MEDICAL POLICY 7.01.78

Autografts and Allografts in the Treatment of Focal

Articular Cartilage Lesions

BCBSA Ref. Policy: 7.01.78*

Effective Date: July 1, 2018

Last Revised: June 22, 2018

Replaces: N/A

RELATED MEDICAL POLICIES:

7.01.48 Autologous Chondrocyte Implantation for Focal Articular Cartilage

Lesions

11.01.524 Site of Service: Select Surgical Procedures

Select a hyperlink below to be directed to that section.

POLICY CRITERIA | CODING | RELATED INFORMATION

EVIDENCE REVIEW | REFERENCES | HISTORY

Clicking this icon returns you to the hyperlinks menu above.

Introduction

Cartilage is tissue that covers the ends of bones where they come together to form joints.

Cartilage allows the ends of the bones to move comfortably across each other as a joint flexes

or rotates. A focal articular cartilage lesion is an area of damage to cartilage and possibly the

bone beneath it. When cartilage is damaged, over time it can deteriorate to the point where all

of the cartilage is worn away and the bone beneath is affected. This is known as a full thickness

defect. Grafting a small amount of bone and cartilage is one way to treat severe or large areas of

damage. The graft material can be taken from a persons own tissue (this is known as an

autograft) or from donor tissue (allograft). This policy discusses when cartilage grafting may be

considered medically necessary. There are a number of other methods of using cartilage tissue

to repair damage. This includes cutting cartilage into tiny pieces and placing it over the

damaged area. These and other similar techniques are unproven and not covered.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The

rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for

providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can

be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a

service may be covered.

https://www.premera.com/medicalpolicies/7.01.48.pdfhttps://www.premera.com/medicalpolicies/7.01.48.pdfhttps://www.premera.com/medicalpolicies/11.01.524.pdf

Page | 2 of 21

Policy Coverage Criteria

Site of service is defined as the location where the surgical procedure is performed, such as an

off campus-outpatient hospital or medical center, an on campus-outpatient hospital or medical

center, an ambulatory surgical center, or an inpatient hospital or medical center.

Site of Service for

Elective Surgical

Procedures

Medical Necessity

Medically necessary sites

of service:

Off campus-outpatient

hospital/medical center

On campus-outpatient

hospital/medical center

Ambulatory Surgical

Center

Certain elective surgical procedures will be covered in the most

appropriate, safe, and cost effective site. These are the

preferred medically necessary sites of service for certain

elective surgical procedures.

Inpatient hospital/medical

center

Certain elective surgical procedures will be covered in the most

appropriate, safe, and cost-effective site. This site is

considered medically necessary only when the patient has a

clinical condition which puts him or her at increased risk for

complications including any of the following (this list may not

be all inclusive):

Anesthesia Risk

o ASA classification III or higher (see definition)

o Personal history of complication of anesthesia

o Documentation of alcohol dependence or history of

cocaine use

o Prolonged surgery (>3 hours)

Cardiovascular Risk

o Uncompensated chronic heart failure (NYHA class III or IV)

o Recent history of myocardial infarction (MI) (

Page | 3 of 21

Site of Service for

Elective Surgical

Procedures

Medical Necessity

o Symptomatic cardiac arrhythmia despite medication

o Significant valvular heart disease

Liver Risk

o Advance liver disease (MELD Score > 8)**

Pulmonary Risk

o Chronic obstructive pulmonary disease (COPD) (FEV1

Page | 4 of 21

Treatment Medical Necessity Other cartilage repair techniques are inadequate due to lesion

size, location, or depth such as:

o Microfracture

o Osteochondral autografting

Osteochondral allografting may be considered medically

necessary for treating the ankle when the following criteria are

met:

Osteochondral lesions of the talus are large (area >1.5 cm2) or

cystic (volume >3.0 cm3)

AND

Autografting is inadequate due to lesion size, depth, or

location.

OR

Revision surgery is needed for osteochondral lesions that are

large (area >1.5 cm2) or cystic (volume >3.0 cm3):

o After failed prior marrow stimulation

o When autografting is inadequate due to lesion size, depth

or location

Osteochondral allografting for all other joints is considered

investigational.

Osteochondral

autografting

Osteochondral autografting may be considered medically

necessary for treating cartilage defects of the knee when ALL

of the following criteria are met:

Adolescent patients should be skeletally mature with

documented closure of growth plates (eg, 15 years or older)

Adult patients that are considered an unsuitable candidate for

total knee replacement (eg, younger than 55 years of age)

Presence of debilitating symptoms that significantly limit

ambulation

Failed conventional medical treatment (including physical

therapy and/or bracing techniques) and/or prior surgical

treatment

Body mass-index (BMI) is 35 kg/m or less

Symptomatic focal full-thickness articular cartilage defect is

present

Focal, full-thickness (grade III or IV) unipolar lesions of the or

Page | 5 of 21

Treatment Medical Necessity on the weight-bearing surface of the femoral condyles,

trochlea, or patella between 1.0 and 2.5 cm2 in size

Minimal to absent degenerative changes in the surrounding

articular cartilage (Outerbridge grade II or less, see table

below)

Normal knee alignment and stability or correctable varus or

valgus deformities achieved concurrently at the time of the

procedure

Osteochondral autografting may be considered medically

necessary for treating the ankle when the following criteria are

met:

Osteochondral lesions of the talus are large (area >1.5 cm2) or

cystic (volume >3.0 cm3)

Revision surgery is needed for an osteochondral lesion of the

talus after failed marrow stimulation

Osteochondral autografting for all other joints and any

indications other than those listed above is considered

investigational.

Treatment Investigational Treatment of focal

articular lesions

Treatment of focal articular cartilage lesions with any of the

following is considered investigational:

Autologous minced or particulated cartilage

Allogeneic minced or particulated cartilage

Decellularized osteochondral allograft plugs (eg, Chondrofix)

Reduced osteochondral allograft discs (eg, ProChondrix,

Cartiform)

Additional Information If dbridement is the only prior surgical treatment, consideration should be given to marrow-

stimulating techniques before osteochondral grafting is performed, particularly for lesions less

than 1.5 cm2 in area or 3.0 cm3 in volume.

Page | 6 of 21

Additional Information Severe obesity (eg, body mass index >35 kg/m2) may affect outcomes due to the increased

stress on weight-bearing surfaces of the joint.

Misalignment and instability of the joint are contraindications. Therefore, additional

procedures, such as repair of ligaments or tendons or creation of an osteotomy for

realignment of the joint, may be performed at the same time. In addition, meniscal allograft

transplantation may be performed in combination, either concurrently or sequentially, with

osteochondral allografting or osteochondral autografting.

