbursement Codes

Inpatient Codes Outpatient Codes

6

on CPT codes to describe procedures performed in the physician office,

ambulatory surgery center (ASC), and hospital outpatient department. CPT

codes are developed, maintained, and annually updated by the AMA. Please

note that the assignment of a CPT code to a procedure does not guarantee

coverage or payment by a health plan in all cases.

Under Medicare’s Resource-Based Relative Value Scale (RBRVS) methodology

each CPT code is assigned a value, the relative value unit (RVU), which is then

converted to a payment amount.

Facility Codes – Surgical procedures are performed in the office, outpatient or

inpatient setting of care, as determined by the physician. Each setting utilizes

a different code set to report their services to the payor for reimbursement. This

is in addition to the physician, who reports his services separately with CPT

codes.

Outpatient APC Codes, are based on the same CPT codes reported by

physicians but these are typically mapped to or placed into a second code

set called Ambulatory Payment Classification (APC) Codes. APC codes

combine CPT procedure services into like groupings that utilize similar resources

in the outpatient setting and are paid an established rate for the particular

APC. These APC code sets can be reported and reimbursed singularly or in

inclusive groupings, as determined by payor guidelines. Government payors

and some private payors use this system but reimbursement guidelines can

differ considerably depending on the payor and contracted agreements.

Medicare reimbursement rates are determined by the Outpatient Prospective

Payment System (OPPS) and are published semi-annually.2

Physician, hospital outpatient and hospital inpatient coding is provided in this

document, along with key considerations for addressing the status of the

codes provided. The 2017 Medicare national average reimbursement rates

have also been included for applicable codes.

The coding pathways provided within this document address the use of

DermaPure® in wound care procedures and the reporting of the skin substitute

graft material. Medicare place of service guidelines and reimbursement rates

are provided as a benchmark for the applicable procedures. Private Payor

reimbursement rates and guidelines are carrier and plan specific and may

differ significantly from the benchmark rates. Anecdotally, private payor rates

are sometimes based on Medicare RVUs and may be calculated on a factor

of 120-150-% of the benchmarked Medicare rates for estimating

2 Centers for Medicare & Medicaid Services Medicare Learning Network. Hospital Outpatient Prospective Payment

System. Available at: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-

MLN/MLNProducts/downloads/HospitalOutpaysysfctsht.pdf. (Accessed 12/13/16).

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/HospitalOutpaysysfctsht.pdf

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/HospitalOutpaysysfctsht.pdf

7

reimbursements. Actual reimbursement guidelines and rates are contracted

agreements and applicable fee schedules should be reviewed.

3. Coding Pathways by Place of Service

The following information is intended for provider guidance and allows the

physician to consider his or her reporting pathways on a case by case basis.

Final decision-making regarding coding guidelines for specific third party

payors remains in the hands of the provider. Ultimately, the provider has a

better understanding of the coding pathways available and how to use them

appropriately in the office setting of care as well as in the outpatient and

inpatient facility settings of care.

Physician Coding

Physicians bill Medicare and other payors separately for services performed,

regardless of whether the service takes place in the physician’s office, a

hospital or other outpatient facility. Procedure codes identify the specific

treatment that is performed on the patient. It is possible to report more than

one procedure code on a claim form, and the type of payor and setting of

care often dictate whether the services are paid independently or as a single

bundled payment. The following tables illustrate potential CPT codes that can

be used to denote the application of DermaPure® for the treatment of

wounds. Medicare RVUs and national average payment rates have been

included for both the facility setting and the physician’s office. When services

are provided in the physician’s office (non-facility) RVUs are higher to reflect

the increased costs that the practice must absorb.

8

Physician Coding Pathways - Medicare National Average Payment 2017

CPT3

Code

CPT Description

2017

RVUs4

Non-Facility

(Office)

Medicare

National

Average

Payment

2017 Non-Facility

(Office)

2017

RVUs

Facility

Medicare

National

Average

Payment

2017 Facility

15002

Surgical preparation or creation of

recipient site by excision of open

wounds, burn eschar, or scar (including

subcutaneous tissues), or incisional

release of scar contracture, trunk, arms,

legs; first 100 sq. cm or 1% of body area

of infants and children

9.88 $354.58 6.55 $235.07

+15003





release of scar contracture, trunk, arms,

legs; each additional 100 sq. cm, or part

thereof, or each additional 1% of body

area of infants and children (List

separately in addition to code for

primary procedure)

2.15 $77.16 1.32 $47.37

15004





release of scar contracture, face, scalp,

eyelids, mouth, neck, ears, orbits,

genitalia, hands, feet and/or multiple

digits; first 100 sq. cm or 1% of body area

of infants and children

11 .39 $408.77 7.78 $279.21

+15005





release of scar contracture, face,

scalp, eyelids, mouth, neck, ears, orbits,

genitalia, hands, feet and/or multiple

digits; each additional 100 sq. cm, or

part thereof, or each additional 1% of

body area of infants and children (List


primary procedure)

3.56 $127.76 2.64 $94.75

3 CPT 2017 Professional Edition, 2017, American Medical Association 4 CMS 2017 PFS Final Rule, www.cms.gov

http://www.cms.gov/

9

CPT3

Code

CPT Description

2017

RVUs4

Non-Facility

(Office)

Medicare

National

Average

Payment

2017 Non-Facility

(Office)

2017

RVUs

Facility

Medicare

National

Average

Payment

2017 Facility

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

3.98 $142.84 2.44 $87.57

+15272



area up to 100 sq. cm; each additional

25 sq. cm wound surface area, or part

thereof (List separately in addition to

code for primary

.77 $27.63 .50 $17.94

15273



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

8.54 $306.49 5.87 $210.67

+15274



area greater than or equal to 100 sq.

cm; 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


primary procedure)

2.04 $73.21 1.33 $47.73

15275


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

4.23 $151.81 2.76 $99.05

+15276





up to 100 sq. cm; each additional 25 sq.

cm wound surface area, or part thereof

(List separately in addition to code for

primary procedure)

.99 $35.53 .73 $26.20

10

CPT3

Code

CPT Description

2017

RVUs4

Non-Facility

(Office)

Medicare

National

Average

Payment

2017 Non-Facility

(Office)

2017

RVUs

Facility

Medicare

National

Average

Payment

2017 Facility

15277





greater than or equal to 100 sq. cm; first

100 sq. cm wound surface area, or 1% of

body area of infants and children

9.31 $334.12 6.58 $236.15

+15278





greater than or equal to 100 sq. cm;

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


primary procedure)

2.44 $87.57 1.67 $59.93

When reporting office based (non-facility) skin substitute graft procedures that

are not performed in the hospital outpatient or ASC setting of care, the

product utilized in the procedure should be reported on the claim form using

the appropriate HCPCS Level II “Q” code. The third party payor determines the

coverage and reimbursement guidelines for graft material reimbursement.

One common payment methodology uses Average Sales Price (ASP) plus a

percentage. This is determined by the third party payor dependent on

coverage guidelines and is not standardized across all carriers. Each

administrative contractor, insurance carrier and case specific coverage plan

should be queried for reporting guidelines and available remuneration.

Disclaimer: This information is for educational/informational purposes only and should not be construed as authoritative.

The information presented here is current as of January 2017 and is based upon publicly available source information.

Codes and values are subject to frequent change without notice. The entity billing Medicare and/or third party payors is

solely responsible for the accuracy of the codes assigned to the services or items in the medical record. When making

coding decisions, we encourage you to seek input from the AMA, relevant medical societies, CMS, your local Medicare

Administrative Contractor and other health plans to which you submit claims. Items and services that are billed to payors

must be medically necessary and supported by appropriate documentation. It is important to remember that while a

code may exist describing certain procedures and/or technologies, it does not guarantee payment by payors.

11

Hospital Outpatient & Ambulatory Surgery Center Coding Pathways

As part of Medicare’s OPPS/ASC 2014 policy of packaging of skin substitutes

the high cost/ low cost grouping was adopted to ensure adequate resource

homogeneity among APC assignments for the skin substitute application

procedures. Medicare reimburses hospital outpatient visits based on the APC

to which a particular CPT code is assigned.

The assignment to the high cost or low cost group determines the CPT coding

pathways reportable and APC assignments for the hospital outpatient (OPPS)

and ASC skin substitute graft procedures.

The table below depicts potential hospital outpatient APC assignments and

Medicare national average payment amounts for hospital outpatient and

ASC procedures for the application of DermaPure® for the treatment of

chronic and acute wounds. Medicare national average reimbursements have

been provided as a benchmark where applicable. Commercial payors will

have established fee schedules for the application of skin substitutes utilizing

CPT coding or a combination of APC coding and/or CPT coding. This

methodology is not standardized and can vary with each provider-payor

contract.