Coding

Code Description

CPT 27415 Osteochondral allograft, knee, open

27416 Osteochondral autograft(s), knee, open (eg, mosaicplasty) (includes harvesting of

autograft[s])

28446 Open osteochondral autograft, talus (includes obtaining graft[s])

29866 Arthroscopy, knee, surgical; osteochondral autograft(s) (eg, mosaicplasty) (includes

harvesting of the autograft[s])

29867 Arthroscopy, knee, surgical; osteochondral allograft (eg, mosaicplasty)

Note: CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS

codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS).

Related Information

Definition of Terms

American Society of Anesthesiologists (ASA) Score:

ASA 1 A normal healthy patient.

ASA 2 A patient with mild systemic disease.

Page | 7 of 21

ASA 3 A patient with severe systemic disease.

ASA 4 A patient with severe systemic disease that is a constant threat to life.

ASA 5 A moribund patient who is not expected to survive

New York Heart Association (NYHA) Classification:

Class I No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath

when walking, climbing stairs etc.

Class II Mild symptoms (mild shortness of breath and/or angina) and slight limitation during

ordinary activity.

Class III Marked limitation in activity due to symptoms, even during less-than-ordinary

activity, eg, walking short distances (20100 m).Comfortable only at rest.

Class IV Severe limitations. Experiences symptoms even while at rest. Mostly bedbound

patients

Outerbridge Classification

Grade Pathology

0 Normal cartilage

I Softening and swelling of articular cartilage

II Fragmentation and fissuring of articular cartilage affecting an area of less than 0.5 inches

III Fragmentation and fissuring of articular cartilage affecting an area of greater than 0.5 inches

IV Cartilage erosion to bone

Evidence Review

Description

Osteochondral grafts are used to repair full-thickness chondral defects involving a joint. In the

case of osteochondral autografts, one or more small osteochondral plugs are harvested from

non-weight-bearing sites, usually from the knee, and press fit into a prepared site in the lesion.

Osteochondral allografts are typically used for larger lesions. Autologous or allogeneic minced

cartilage, decellularized osteochondral allograft plugs, and reduced osteochondral allograft discs

are also being evaluated as a treatment of articular cartilage lesions.

Page | 8 of 21

Background

Articular Cartilage Lesions

Damaged articular cartilage can be associated with pain, loss of function, and disability, and can

lead to debilitating osteoarthrosis over time. These manifestations can severely impair an

individuals activities of daily living and quality of life. The vast majority of osteochondral lesions

occur in the knee with the talar dome and capitulum being the next most frequent sites. The

most common locations of lesions are the medial femoral condyle (69%), followed by the

weight-bearing portion of the lateral femoral condyle (15%), the patella (5%), and trochlear

fossa.1 Talar lesions are reported to be about 4% of osteochondral lesions.2

Treatment

There are 2 main goals of conventional therapy for patients who have significant focal defects of

the articular cartilage: symptom relief and articular surface restoration.

First, there are procedures intended primarily to achieve symptomatic relief: dbridement

(removal of debris and diseased cartilage) and rehabilitation. Second, there are procedures

intended to restore the articular surface. Treatments may be targeted to the focal cartilage

lesion, and most such treatments induce local bleeding, fibrin clot formation, and resultant

fibrocartilage growth. These marrow stimulation procedures include microfracture, abrasion

arthroplasty, and drilling, all of which are considered standard therapies.

Microfracture

Efficacy of the microfracture technique for articular cartilage lesions of the knee was examined

by Mithoefer et al (2009) in systematic review.3 Twenty-eight studies (total N=3122 patients)

were selected; 6 studies were randomized controlled trials (RCTs). Microfracture was found to

improve knee function in all studies during the first 24 months after the procedure, but the

reports on durability were conflicting. A prospective longitudinal study of 110 patients by

Solheim et al (2016) found that, at a mean of 12 years (range, 10-14 years) after microfracture,

45.5% of patients had poor outcomes, including 43 patients who required additional surgery.4

The size of the lesion has also been shown to have an effect on outcomes following marrow

stimulation procedures.

Page | 9 of 21

Abrasion

Fibrocartilage is generally considered to be less durable and mechanically inferior to the original

articular cartilage. Thus, various strategies for chondral resurfacing with hyaline cartilage have

been investigated. Alternatively, treatments of very extensive and severe cartilage defects may

resort to complete replacement of the articular surface either by osteochondral allotransplant or

artificial knee replacement.

Osteochondral Grafting

Autologous or allogeneic grafts of osteochondral or chondral tissue have been proposed as

treatment alternatives for patients who have clinically significant, symptomatic, focal defects of

the articular cartilage. It is hypothesized that the implanted grafts chondrocytes retain features

of hyaline cartilage that is similar in composition and property to the original articulating surface

of the joint. If true, the restoration of a hyaline cartilage surface might restore the integrity of the

joint surface and promote long-term tissue repair, thereby improving function and delaying or

preventing further deterioration.

Both fresh and cryopreserved allogeneic osteochondral grafts have been used with some

success, although cryopreservation decreases the viability of cartilage cells, and fresh allografts

may be difficult to obtain and create concerns regarding infectious diseases. As a result,

autologous osteochondral grafts have been investigated as an option to increase the survival

rate of the grafted cartilage and to eliminate the risk of disease transmission. Autologous grafts

are limited by the small number of donor sites; thus, allografts are typically used for larger

lesions. In an effort to extend the amount of the available donor tissue, investigators have used

multiple, small osteochondral cores harvested from non-weight-bearing sites in the knee for

treatment of full-thickness chondral defects. Several systems are available for performing this

procedure: the Mosaicplasty System (Smith and Nephew), the OATS (Osteochondral Autograft

Transfer System; Arthrex), and the COR and COR2 systems (DePuy Mitek). Although

mosaicplasty and autologous osteochondral transplantation (AOT) may use different

instrumentation, the underlying mode of repair is similar (ie, use of multiple osteochondral cores

harvested from a non-weight-bearing region of the femoral condyle and autografted into the

chondral defect). These terms have been used interchangeably to describe the procedure.

Preparation of the chondral lesion involves dbridement and preparation of recipient tunnels.

Multiple individual osteochondral cores are harvested from the donor site, typically from a

peripheral non-weight-bearing area of the femoral condyle. Donor plugs range from 6 to 10 mm

Page | 10 of 21

in diameter. The grafts are press fit into the lesion in a mosaic-like fashion into the same-sized

tunnels. The resultant surface consists of transplanted hyaline articular cartilage and

fibrocartilage, which is thought to provide grouting between the individual autografts.

Mosaicplasty or AOT may be performed with either an open approach or arthroscopically.

Osteochondral autografting has also been investigated as a treatment of unstable

osteochondritis dissecans lesions using multiple dowel grafts to secure the fragment. While

osteochondral autografting is primarily performed on the femoral condyles of the knee,

osteochondral grafts have been used to repair chondral defects of the patella, tibia, and ankle.

With osteochondral autografting, the harvesting and transplantation can be performed during

the same surgical procedure. Technical limitations of osteochondral autografting are difficulty in

restoring concave or convex articular surfaces, incongruity of articular surfaces that can alter

joint contact pressures, short-term fixation strength and load-bearing capacity, donor-site

morbidity, and lack of peripheral integration with peripheral chondrocyte death.

Reddy et al (2007) evaluated donor-site morbidity in 11 of 15 patients who had undergone graft

harvest from the knee (mean, 2.9 plugs) for treatment of osteochondral lesions of the talus.5 At

an average 47-month follow-up (range, 7-77 months), 5 patients were rated as having an

excellent Lysholm Knee Scale score (95-100 points), 2 as good (84-94 points), and 4 as poor

(64 points). The reported knee problems were instability in daily activities, pain after walking 1

mile or more, slight limp, and difficulty squatting. Hangody et al (2001) reported that some

patients had slight or moderate complaints with physical activity during the first postoperative

year, but there was no long-term donor-site pain in a series of 36 patients evaluated 2 to 7 years

after AOT.6

Filling defects with minced articular cartilage (autologous or allogeneic) is another single-stage

procedure being investigated for cartilage repair. The Cartilage Autograft Implantation System

(CAIS; Johnson & Johnson) harvests cartilage and disperses chondrocytes on a scaffold in a

single-stage treatment. The Reveille Cartilage Processor (Exactech Biologics) has a high-speed

blade and sieve to cut autologous cartilage into small particles for implantation. BioCartilage

(Arthrex) consists of a micronized allogeneic cartilage matrix that is intended to provide a

scaffold for microfracture. DeNovo NT Graft (Natural Tissue Graft) is produced by ISTO

Technologies and distributed by Zimmer. DeNovo NT consists of manually minced cartilage

tissue pieces obtained from juvenile allograft donor joints. The tissue fragments are mixed

intraoperatively with fibrin glue before implantation in the prepared lesion. It is thought that

mincing the tissue helps both with cell migration from the extracellular matrix and with fixation.

A minimally processed osteochondral allograft (Chondrofix; Zimmer) is now available.

Chondrofix is composed of decellularized hyaline cartilage and cancellous bone and can be used

Page | 11 of 21

off the shelf with precut cylinders (7-15 mm). Multiple cylinders may be used to fill a larger

defect in a manner similar to AOT or mosaicplasty.

ProChondrix (AlloSource) and Cartiform (Arthrex) are wafer-thin allografts where the bony

portion of the allograft is reduced. The discs are laser etched or porated and contain hyaline

cartilage with chondrocytes, growth factors, and extracellular matrix proteins. ProChondrix is

available in dimensions from 7 to 20 mm and is stored fresh for a maximum of 28 days.

Cartiform is cut to the desired size and shape and is stored frozen for a maximum of 2 years. The

osteochondral discs are typically inserted after microfracture and secured in place with fibrin

glue and/or sutures.

Autologous chondrocyte implantation is another method of cartilage repair involving the

harvesting of normal chondrocytes from normal non-weight-bearing articular surfaces, which

are then cultured and expanded in vitro and implanted back into the chondral defect.

Autologous chondrocyte implantation techniques are discussed in in a separate medical policy

(see Related Policies).

Summary of Evidence

Knee Lesions

For individuals who have full-thickness articular cartilage lesions of the knee who receive an

osteochondral autograft, the evidence includes randomized controlled trials (RCTs), systematic

reviews of RCTs, and longer term observational studies. Relevant outcomes are symptoms,

functional outcomes, quality of life, and treatment-related morbidity. Several systematic reviews

have evaluated osteochondral autografting for cartilage repair in the short and mid-term.

Compared with abrasion techniques (eg, microfracture, drilling), there is evidence that

osteochondral autografting decreases failure rates and improves outcomes in patients with

medium-size lesions (eg, 2-6 cm2) when measured at longer follow-up. This is believed to be

due to the higher durability of hyaline cartilage compared with fibrocartilage from abrasion

techniques. There appears to be a relatively narrow range of lesion size for which osteochondral

autografting is most effective. The best results have also been observed with lesions on the

femoral condyles, although treatment of lesions on the trochlea and patella may also improve

outcomes. Correction of malalignment is important for success of the procedure. The evidence

suggests that osteochondral autografts may be considered an option for moderate-sized

symptomatic full-thickness chondral lesions of the femoral condyle, trochlea, or patella. The

evidence is sufficient to determine that the technology results in a meaningful improvement in

the net health outcome.

Page | 12 of 21

For individuals who have full-thickness articular cartilage lesions of the knee when autografting

would be inadequate due to lesion size, location, or depth who receive fresh osteochondral

allografts, the evidence includes case series. Relevant outcomes are symptoms, functional

outcomes, quality of life, and treatment-related morbidity. Due to the lack of alternatives, this

procedure may be considered a salvage operation in younger patients for full-thickness

chondral defects of the knee caused by acute or repetitive trauma when other cartilage repair

techniques (eg, microfracture, osteochondral autografting, ACI [autologous chondrocyte

implantation]) would be inadequate due to lesion size, location, or depth. The evidence is

sufficient to determine that the technology results in a meaningful improvement in the net

health outcome.

Ankle Lesions

For individuals who have primary full-thickness articular cartilage lesions of the ankle less than

1.5 cm2 who receive an osteochondral autograft, the evidence includes observational studies

and a systematic review of these studies. Relevant outcomes are symptoms, functional

outcomes, quality of life, and treatment-related morbidity. A systematic review found similar

improvements in outcomes following microfracture and autologous osteochondral

transplantation (AOT). Given the success of marrow stimulation procedures for smaller lesions

(1.5 cm2) or cystic (volume >3.0 cm3) full-thickness articular

cartilage lesions of the ankle who receive an osteochondral autograft, the evidence includes an

RCT and 2 observational studies. Relevant outcomes are symptoms, functional outcomes, quality

of life, and treatment-related morbidity. An RCT in patients with large lesions found similar

efficacy for AOT, marrow stimulation, and arthroplasty at 2-year follow-up. Longer term results

were not reported. Because observational studies of marrow stimulation in the talus have

generally reported worse outcomes and high failure rates for large lesions, there is a strong

rationale for using autografts. However, there is limited evidence that osteochondral autografts

lead to better outcomes than microfracture at longer follow-up. The strongest evidence is

derived from an observational study that showed good improvement on the Foot and Ankle

Outcome Score through at least 5-year follow-up using AOT in both larger (2 plugs) and smaller

(1 plug) lesions. Additional study is needed to evaluate the durability of AOT in larger lesions.