12

Hospital Outpatient and Ambulatory Surgery Center (ASC) Coding Pathways

Hospital Outpatient5 ASC6

CPT

Code

CPT

Description APC

Status Indicator

Medicare

Payment Rate

(OPPS)

2017

Payment

Indicator

Medicare

Payment Rate

(ASC)

2017

15002 Surgical Prep 5054 T $1,427.16 A2 $770.84

15003 Each Additional

Area N/A N $0.00 N1 $0.00

15004 Surgical Prep 5053 T $452.91 A2 $244.63


Area N/A N $0.00 N1 $0.00

15271 Application of

Skin Substitute

Graft 5054 T $1,427.16 G2 $770.84


Area N/A N $0.00 N1 $0.00


Skin Substitute

Graft 5055 T $2,503.63 G2 $1,352.27


Area N/A N $0.00 N1 $0.00


Skin Substitute

Graft 5054 T $1,427.16 G2 $770.84


Area N/A N $0.00 N1 $0.00


Skin Substitute

Graft 5054 T $1,427.16 G2 $770.84


Area N/A N $0.00 N1 $0.00

(T) Multiple procedure reductions apply (per guidelines www.cms.gov)

(N) Items and Services Packaged into APC Rates

(A2) Surgical procedure on ASC list in 2007; payment based on OPPS relative payment

weight

(G2) Non-office based procedure added in CY 2008 or later; payment based on HOPPS relative payment

weight

(N1) Packaged service/item; no separate payment made

5 2017 Medicare Outpatient Prospective Payment System. www.cms.gov 6 2017 Medicare ASC Prospective Payment System. www.cms.gov

http://www.cms.gov/

http://www.cms.gov/

http://www.cms.gov/

13

Location HCPCS Description

AP

PLI

CA

TIO

N O

F S

KIN

SU

BSTI

TUTE

GR

AFT

TO:

TRU

NK,

AR

MS,

LEG

S:

15271 Total wound surface area up to 100 sq. cm; first 25 sq. cm or less wound surface area

+15272 Total wound surface area up to 100 sq. cm; each additional 25 sq. cm wound surface

area, or part thereof (List separately in addition to code for primary procedure)

15273 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

+15274 Total wound surface area greater than or equal to 100 sq. cm; 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)

FA

CE,

SC

ALP

, EY

ELI

DS,

MO

UTH

, N

EC

K,

EA

RS,

OR

BIT

S,

GEN

ITA

LIA

, H

AN

DS,

FEET,

AN

D/O

R

MU

LTIP

LE D

IGIT

S:

15275 Total wound surface area up to 100 sq. cm; first 25 sq. cm or less wound surface area

+15276 Total wound surface area up to 100 sq. cm; each additional 25 sq. cm wound surface

area, or part thereof (List separately in addition to code for primary procedure)

15277 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 Total wound surface area greater than or equal to 100 sq. cm; 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)

HCPCS CODES

DermaPure® Q4152

15271

15275

15277

+15272

+15274

+15276

+15278

15273

HEA

LTH

CA

RE S

ETT

ING

Hospital Outpatient Wound Care Center $1,427.16 $0 $2,503.63

Hospital Outpatient Surgery $1,427.16 $0 $2,503.63

Ambulatory Surgery Center $770.84 $0 $1352.27

Physician Office ASP + 6% ASP + 6% ASP + 6%

2017 Outpatient CMS Product and Related Procedure Reimbursement

Disclaimer: This information is for educational/informational purposes only and should not be construed as authoritative. The information presented here is

current as of January 2017 and is based upon publicly available source information. Codes and values are subject to frequent change without notice. The

entity billing Medicare and/or third party payors is solely responsible for the accuracy of the codes assigned to the services or items in the medical record.

When making coding decisions, we encourage you to seek input from the AMA, relevant medical societies, CMS, your local Medicare Administrative

Contractor and other health plans to which you submit claims. Items and services that are billed to payors must be medically necessary and supported by

appropriate documentation. It is important to remember that while a code may exist describing certain procedures and/or technologies, it does not

guarantee payment by payors.

14

Medicare requires that the graft material used in skin substitute procedures be

reported using the appropriate HCPCS Level II Q code. DermaPure® was

assigned a brand specific Q code (Q4152) to report after January 1, 2015 for

purposes of identifying the graft material utilized in the skin substitute

procedure reported with the CPT and APC codes above.

While there is no Medicare line item reimbursement for the graft material in the

OP/ASC settings of care, the cost of the product is included in the CPT and

APC assignment through an all-inclusive reimbursement. The Q code is

reported (See Table 4) to drive coverage determinations and allow for data

collection and cost analysis of specific skin substitute products. The exception

to this is a very few brand-specific skin substitute graft materials that have

temporary pass-through status. This does not apply to DermaPure®.

Table 4: HCPCS Coding Pathways HCPCS7 HCPCS Description High / Low Category

Q4152 DermaPure®, per square centimeter HIGH

Hospital Inpatient Coding Pathways

Medicare reimburses hospital inpatient stays based on the Medicare Severity

Diagnosis Related Group (MS-DRG) system. MS-DRGs represent a consolidated

prospective payment for all services provided by the hospital during the

patient’s hospitalization, based on submitted claims data. With limited

exceptions, the MS-DRG payment is inclusive of all services, products, and

resources, regardless of the final cost to the hospital. Medicare and many

private payors use the MS-DRG based system to reimburse facilities for

inpatient services.

7 2017 HCPCS Level II www.cms.gov

http://www.cms.gov/

15

Distinct hospital procedure coding exists for wound care and skin substitute

grafts and the application of DermaPure®. The chart below provides a small

sample of applicable ICD-10-PCS procedure codes implemented October 1,

2015. The ICD-10-PCS new ICD-10-PCS code set is specific as to anatomy,

depth of the procedure, laterality, and the type of tissue graft. The list is

exhaustive in detail. The following examples show the typical detail required to

code procedures correctly. Note that DermaPure is considered a non-

autologous tissue substitute graft.

There are many specific ICD-10-CM diagnosis codes that would be appropriate to validate the medical

necessity for utilizing DermaPure® (for example E11.621, Type 2 Diabetes with foot ulcer). A

comprehensive list would be very lengthy.

ICD-10-PCS Hospital Procedure Coding Pathways (not a complete list) ICD-10-PCS Code8 ICD-10-PCS Description

0JBR0ZZ Excision of Left Foot Subcutaneous Tissue and Fascia, Open Approach

0HBNXZZ Excision of Left Foot Skin, External Approach

0HRNXK4 Replacement of Left Foot Skin with Nonautologous Tissue Substitute, Partial

Thickness, External Approach

The specific ICD 10 code for DermaPure® is Nonautologous Tissue Substitute. (Formerly ICD-9,

86.67 Dermal Regenerative Graft)

ICD-10-PCS

Code9

Anatomy ICD-10 PCS Code

Description

0HR0XK3 Scalp Replacement of Scalp Skin with Nonautologous Tissue Substitute, Full


0HR0XK4 Scalp Replacement of Scalp Skin with Nonautologous Tissue Substitute, Partial


0HR1XK3 Face Replacement of Face Skin with Nonautologous Tissue Substitute, Full


0HR1XK4 Face Replacement of Face Skin with Nonautologous Tissue Substitute, Partial


0HR2XK3 R. Ear Replacement of Right Ear Skin with Nonautologous Tissue Substitute, Full


0HR2XK4 R. Ear Replacement of Right Ear Skin with Nonautologous Tissue Substitute,

Partial Thickness, External Approach

0HR3XK3 L. Ear Replacement of Left Ear Skin with Nonautologous Tissue Substitute, Full


0HR3XK4 L. Ear Replacement of Left Ear Skin with Nonautologous Tissue Substitute, Partial


8 2016 ICD-10-PCS www.cms.gov 9 ICD-10-PCS GEMs www.cms.gov

http://www.cms.gov/

http://www.cms.gov/

16

0HR4XK3 Neck Replacement of Neck Skin with Nonautologous Tissue Substitute, Full


0HR4XK4 Neck Replacement of Neck Skin with Nonautologous Tissue Substitute, Partial


0HR5XK3 Chest Replacement of Chest Skin with Nonautologous Tissue Substitute, Full


0HR5XK4 Chest Replacement of Chest Skin with Nonautologous Tissue Substitute, Partial


0HR6XK3 Back Replacement of Back Skin with Nonautologous Tissue Substitute, Full


0HR6XK4 Back Replacement of Back Skin with Nonautologous Tissue Substitute, Partial


0HR7XK3 Abdomen Replacement of Abdomen Skin with Nonautologous Tissue Substitute, Full


0HR7XK4 Abdomen Replacement of Abdomen Skin with Nonautologous Tissue Substitute,


0HR8XK3 Buttock Replacement of Buttock Skin with Nonautologous Tissue Substitute, Full


0HR8XK4 Buttock Replacement of Buttock Skin with Nonautologous Tissue Substitute, Partial


0HR9XK3 Perineum Replacement of Perineum Skin with Nonautologous Tissue Substitute, Full


0HR9XK4 Perineum Replacement of Perineum Skin with Nonautologous Tissue Substitute,


0HRAXK3 Genitalia Replacement of Genitalia Skin with Nonautologous Tissue Substitute, Full


0HRAXK4 Genitalia Replacement of Genitalia Skin with Nonautologous Tissue Substitute,


0HRBXK3 R. Upper

Arm

Replacement of Right Upper Arm Skin with Nonautologous Tissue

Substitute, Full Thickness, External Approach

0HRBXK4 R. Upper

Arm

Replacement of Right Upper Arm Skin with Nonautologous Tissue

Substitute, Partial Thickness, External Approach

0HRCXK3 L. Upper

Arm

Replacement of Left Upper Arm Skin with Nonautologous Tissue


0HRCXK4 L. Upper

Arm

Replacement of Left Upper Arm Skin with Nonautologous Tissue


0HRDXK3 R. Lower

Arm

Replacement of R. Lower Arm Skin with Nonautologous Tissue Substitute

Full Thickness External Approach

0HRDXK4 R. Lower

Arm

Replacement of R. Lower Arm Skin with Nonautologous Tissue Substitute,


0HREXK3 L. Lower

Arm

Replacement of Left Lower Arm Skin with Nonautologous Tissue


0HREXK4 L. Lower

Arm

Replacement of Left Lower Arm Skin with Nonautologous Tissue


0HRFXK3 R. Hand Replacement of Right Hand Skin with Nonautologous Tissue Substitute,