The evidence is insufficient to determine the effects of the technology on health outcomes.

Page | 13 of 21

For individuals who have osteochondral lesions of the ankle that have failed primary treatment

who receive an osteochondral autograft, the evidence includes 2 nonrandomized comparative

trials and case series. Relevant outcomes are symptoms, functional outcomes, quality of life, and

treatment-related morbidity. The best evidence for revision AOT comes from a nonrandomized

comparative study that found better outcomes with AOT than with repeat marrow stimulation.

This finding is supported by case series that have indicated good-to-excellent results at mid-

term and longer term follow-up with revision AOT. The evidence is sufficient to determine that

the technology results in a meaningful improvement in the net health outcome.

For individuals who have primary full-thickness articular cartilage lesions of the ankle less than

1.5 cm2 who receive a fresh osteochondral allograft, there is little evidence. Relevant outcomes

are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Because

microfracture is effective as a primary treatment for lesions less than 1.5 cm2 and AOT is

effective as a revision procedure, use of allograft for small primary cartilage lesions has not been

reported. The evidence is insufficient to determine the effects of the technology on health

outcomes.

For individuals who have large (area >1.5 cm2) or cystic (volume >3.0 cm3) cartilage lesions of

the ankle when autografting would be inadequate who receive a fresh osteochondral allograft,

the evidence includes a small number of patients in an RCT, case series, and a systematic review

of case series. Relevant outcomes are symptoms, functional outcomes, quality of life, and

treatment-related morbidity. The systematic review found a significant failure rate with

osteochondral allografts for talar lesions. Although there is a potential to delay or avoid

arthrodesis or total ankle arthroplasty in younger patients, use of an allograft may be

detrimental to future treatments. Additional study is needed. The evidence is insufficient to

determine the effects of the technology on health outcomes.

For individuals who have revision osteochondral lesions of the ankle when autografting would

be inadequate who receive a fresh osteochondral allograft, the evidence includes an RCT.

Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related

morbidity. The RCT found that outcomes were slightly, but not significantly, worse with

osteochondral allografts than with autografts. However, failure due to nonunion was higher in

the allograft group, consistent with other reports. The evidence is insufficient to determine the

effects of the technology on health outcomes.

Page | 14 of 21

Elbow Lesions

For individuals who have full-thickness articular cartilage lesions of the elbow who receive an

osteochondral autograft, the evidence includes a meta-analysis of case series. Relevant

outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity.

Osteochondritis dissecans of the elbow typically occurs in patients who play baseball or do

gymnastics. The literature on osteochondral autografts for advanced osteochondritis dissecans

of the elbow consists of small case series, primarily from Europe and Asia, and a systematic

review of case series. Although the meta-analysis suggested a benefit of osteochondral

autographs compared with dbridement or fixation, RCTs are needed to determine the effects of

the procedure with greater certainty. The evidence is insufficient to determine the effects of the

technology on health outcomes.

Shoulder Lesions

For individuals who have full-thickness articular cartilage lesions of the shoulder who receive an

osteochondral autograft, the evidence includes a case series. Relevant outcomes are symptoms,

functional outcomes, quality of life, and treatment-related morbidity. Evidence on osteochondral

autografting for the shoulder is very limited. The evidence is insufficient to determine the effects

of the technology on health outcomes.

Knee, Ankle, Elbow, or Shoulder Lesions Minced or Particulated Articular

Cartilage

For individuals who have full-thickness articular cartilage lesions of the knee, ankle, elbow, or

shoulder who receive autologous or allogeneic minced or particulated articular cartilage, the

evidence includes a small RCT and small case series. Relevant outcomes are symptoms,

functional outcomes, quality of life, and treatment-related morbidity. The evidence on

autologous minced cartilage includes a small RCT. The evidence on allogeneic juvenile minced

cartilage includes a few small case series. The case series have suggested an improvement in

outcomes compared with preoperative measures, but there is also evidence of subchondral

edema, nonhomogenous surface, graft hypertrophy, and delamination. For articular cartilage

lesions of the knee, further evidence, preferably from RCTs, is needed to evaluate the effect on

health outcomes compared with other procedures. There are fewer options for articular cartilage

lesions of the ankle. However, further study in a larger number of patients is needed to assess

Page | 15 of 21

the short- and long-term effectiveness of this technology. The evidence is insufficient to

determine the effects of the technology on health outcomes.

For individuals who have full-thickness articular cartilage lesions of the knee, ankle, elbow, or

shoulder who receive decellularized osteochondral allograft plugs or reduced osteochondral

allograft discs, the evidence includes small case series. Relevant outcomes are symptoms,

functional outcomes, quality of life, and treatment-related morbidity. The case series on

decellularized osteochondral allograft plugs reported delamination of the implants, and high

failure rates. Evidence on reduced osteochondral allograft discs consists only of case reports or

very small case series. The evidence is insufficient to determine the effects of the technology on

health outcomes.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 1.

Table 1. Summary of Key Trials

NCT No. Trial Name Planned

Enrollment

Completion

Date

Ongoing

NCT01347892a Post Market, Longitudinal Data Collection Study of Articular

Cartilage Lesions in the Ankle Treated With DeNovo(R) NT

205 Sep 2019

NCT01329445a Post Market, Longitudinal Data Collection Study of DeNovo

NT for Articular Cartilage Defects of the Knee

160 Dec 2021

NCT01670617a A Stratified, Post-Market Study of DeNovo NT for the

Treatment of Femoral and Patellar Articular Cartilage Lesions

of the Knee

90 Dec 2021

NCT: national clinical trial a Denotes industry-sponsored or cosponsored trial

Clinical Input Received from Physician Specialty Societies and Academic

Medical Centers

While the various physician specialty societies and academic medical centers may collaborate

with and make recommendations during this process, through the provision of appropriate

https://www.clinicaltrials.gov/ct2/show/NCT01347892?term=NCT01347892&rank=1https://www.clinicaltrials.gov/ct2/show/NCT01329445?term=NCT01329445&rank=1https://www.clinicaltrials.gov/ct2/show/NCT01670617?term=NCT01670617&rank=1

Page | 16 of 21

reviewers, input received does not represent an endorsement or position statement by the

physician specialty societies or academic medical centers, unless otherwise noted.