Full Thickness, External Approach

0HRFXK4 R. Hand Replacement of Right Hand Skin with Nonautologous Tissue Substitute,


0HRGXK3 L. Hand Replacement of Left Hand Skin with Nonautologous Tissue Substitute, Full


17

0HRGXK4 L. Hand Replacement of L Hand Skin with Nonautologous Tissue Substitute, Partial


0HRHXK3 R. Upper

Leg

Replacement of Right Upper Leg Skin with Nonautologous Tissue


0HRHXK4 R. Upper

Leg

Replacement of Right Upper Leg Skin with Nonautologous Tissue


0HRJXK3 L. Upper Leg Replacement of Left Upper Leg Skin with Nonautologous Tissue


0HRJXK4 L. Upper Leg Replacement of Left Upper Leg Skin with Nonautologous Tissue


0HRKXK3 R. Lower

Leg

Replacement of R. Lower Leg Skin with Nonautologous Tissue Substitute

Full Thickness External Approach

0HRKXK4 R. Lower

Leg

Replacement of R. Lower Leg Skin with Nonautologous Tissue Substitute,


0HRLXK3 L. Lower Leg Replacement of Left Lower Leg Skin with Nonautologous Tissue


0HRLXK4 L. Lower Leg Replacement of Left Lower Leg Skin with Nonautologous Tissue


0HRMXK3 R. Foot Replacement of Right Foot Skin with Nonautologous Tissue Substitute, Full


0HRMXK4 R. Foot Replacement of Right Foot Skin with Nonautologous Tissue Substitute,


0HRNXK3 L. Foot Replacement of Left Foot Skin with Nonautologous Tissue Substitute, Full


0HRNXK4 L. Foot Replacement of L Foot Skin with Nonautologous Tissue Substitute, Partial

Thickness, External Approach 1 2016 ICD-10-PCS www.cms.gov 1 ICD-10-PCS GEMs www.cms.gov









Medicare establishes MS-DRG groupings depending on the procedure

performed, the individual’s diagnosis, and the patient condition in order to

provide a single reimbursement value for the entire inpatient stay. Certain MS-

DRGs account for the possibility of complications and comorbidities present

on arrival to the facility or arising during the case, which complicate the case

and increase the hospital payment. The table below provides potential MS-

DRGs assignments for hospitals when applying skin substitutes for the treatment

of wounds in the inpatient setting of care. Medicare average rates are

provided as a benchmark.

http://www.cms.gov/

http://www.cms.gov/

18

Hospital Inpatient Likely MS-DRG Assignment MS-DRG10 MS-DRG Description Medicare National

Average Payment

2017

573 Skin Graft for Skin Ulcer or Cellulitis with MCC $21,988.40

574 Skin Graft for Skin Ulcer or Cellulitis with CC $17,036.95

575 Skin Graft for Skin Ulcer or Cellulitis without CC/MCC $8,821.12

622 Skin Grafts and Wound Debridement for Endocrine,

Nutritional and Metabolic Disorders with MCC

$21,952.62


Nutritional and Metabolic Disorders with CC

$11,300.72


Nutritional and Metabolic Disorders without CC/MCC

$6,394.00

Long-Term Acute Care Hospitals (LTCH)

Under the LTCH Prospective Payment System (PPS), patients are classified into

distinct diagnostic groups based on clinical characteristics and expected

resource utilization. The patient classification system groupings under the

Medicare-Severity-LTC-DRGs (MS-LTC-DRGs) are weighted to account for the

difference in resource consumption by LTCH patients. They have been

weighted to reflect the resources required to treat the type of medically

complex patients that are characteristic of LTCHs.

The MS-LTC-DRG system provides a similar structure as inpatient hospitalizations

utilizing the MS-DRG reimbursement system. MS-LTC-DRGs represent a

consolidated prospective payment for all services provided by the hospital

during the patient’s hospitalization, based on submitted claims data. With

limited exceptions, the payment is inclusive of all services, products, and

resources, regardless of the final cost to the hospital. MS-LTC-DRGs are

assigned for each hospital stay based on the patient diagnosis or diagnoses

and any procedures performed during the hospitalization.

The table below provides potential MS-LTC-DRG assignments for long-term

care hospitals when applying skin substitutes or DermaPure® for the treatment

of wounds. Medicare average rates are also provided.