2017 Input

In response to requests, clinical input on osteochondral autografts improves for treating focal

articular cartilage lesions in the ankle and elbow was received from 3 respondents, including 2

specialty society-level response and 1 physician from 1 health systems, while this policy was

under review in 2017.

Based on the evidence and independent clinical input, the clinical input supports that the

following indications provide a clinically meaningful improvement in the net health outcome

and are consistent with generally accepted medical practice:

Use of osteochondral autograft for:

o Primary treatment of large (area >1.5 cm2) or cystic (volume >3.0 cm3) osteochondral

lesion of the talus.

o Revision surgery after failed marrow stimulation for osteochondral lesion of the talus.

Use of fresh osteochondral allograft for:

o Primary treatment of large (area >1.5 cm2) or cystic (volume >3.0 cm3) osteochondral

lesion of the talus when autografting would be inadequate due to lesion size, depth, or

location.

o Revision surgery for osteochondral lesions of the talus when autografting would be

inadequate due to lesion size, depth, or location.

Based on the evidence and independent clinical input, the clinical input does not support

whether the following indication provides a clinically meaningful improvement in the net health

outcome or is consistent with generally accepted medical practice.

Use of osteochondral grafts in the elbow.

Page | 17 of 21

2011 Input

In response to requests, input was received from 3 academic medical centers while this policy

was under review in 2011. Input generally agreed with the stated criteria for osteochondral

grafting, except the following: input was mixed on the requirement for an inadequate response

to a prior surgical procedure, the size of the lesion, and the requirement for an absence of

meniscal pathology. Input was also mixed on the investigational status of osteochondral grafts

in other joints, including the patellar and talar joints, and for the use of autologous minced

cartilage.

Practice Guidelines and Position Statements

American Academy of Orthopaedic Surgeons

In 2010 guidelines, which remain available on the American Academy of Orthopaedic Surgeons

website in 2018, on the diagnosis and treatment of osteochondritis dissecans, the Academy was

unable to recommend for or against a specific cartilage repair technique in symptomatic

skeletally immature or mature patients with an unsalvageable osteochondritis dissecans

lesion.48,49

A 2010 AAOS review of articular cartilage restoration methods stated that osteochondral

autografting is generally used for smaller focal lesions of the femoral condyle no greater than

1.5 to 2 cm.50

National Institute for Health and Care Excellence

The National Institute for Health and Care Excellence conducted a 2005 review of mosaicplasty

for knee cartilage defects. The corresponding guidance, released in 2006, stated that There is

some evidence of short-term efficacy, but data on long-term efficacy are inadequate.51

Medicare National Coverage

There is no national coverage determination (NCD). In the absence of an NCD, coverage

decisions are left to the discretion of local Medicare carriers.

Page | 18 of 21

Regulatory Status

The U. S. Food and Drug Administration regulates human cells and tissues intended for

implantation, transplantation, or infusion through the Center for Biologics Evaluation and

Research, under Code of Federal Regulation title 21, parts 1270 and 1271. Osteochondral grafts

are included in these regulations.

DeNovo ET Live Chondral Engineered Tissue Graft (Neocartilage) is marketed by ISTO

Technologies outside of the United States. The FDA approved ISTOs investigational new drug

application for Neocartilage in 2006, which allowed ISTO to pursue phase 3 clinical trials of the

product in human subjects. However, ISTOs clinical trial for Neocartilage was terminated due to

poor enrollment as of August 31, 2017.

References

1. Durur-Subasi I, Durur-Karakaya A, Yildirim OS. Osteochondral Lesions of Major Joints. Eurasian J Med. Jun 2015;47(2):138-144.

PMID 26180500

2. Freeland E, Dowd T. Osteochondral Lesions of the Talus. 2015;

http://www.aofas.org/PRC/conditions/Pages/Conditions/Osteochondral-Lesions-of-the-Talus.aspx. Accessed June 2018.

3. Mithoefer K, McAdams T, Williams RJ, et al. Clinical efficacy of the microfracture technique for articular cartilage repair in the

knee: an evidence-based systematic analysis. Am J Sports Med. Oct 2009;37(10):2053-2063. PMID 19251676

4. Solheim E, Hegna J, Inderhaug E, et al. Results at 10-14 years after microfracture treatment of articular cartilage defects in the

knee. Knee Surg Sports Traumatol Arthrosc. May 2016;24(5):1587-1593. PMID 25416965

5. Reddy S, Pedowitz DI, Parekh SG, et al. The morbidity associated with osteochondral harvest from asymptomatic knees for the

treatment of osteochondral lesions of the talus. Am J Sports Med. Jan 2007;35(1):80-85. PMID 16957009

6. Hangody L, Kish G, Modis L, et al. Mosaicplasty for the treatment of osteochondritis dissecans of the talus: two to seven year

results in 36 patients. Foot Ankle Int. Jul 2001;22(7):552-558. PMID 11503979

7. Gracitelli GC, Moraes VY, Franciozi CE, et al. Surgical interventions (microfracture, drilling, mosaicplasty, and allograft

transplantation) for treating isolated cartilage defects of the knee in adults. Cochrane Database Syst Rev. Sep 03

2016;9:CD010675. PMID 27590275

8. Magnussen RA, Dunn WR, Carey JL, et al. Treatment of focal articular cartilage defects in the knee: a systematic review. Clin

Orthop Relat Res. Apr 2008;466(4):952-962. PMID 18196358

9. Pareek A, Reardon PJ, Macalena JA, et al. Osteochondral autograft transfer versus microfracture in the knee: a meta-analysis of

prospective comparative studies at midterm. Arthroscopy. Oct 2016;32(10):2118-2130. PMID 27487736

10. Harris JD, Cavo M, Brophy R, et al. Biological knee reconstruction: a systematic review of combined meniscal allograft

transplantation and cartilage repair or restoration. Arthroscopy. Oct 26 2011;27(3):409-418. PMID 21030203

11. Hangody L, Kish G, Karpati Z, et al. Arthroscopic autogenous osteochondral mosaicplasty for the treatment of femoral condylar

articular defects. A preliminary report. Knee Surg Sports Traumatol Arthrosc. Jan 1997;5(4):262-267. PMID 9430578

http://www.aofas.org/PRC/conditions/Pages/Conditions/Osteochondral-Lesions-of-the-Talus.aspx

Page | 19 of 21

12. Hangody L, Kish G, Karpati Z, et al. Mosaicplasty for the treatment of articular cartilage defects: application in clinical practice.

Orthopedics. Jul 1998;21(7):751-756. PMID 9672912

13. Hangody L, Vasarhelyi G, Hangody LR, et al. Autologous osteochondral grafting--technique and long-term results. Injury. Apr

2008;39(Suppl 1):S32-39. PMID 18313470

14. Solheim E, Hegna J, Oyen J, et al. Osteochondral autografting (mosaicplasty) in articular cartilage defects in the knee: results at

5 to 9 years. Knee. Jan 2010;17(1):84-87. PMID 19666226

15. Solheim E, Hegna J, Oyen J, et al. Results at 10 to 14 years after osteochondral autografting (mosaicplasty) in articular cartilage

defects in the knee. Knee. Aug 2013;20(4):287-290. PMID 23482060

16. Marcacci M, Kon E, Delcogliano M, et al. Arthroscopic autologous osteochondral grafting for cartilage defects of the knee:

prospective study results at a minimum 7-year follow-up. Am J Sports Med. Dec 2007;35(12):2014-2021. PMID 17724094

17. Astur DC, Arliani GG, Binz M, et al. Autologous osteochondral transplantation for treating patellar chondral injuries: evaluation,

treatment, and outcomes of a two-year follow-up study. J Bone Joint Surg Am. May 21 2014;96(10):816-823. PMID 24875022

18. Nho SJ, Foo LF, Green DM, et al. Magnetic resonance imaging and clinical evaluation of patellar resurfacing with press-fit

osteochondral autograft plugs. Am J Sports Med. Jun 2008;36(6):1101-1109. PMID 18337357

19. De Caro F, Bisicchia S, Amendola A, et al. Large fresh osteochondral allografts of the knee: a systematic clinical and basic

science review of the literature. Arthroscopy. Apr 2015;31(4):757-765. PMID 25660010

20. Chui K, Jeys L, Snow M. Knee salvage procedures: The indications, techniques and outcomes of large osteochondral allografts.

World J Orthop. Apr 18 2015;6(3):340-350. PMID 25893177

21. Nielsen ES, McCauley JC, Pulido PA, et al. Return to sport and recreational activity after osteochondral allograft transplantation

in the knee. Am J Sports Med. Jun 2017;45(7):1608-1614. PMID 28375642

22. Gracitelli GC, Meric G, Briggs DT, et al. Fresh osteochondral allografts in the knee: comparison of primary transplantation versus

transplantation after failure of previous subchondral marrow stimulation. Am J Sports Med. Apr 2015;43(4):885-891. PMID

25817190

23. Zengerink M, Struijs PA, Tol JL, et al. Treatment of osteochondral lesions of the talus: a systematic review. Knee Surg Sports

Traumatol Arthrosc. Feb 2010;18(2):238-246. PMID 19859695

24. Gobbi A, Francisco RA, Lubowitz JH, et al. Osteochondral lesions of the talus: randomized controlled trial comparing

chondroplasty, microfracture, and osteochondral autograft transplantation. Arthroscopy. Oct 2006;22(10):1085-1092. PMID

17027406

25. Choi WJ, Park KK, Kim BS, et al. Osteochondral lesion of the talus: is there a critical defect size for poor outcome? Am J Sports

Med. Oct 2009;37(10):1974-1980. PMID 19654429

26. Chuckpaiwong B, Berkson EM, Theodore GH. Microfracture for osteochondral lesions of the ankle: outcome analysis and

outcome predictors of 105 cases. Arthroscopy. Jan 2008;24(1):106-112. PMID 18182210

27. Cuttica DJ, Smith WB, Hyer CF, et al. Osteochondral lesions of the talus: predictors of clinical outcome. Foot Ankle Int. Nov

2011;32(11):1045-1051. PMID 22338953

28. Ramponi L, Yasui Y, Murawski CD, et al. Lesion size is a predictor of clinical outcomes after bone marrow stimulation for

osteochondral lesions of the talus. Am J Sports Med. Jun 2017;45(7):1698-1705. PMID 27852595

29. Haleem AM, Ross KA, Smyth NA, et al. Double-plug autologous osteochondral transplantation shows equal functional

outcomes compared with single-plug procedures in lesions of the talar dome: a minimum 5-year clinical follow-up. Am J Sports

Med. Aug 2014;42(8):1888-1895. PMID 24948585

30. Yoon HS, Park YJ, Lee M, et al. Osteochondral autologous transplantation is superior to repeat arthroscopy for the treatment of

osteochondral lesions of the talus after failed primary arthroscopic treatment. Am J Sports Med. Aug 2014;42(8):1896-1903.

PMID 24907287

Page | 20 of 21

31. Imhoff AB, Paul J, Ottinger B, et al. Osteochondral transplantation of the talus: long-term clinical and magnetic resonance

imaging evaluation. Am J Sports Med. Jul 2011;39(7):1487-1493. PMID 21372316

32. Kreuz PC, Steinwachs M, Erggelet C, et al. Mosaicplasty with autogenous talar autograft for osteochondral lesions of the talus

after failed primary arthroscopic management: a prospective study with a 4-year follow-up. Am J Sports Med. Jan

2006;34(1):55-63. PMID 16157849

33. Georgiannos D, Bisbinas I, Badekas A. Osteochondral transplantation of autologous graft for the treatment of osteochondral

lesions of talus: 5- to 7-year follow-up. Knee Surg Sports Traumatol Arthrosc. Dec 2016;24(12):3722-3729. PMID 25326766

34. VanTienderen RJ, Dunn JC, Kusnezov N, et al. Osteochondral allograft transfer for treatment of osteochondral lesions of the

talus: a systematic review. Arthroscopy. Jan 2017;33(1):217-222. PMID 27546173

35. van Dijk CN. Editorial commentary: Bulk osteochondral talar grafts compromise future arthrodesis or prosthesis. Arthroscopy.