10 2017 MS-DRG relative weight multiplied by 2017 rate per IPPS Final Rule, as calculated by MCRA, payment

rates will vary by facility. Calculation includes labor related, non-labor related and capital payment rates.

19

Long-Term Care Hospital Likely MS-LTC-DRG Assignment

MS-LTC-DRG11 MS-LTC-DRG Description

Medicare LTCH

Standard Federal

Prospective

Payment Rate

2017

573 Skin Graft for Skin Ulcer or Cellulitis with MCC $76,818.59

574 Skin Graft for Skin Ulcer or Cellulitis with CC $76,818.59

575 Skin Graft for Skin Ulcer or Cellulitis without CC/MCC $28,875.46


Nutritional and Metabolic Disorders with MCC $57,742.43

623

Skin Grafts and Wound Debridement for Endocrine,

Nutritional and Metabolic Disorders with CC

Disorders with CC

$43,393.90

624

Skin Grafts and Wound Debridement for Endocrine,

Nutritional and Metabolic Disorders without

CC/MCC

$21,272.19









4. Documentation Support

Documentation of a patient’s history, conservative therapies and reason for

any service or procedure is the key to a positive reimbursement scenario.

When a skin substitute graft procedure is indicated by the physician, the

patient’s medical record should clearly state the reason for the procedure as

well as the outcomes and recommended therapies to follow. This

documentation will support claim review and pre-authorization alike. Follow-

up or staged procedures will depend on the initial documentation to support

medical necessity. The following general documentation guidelines should be

followed for all payors.

11 2017 MS-LTC-DRG relative weight multiplied by 2017 LTCH Standard Federal Prospective Payment Rate

www.cms.gov

http://www.cms.gov/

20

Clinical notes should contain the following details:

Reason for the procedure based on physical exam

All conservative therapies previously used in the treatment of the current

disease

Specific reason why this treatment is indicated for this patient

Anticipated outcomes

Recommended therapies or treatments

Operational notes might include the following:

History of patient encounters including conservative therapies

Current diagnosis or history of disease state

Details of findings on exam

Reason for procedure relevant to condition

Usual details of procedure

Explanation of technology specific to DermaPure®

Findings and any anticipated further treatments

A letter of medical necessity (LMN) may be required for pre-authorization of a

skin substitute graft procedure or for supporting documentation following a

request for a claim review. Details of the LMN should include the items on the

checklist above. An example LMN is provided in the following section of this

guide.

5. Pre-Authorization Overview

In order to facilitate coverage access for a proposed procedure, the physician

may request a pre-authorization from the patient’s private insurance carrier.

Some health plans require pre-authorization for all surgical procedures.

Requesting pre-authorization may only involve a simple contact by the

physician’s office to verify benefits and acquire an approval number to submit

with the claim. Alternatively, pre-authorization may require that the physician

provide more substantive information about the case.

To prepare a pre-authorization request that requires additional information

beyond basic coding, the physician’s staff must provide technical information

21

about the procedure and the unique technology involved. The treating

physician must also establish the medical necessity for the procedure, as it

applies to the specific patient.

Typically, the pre-authorization process and/or appeal process may require

submitting some or all of the following documentation:

Patient clinical notes, including documentation of prior conservative care;

Supporting technical information in the form of the FDA registration letter,

peer-reviewed clinical literature, clinical trial information and other

available technical resources;

Description of the technology and its use in this patient’s case; and

Description of medical necessity of the procedure for the specific patient.

Stages of the Pre-Authorization Process:

•Verify benefits and submit clinical information and literature on device.

Initiate Pre-Authorization

•Opportunity for the treating physician to discuss the medical necessity of the case with a Medical Director at the health plan.

Peer to Peer

•Expedited/Standard - Opportunity to request a Medical Director that did not review the initial submission. There may be one or two levels of internal appeals.

1st Level Appeal

•Expedited/Standard - Opportunity to request a Medical Director that did not review the initial submission as well as the peer to peer.

2nd Level Appeal

•Following appeal denial at all available internal levels, the patient should pursue an External Appeal with the applicable State Department of Insurance.

External Appeal

22

5.1 Pre-Authorization / Letter of Medical

Necessity

Providers, please note: Coverage requirements will typically vary by payor.

Therefore, physicians may seek pre-authorization for the procedure, during

which time health plans will determine whether the procedure is covered as

described in the pre-authorization submission. This sample letter includes

technical information regarding the on-label, approved use of the

DermaPure® skin substitute technology per the product instructions for use.

This template and the information provided herein are intended to provide

context for the procedure and related coding. Providers should select the

procedure, diagnosis, and technology coding that best represents each

patient’s medical condition and treatment and should reflect the services and

products that are medically necessary for the treatment of that patient.

Providers must ensure that all statements made to insurance carriers are true

and correct.

23

[Site Letterhead]

[DATE]

NAME OF INSURANCE COMPANY

ATTN:

FAX #:

RE: [PATIENT NAME]

[INSURANCE IDENTIFICATION NUMBER]

[REFERENCE #:]

[PRIMARY CPT CODE:]

[PRIMARY DX:]

Dear Utilization Review Manager:

On behalf of my patient, [PATIENT NAME], this letter serves as a pre-authorization request

and provides clinical information on this patient’s condition. It also serves as a formal

request for coverage by [INSURANCE COMPANY] for the medically necessary health

care services captioned above. This letter and its supporting documents will provide you

with a better depiction of this patient’s clinical history and this patient’s need for the

[DERMAPURE® SKIN SUBSTITUTE GRAFT PROCEDURE] It is my sincere hope that this

additional information will inform your decision to approve this surgery.

[INSERT PATIENT’S NAME] presented to me with [DESCRIBE SYMPTOMS WITH SPECIFICITY].

[MR/MS NAME]’s symptoms are exacerbated by: [DESCRIBE]

Description of Procedure: [PHYSICIAN INSERTS DETAILED PROCEDURE DESCRIPTION

INCLUDING THE USE OF THE DERMAPURE® SKIN SUBSTITUTE GRAFT]

Skin Substitute Description: DermaPure® is a decellularized dermal skin allograft produced

from split thickness skin grafts (which comprise the epidermis and upper part of the

dermis) retrieved from deceased tissue donors. All epidermal and cellular components

from the dermis are removed in a patented sequential decellularization process. The

donated split skin grafts undergo a multi-step process that removes the epidermis and

any donor cells and cell remnants from the graft, a procedure known as decellularization.

The particular decellularization procedure used is done by a patented method, dCELL®

Technology, that was developed by scientists at the University of Leeds.

The dCELL Technology process enables effective removal of up to 99% DNA from donor

tissue. The scaffold retains the essential structures of normal skin, including vascular

channels and a basement membrane which is essential for regeneration of the

24

epidermis. These structures can only be replicated in a graft material which is prepared

from donated human dermis tissue. Peer reviewed published research provides

evidence that when utilizing DermaPure® within 7 days there is evidence of native cells

key to healing the wound (endothelial cells and fibroblasts) present in the wound bed.

Additional published evidence shows that by day 21 there is a statistically significant

increase in proangiogenic factors such as PROK2, MT6-MMP and CD31. All of these

factors are important to closing the patient’s wound. In many instances only one

application of DermaPure® is necessary.

DermaPure® 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, subject

to Section 361 of the Public Health Service Act and 21 CFR 1270 and 1271.

Patient’s Clinical Need for the DermaPure® Skin substitute Graft Procedure: [PATIENT

NAME] is a [AGE] [GENDER] who presented to me with [DESCRIBE SYMPTOMS WITH

SPECIFICITY]. Prior treatments have included [DESCRIBE CONSERVATIVE CARE, USE OF

MEDICATIONS, PRIOR TREATMENTS, and PHYSICAL AIDS].

In a discussion with [INSERT MR./MS.] following an exam, a decision was made to move

forward with a skin substitute graft procedure.

I have attached the FDA registration letter for [DERMAPURE® DECELLULARIZED DERMAL

ALLOGRAFT] and the DermaPure® Technical Monograph. Should you have further

questions or concerns, please do not hesitate to call me at [INSERT PHYSICIAN TELEPHONE

NUMBER]. Thank you for your immediate attention and anticipated authorization of these

services for your insured.

Sincerely,

[PHYSICIAN NAME], [DEGREE]

25

6. Plan Denial Appeal Process Overview

When a third party health plan denies a procedure in accordance with their

medical policy guidelines, there is a process available to appeal that decision.

Insurance carriers provide this check and balance to allow for reconsideration

of the decision per their plan provisions and applicable state regulations. The

process will vary depending on the plan and regulatory requirements;

however, there are basic steps that can assist the provider in appealing the

initial denial.

To present an effective appeal, follow these steps:

1. Carefully review the denial reason and understand the specific health

plan’s policy;

2. Write an appeal letter clearly addressing the specific denial reasons;

3. Provide supporting information including product details and FDA

registration; and

4. Submit the appeal on time.

The following additional considerations may be helpful:

1. If the health plan is self-funded (employer based), patients can contact

their Human Resources (HR) department to assist in the patient’s appeal of

the decision. HR departments may have contacts within the health plan

that can provide helpful support.

2. The patient can contact the health plan directly and is the policy-holder

with an influence on the decision.

3. There are multiple steps in the appeal process and providers and patients

may exercise these rights according to their third party payor and state

guidelines.