Jan 2017;33(1):223-224. PMID 28003071

36. Ahmad J, Jones K. Comparison of osteochondral autografts and allografts for treatment of recurrent or large talar

osteochondral lesions. Foot Ankle Int. Jan 2016;37(1):40-50. PMID 26333683

37. Westermann RW, Hancock KJ, Buckwalter JA, et al. Return to sport after operative management of osteochondritis dissecans of

the capitellum: a systematic review and meta-analysis. Orthop J Sports Med. Jun 2016;4(6):2325967116654651. PMID 27482526

38. Bexkens R, Ogink PT, Doornberg JN, et al. Donor-site morbidity after osteochondral autologous transplantation for

osteochondritis dissecans of the capitellum: a systematic review and meta-analysis. Knee Surg Sports Traumatol Arthrosc. Jul

2017;25(7):2237-2246. PMID 28391550

39. Kircher J, Patzer T, Magosch P, et al. Osteochondral autologous transplantation for the treatment of full-thickness cartilage

defects of the shoulder: results at nine years. J Bone Joint Surg Br. Apr 2009;91(4):499-503. PMID 19336811

40. Cole BJ, Farr J, Winalski CS, et al. Outcomes after a single-stage procedure for cell-based cartilage repair: a prospective clinical

safety trial with 2-year follow-up. Am J Sports Med. Jun 2011;39(6):1170-1179. PMID 21460066

41. Farr J, Tabet SK, Margerrison E, et al. Clinical, radiographic, and histological outcomes after cartilage repair with particulated

juvenile articular cartilage: a 2-year prospective study. Am J Sports Med. Apr 9 2014;42(6):1417-1425. PMID 24718790

42. Tompkins M, Hamann JC, Diduch DR, et al. Preliminary results of a novel single-stage cartilage restoration technique:

particulated juvenile articular cartilage allograft for chondral defects of the patella. Arthroscopy. Oct 2013;29(10):1661-1670.

PMID 23876608

43. Saltzman BM, Lin J, Lee S. Particulated juvenile articular cartilage allograft transplantation for osteochondral talar lesions.

Cartilage. Jan 2017;8(1):61-72. PMID 27994721

44. Bleazey S, Brigido SA. Reconstruction of complex osteochondral lesions of the talus with cylindrical sponge allograft and

particulate juvenile cartilage graft: provisional results with a short-term follow-up. Foot Ankle Spec. Oct 2012;5(5):300-305.

PMID 22935411

45. Coetzee JC, Giza E, Schon LC, et al. Treatment of osteochondral lesions of the talus with particulated juvenile cartilage. Foot

Ankle Int. Sep 2013;34(9):1205-1211. PMID 23576118

46. Farr J, Gracitelli GC, Shah N, et al. High failure rate of a decellularized osteochondral allograft for the treatment of cartilage

lesions. Am J Sports Med. Aug 2016;44(8):2015-2022. PMID 27179056

47. Johnson CC, Johnson DJ, Garcia GH, et al. High short-term failure rate associated with decellularized osteochondral allograft for

treatment of knee cartilage lesions. Arthroscopy. Dec 2017;33(12):2219-2227. PMID 28967543

48. American Academy of Orthopaedic Surgeons Diagnosis and Treatment of Osteochondritis Dissecans Work Group. The

diagnosis and treatment of osteochondritis dissecans: Guideline and evidence report. 2010, December 4;

http://www.aaos.org/research/guidelines/OCD_guideline.pdf. Accessed June 2018.

49. Chambers HG, Shea KG, Anderson AF, et al. American Academy of Orthopaedic Surgeons clinical practice guideline on: the

diagnosis and treatment of osteochondritis dissecans. J Bone Joint Surg Am. Jul 18 2012;94(14):1322-1324. PMID 22810404

http://www.aaos.org/research/guidelines/OCD_guideline.pdf

Page | 21 of 21

50. Trice ME, Bugbee WD, Greenwald AS, et al. Articular cartilage restoration: A review of currently available methods. 2010;

http://www.aaos.org/cc_files/aaosorg/research/committee/biologic/bi_se_2010.pdf. Accessed June 2018.

51. National Institute for Health and Care Excellence (NICE). Mosaicplasty for knee cartilage defects [IPG162]. 2006;

http://www.nice.org.uk/guidance/ipg162. Accessed June 2018.

History

Date Comments 11/01/17 New policy, approved October 10, 2017, effective February 2, 2018. Add to Surgery

section. This policy was previously archived under policy number 7.01.506, but it is

being reinstated. This service may be considered medically necessary when certain

criteria are met, considered investigational when not met. Policy outlines

investigational indications.

01/12/18 Minor edit, added Outerbridge Classification table.

03/01/18 Note added that this policy has been revised. Added link to revised policy that will

become effective June 1, 2018.

06/01/18 Minor update; removed note and link to updated policy. Surgery Site of Service criteria

becomes effective.

07/01/18 Annual Review, approved June 22, 2018. Policy updated with literature review through

February 2018; references 21, 38, and 47 added; some references removed. Or

particulated added to the investigational policy statements on minced cartilage. Other

minor editing to policy statements for clarity only. Added CPT code 29867.

Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The

Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and

local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review

and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit

booklet or contact a member service representative to determine coverage for a specific medical service or supply.

CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). 2018 Premera

All Rights Reserved.

Scope: Medical policies are systematically developed guidelines that serve as a resource for Company staff when

determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to

the limits and conditions of the member benefit plan. Members and their providers should consult the member

benefit booklet or contact a customer service representative to determine whether there are any benefit limitations

applicable to this service or supply. This medical policy does not apply to Medicare Advantage.

http://www.aaos.org/cc_files/aaosorg/research/committee/biologic/bi_se_2010.pdfhttp://www.nice.org.uk/guidance/ipg162

037338 (07-2016)

Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. Premera does not exclude people or treat them differently because of race, color, national origin, age, disability or sex. Premera: Provides free aids and services to people with disabilities to communicate

effectively with us, such as: Qualified sign language interpreters Written information in other formats (large print, audio, accessible

electronic formats, other formats) Provides free language services to people whose primary language is not

English, such as: Qualified interpreters Information written in other languages

If you need these services, contact the Civil Rights Coordinator. If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator - Complaints and Appeals PO Box 91102, Seattle, WA 98111 Toll free 855-332-4535, Fax 425-918-5592, TTY 800-842-5357 Email AppealsDepartmentInquiries@Premera.com You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: U.S. Department of Health and Human Services 200 Independence Avenue SW, Room 509F, HHH Building Washington, D.C. 20201, 1-800-368-1019, 800-537-7697 (TDD) Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html. Getting Help in Other Languages This Notice has Important Information. This notice may have important information about your application or coverage through Premera Blue Cross. There may be key dates in this notice. You may need to take action by certain deadlines to keep your health coverage or help with costs. You have the right to get this information and help in your language at no cost. Call 800-722-1471 (TTY: 800-842-5357). (Amharic): Premera Blue Cross 800-722-1471 (TTY: 800-842-5357)

:(Arabic) .

Premera Blue Cross. . . . (TTY: 800-842-5357) 1471-722-800

(Chinese): Premera Blue Cross

800-722-1471 (TTY: 800-842-5357)

Oromoo (Cushite): Beeksisni kun odeeffannoo barbaachisaa qaba. Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandaa. Guyyaawwan murteessaa taan beeksisa kana keessatti ilaalaa. Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandaa. Kaffaltii irraa bilisa haala taeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu. Lakkoofsa bilbilaa 800-722-1471 (TTY: 800-842-5357) tii bilbilaa. Franais (French): Cet avis a d'importantes informations. Cet avis peut avoir d'importantes informations sur votre demande ou la couverture par l'intermdiaire de Premera Blue Cross. Le prsent avis peut contenir des dates cls. Vous devrez peut-tre prendre des mesures par certains dlais pour maintenir votre couverture de sant ou d'aide avec les cots. Vous avez le droit d'obtenir cette information et de laide dans votre langue aucun cot. Appelez le 800-722-1471 (TTY: 800-842-5357). Kreyl ayisyen (Creole): Avi sila a gen Enfmasyon Enptan ladann. Avi sila a kapab genyen enfmasyon enptan konsnan aplikasyon w lan oswa konsnan kouvti asirans lan atrav Premera Blue Cross. Kapab genyen dat ki enptan nan avi sila a. Ou ka gen pou pran kk aksyon avan sten dat limit pou ka kenbe kouvti asirans sante w la oswa pou yo ka ede w avk depans yo. Se dwa w pou resevwa enfmasyon sa a ak asistans nan lang ou pale a, san ou pa gen pou peye pou sa. Rele nan 800-722-1471 (TTY: 800-842-5357). Deutsche (German): Diese Benachrichtigung enthlt wichtige Informationen. Diese Benachrichtigung enthlt unter Umstnden wichtige Informationen bezglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross. Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung. Sie knnten bis zu bestimmten Stichtagen handeln mssen, um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten. Sie haben das Recht, kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten. Rufen Sie an unter 800-722-1471 (TTY: 800-842-5357). Hmoob (Hmong): Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb. Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross. Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no. Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd. Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj. Hu rau 800-722-1471 (TTY: 800-842-5357). Iloko (Ilocano): Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion. Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross. Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar. Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos. Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo. Tumawag iti numero nga 800-722-1471 (TTY: 800-842-5357). Italiano (Italian): Questo avviso contiene informazioni importanti. Questo avviso pu contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross. Potrebbero esserci date chiave in questo avviso. Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione. Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente. Chiama 800-722-1471 (TTY: 800-842-5357).

(Japanese): Premera Blue Cross

800-722-1471 (TTY: 800-842-5357) (Korean): . Premera Blue Cross . . . . 800-722-1471 (TTY: 800-842-5357) . (Lao): . Premera Blue Cross. . . . 800-722-1471 (TTY: 800-842-5357). (Khmer):

Premera Blue Cross

800-722-1471 (TTY: 800-842-5357) (Punjabi): . Premera Blue Cross . . , , 800-722-1471 (TTY: 800-842-5357).

:(Farsi) .

. Premera Blue Cross .

. .

)800-842-5357 TTY( 800-722-1471 .

Polskie (Polish): To ogoszenie moe zawiera wane informacje. To ogoszenie moe zawiera wane informacje odnonie Pastwa wniosku lub zakresu wiadcze poprzez Premera Blue Cross. Prosimy zwrcic uwag na kluczowe daty, ktre mog by zawarte w tym ogoszeniu aby nie przekroczy terminw w przypadku utrzymania polisy ubezpieczeniowej lub pomocy zwizanej z kosztami. Macie Pastwo prawo do bezpatnej informacji we wasnym jzyku. Zadzwocie pod 800-722-1471 (TTY: 800-842-5357). Portugus (Portuguese): Este aviso contm informaes importantes. Este aviso poder conter informaes importantes a respeito de sua aplicao ou cobertura por meio do Premera Blue Cross. Podero existir datas importantes neste aviso. Talvez seja necessrio que voc tome providncias dentro de determinados prazos para manter sua cobertura de sade ou ajuda de custos. Voc tem o direito de obter esta informao e ajuda em seu idioma e sem custos. Ligue para 800-722-1471 (TTY: 800-842-5357).

Romn (Romanian): Prezenta notificare conine informaii importante. Aceast notificare poate conine informaii importante privind cererea sau acoperirea asigurrii dumneavoastre de sntate prin Premera Blue Cross. Pot exista date cheie n aceast notificare. Este posibil s fie nevoie s acionai pn la anumite termene limit pentru a v menine acoperirea asigurrii de sntate sau asistena privitoare la costuri. Avei dreptul de a obine gratuit aceste informaii i ajutor n limba dumneavoastr. Sunai la 800-722-1471 (TTY: 800-842-5357). P (Russian): . Premera Blue Cross. . , , . . 800-722-1471 (TTY: 800-842-5357). Faasamoa (Samoan): Atonu ua iai i lenei faasilasilaga ni faamatalaga e sili ona taua e tatau ona e malamalama i ai. O lenei faasilasilaga o se fesoasoani e faamatala atili i ai i le tulaga o le polokalame, Premera Blue Cross, ua e tau fia maua atu i ai. Faamolemole, ia e iloilo faalelei i aso faapitoa oloo iai i lenei faasilasilaga taua. Masalo o lea iai ni feau e tatau ona e faia ao lei aulia le aso ua taua i lenei faasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo oloo e iai i ai. Oloo iai iate oe le aia tatau e maua atu i lenei faasilasilaga ma lenei famatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe. Vili atu i le telefoni 800-722-1471 (TTY: 800-842-5357). Espaol (Spanish): Este Aviso contiene informacin importante. Es posible que este aviso contenga informacin importante acerca de su solicitud o cobertura a travs de Premera Blue Cross. Es posible que haya fechas clave en este aviso. Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura mdica o ayuda con los costos. Usted tiene derecho a recibir esta informacin y ayuda en su idioma sin costo alguno. Llame al 800-722-1471 (TTY: 800-842-5357). Tagalog (Tagalog): Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross. Maaaring may mga mahalagang petsa dito sa paunawa. Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos. May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos. Tumawag sa 800-722-1471 (TTY: 800-842-5357). (Thai): Premera Blue Cross 800-722-1471 (TTY: 800-842-5357) (Ukrainian): . Premera Blue Cross. , . , , . . 800-722-1471 (TTY: 800-842-5357). Ting Vit (Vietnamese): Thng bo ny cung cp thng tin quan trng. Thng bo ny c thng tin quan trng v n xin tham gia hoc hp ng bo him ca qu v qua chng trnh Premera Blue Cross. Xin xem ngy quan trng trong thng bo ny. Qu v c th phi thc hin theo thng bo ng trong thi hn duy tr bo him sc khe hoc c tr gip thm v chi ph. Qu v c quyn c bit thng tin ny v c tr gip bng ngn ng ca mnh min ph. Xin gi s 800-722-1471 (TTY: 800-842-5357).