26

Writing the Appeal Letter

When appealing a denial, the first step is often composing a letter to the health

plan that initially reviewed the case. This letter is submitted by the provider on

behalf of the patient, with the patient’s approval, and should outline the

reasons the denial should be overturned.

Detailed information regarding the denial reason should be prepared utilizing

the case specific information in the denial, as well as the more general

technology specific information and supporting clinical literature.

First, collect all the information required to support the appeal:

Denial letter

Health plan contracts and provider agreements

Applicable medical policy guidelines from the health plan (website access

is often a good resource for general policy)

Literature supporting the technology

FDA registration letter

Safety and effectiveness documentation

Peer-reviewed literature references (when available)

In drafting an appeal letter, consider the following:

Did the reviewer miss information about the technology?

Did the reviewer overlook a case specific detail?

Does the health plan clearly understand the procedure?

Was the information provided about the case correctly submitted?

Review the plan’s official policy online for more detailed understanding of

the denial reason

Be mindful of details, including:

Patient’s name

Subscriber’s name

Policy number

Description of exact service denied

Date denied

27

7. Resources for DermaPure® Technology

Support

The following resources can provide support when preparing a pre-

authorization for the DermaPure® skin substitute graft procedure when

performed in the office, outpatient or surgery center setting of care.

Complete understanding of the product, FDA registration, and directions for

use can provide a payor with the information they need to review and

approve a procedure.

These resources have been referenced in this guide and can be utilized when

required. They can be accessed in the accompanying Tool Kit.

FDA Registration Letter (DermaPure® was registered with the FDA as a human tissue product on

December 1, 2014)

Instructions for Use (IFU)

DermaPure® Technical Monograph

8. Coverage Summaries

General Coverage Policies (Commercial Health Plans, Medicare)12. Coverage

defines what medical technologies, services and procedures a health plan will

reimburse, and generally varies by payor. Private health plans, as well as

Medicare, may vary in their consideration of coverage for a particular

technology or procedure. Further, the patient’s individual benefit plan will

delineate what items and services may be covered by the health plan.

Absent the existence of a National Coverage Determination (NCD) or Local

Coverage Determination (LCD) related to a particular technology, Medicare

generally covers procedures and services that are considered reasonable and

necessary. The Centers for Medicare & Medicaid Services (CMS) has not issued

any NCDs addressing the application of human tissue products for wound

care. However, each of the eight regional Medicare Administrative

Contractors (MACs) may maintain an LCD or guideline related to the

application of skin substitutes for wound care.

These LCDs are largely restrictive, with only MACs (Novitas and CGS), allowing

coverage for DermaPure® in a written LCD specific to skin substitutes. First

12 LCDs and Medical Policies accessed 12/14/16. These policies are subject to review and can change without

notice.

28

Coast and Palmetto detail coverage eligibility and documentation

requirements for a case to be considered medically necessary and

appropriate. Noridian, NGS and WPS currently do not maintain a stand-alone

skin substitute LCD, nor does it list any skin substitute Q codes in its Non-Covered

Services LCD. In fact, Noridian recently removed all Q codes denoting skin

substitute products from its Non-Covered Services LCD. Consequently,

Noridian has decided, at least for the short term, to allow coverage for those

products with a HCPCS code in the Q4xxx range. Noridian, NGS and WPS allow

utilization of skin substitutes as long as it is medically reasonable and necessary.

MAC LCD Coverage for DermaPure® Novitas Palmetto NGS WPS CGS Noridian Cahaba First Coast

Covered Covered Covered Covered Covered Covered Not

Covered Covered

Private health plans maintain medical policies outlining coverage parameters

and restrictions for various human tissue products. DermaPure® is currently

listed as non-covered by several national and regional private health plans.

Aetna, Cigna, Humana, Anthem and Highmark list DermaPure® as an

experimental and investigational product however providers have obtained

coverage for DermaPure® in case by case scenarios despite DermaPure®

being listed as non-covered. United Healthcare and BlueCross & BlueShield

HCSC do not maintain current medical policies for skin substitutes.

Please check and confirm your insurer’s specific medical policies and pre-

authorization guidelines to help facilitate the attainment of coverage. Note

that the coverage information above is for informational use. It is the provider’s

and patient’s responsibility to verify coverage based upon the patient’s health

plan and individual plan benefit. Even where medical policies may deny

separate reimbursement for DermaPure®, it may still be possible to obtain

reimbursement on a case by case basis through utilization of the health plan’s

pre-authorization process.

General guidance regarding this pre-authorization process, including

documentation required as well as instructions for handling subsequent claim

denials and appeals, is provided in the Resource Guide. Pre-authorization

signifies that the health plan has given a general approval of treatment for the

patient before the procedure has actually occurred. Final approval and

reimbursement is only given after claim submittal and at the time of

adjudication by the health plan.

29

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