HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
S-249-019
Topic:
Amniotic Membrane and Amniotic Fluid
Section:
Surgery
Effective Date:
April 1, 2024
Issued Date:
April 1, 2024
Last Revision Date:
March 2024
Annual Review:
June 2022
 
 

Human amniotic membrane (HAM) forms the innermost layer of the placenta and is harvested from the time of caesarean section. It is cleaned, sterilized and cryo-preserved or dehydrated and can be utilized to facilitate wound healing in diabetic and venous ulcers or sutured onto ocular surfaces.

Amniotic fluid contains a concentration of growth factors and nutrients that promote healing in soft-tissue repair of bone, tendon and cartilage, as well as reducing inflammation and pain, in conditions such as osteoarthritis and plantar fasciitis.

Policy Position

Treatment of nonhealing* diabetic lower-extremity ulcers using ANY of the following HAM products may be considered medically necessary:

  • Affinity®; or
  • AmnioBand® Membrane; or
  • Biovance®; or
  • Epifix®; or
  • Grafix™.

Note: Nonhealing is defined as less than a 20% decrease in wound area with standard wound care for at least two (2) weeks.

All other HAM products for the treatment of non-healing diabetic lower-extremity ulcers not meeting the criteria as indicated in this policy are considered experimental/investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Q4132

Q4133

Q4151

Q4154

Q4159

Q4168

Q4186




Treatment of non-healing venous stasis ulcers using Grafix may be considered medically necessary when BOTH of the following criteria are met:

  • Partial- or full-thickness venous stasis ulcer of greater than four (4) weeks duration for which standard wound therapy has failed; and
  • Treated lower extremity has adequate blood supply as evidenced by either the presence of a palpable pedal pulse or an ankle-brachial index (ABI) of greater than or equal to 0.70

When the above medical necessity criteria are met, the following conditions of coverage apply:

  • Treatment is limited to one (1) initial application
  • Additional applications at a minimum of (1) one week intervals, for up to a maximum of four (4) in 12 weeks are considered medically necessary when evidence of wound healing is present (e.g., signs of epithelialization and reduction in ulcer size)

Quantity of treatments that exceed the frequency guidelines listed in this policy are considered not medically necessary.

All other HAM products for the treatment of venous stasis ulcers not meeting the criteria as indicated in this policy are considered experimental/investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Q4133

 

 

 

 

 

 




Sutured human amniotic membrane HAM grafts may be considered medically necessary for the treatment of ANY of the following ophthalmic indications:

  • Neurotrophic keratitis; or
  • Corneal ulcers and melts; or
  • Pterygium repair; or
  • Stevens-Johnson syndrome; or
  • Persistent epithelial defects.*

Note: A persistent epithelial defect is one that failed to close completely after five (5) days of conservative treatment or has failed to demonstrate a decrease in size after two (2) days of conservative treatment. Conservative treatment is defined as use of topical lubricants and/or topical antibiotics and/or therapeutic contact lens and/or patching.

Sutured HAM grafts not meeting the criteria as indicated in this policy are considered experimental/investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

65779

Q4100

V2790

 

 

 

 

 




Human amniotic membrane (HAM) grafts without suture (Prokera®, AmbioDisk™) may be considered medically necessary for the treatment of the following ophthalmic indications:

  • Neurotrophic keratitis with ocular surface damage and inflammation that does not respond to conservative therapy; or
  •  Corneal ulcers and melts that do not respond to initial conservative therapy; or
  • Corneal perforation when there is active inflammation after corneal transplant requiring adjunctive treatment; or
  • Bullous keratopathy as a palliative measure in individuals who are not candidates for curative treatment (eg, endothelial or penetrating keratoplasty); or
  • Partial limbal stem cell deficiency with extensive diseased tissue where selective removal alone is not sufficient; or
  • Moderate or severe Stevens-Johnson syndrome; or
  • Persistent epithelial defects that do not respond within two (2) days to conservative therapy; or
  • Severe dry eye (DEWS 3 or 4) with ocular surface damage and inflammation that remains symptomatic after Steps 1, 2, and 3 of the dry eye disease management algorithm; or
  • Moderate or severe acute ocular chemical burn.

Human amniotic membrane without suture for ophthalmic indications not meeting the criteria as indicated in this policy is considered experimental/investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

65778

Q4100

 

 

 

 

 




All other HAM products not meeting the criteria as indicated in this policy are considered experimental/investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

A2022

A2023  

Q4137  

Q4138  

Q4140  

Q4148  

Q4150  

Q4153  

Q4157

Q4160  

Q4163  

Q4169  

Q4170  

Q4173  

Q4176

Q4178  

Q4180

Q4183  

Q4184  

Q4185  

Q4187  

Q4188

Q4189  

Q4190 

Q4191 

Q4192  

Q4194  

Q4195  

Q4198

Q4199  

Q4201  

Q4204  

Q4205

Q4208  

Q4209  

Q4210

Q4211  

Q4214  

Q4216  

Q4217  

Q4218

Q4219 

Q4221 

Q4224  

Q4225  

Q4227  

Q4229  

Q4230  

Q4231

Q4232

Q4233  

Q4234  

Q4235  

Q4236  

Q4237  

Q4239  

Q4240

Q4241

Q4242  

Q4245  

Q4246  

Q4247  

Q4248

Q4249  

Q4250

Q4251  

Q4252  

Q4253  

Q4254 

Q4255 

Q4256  

Q4257

Q4258  

Q4259   

Q4260  

Q4261  

Q4263  

Q4262

Q4264  

Q4265

Q4266  

Q4267  

Q4268

Q4269  

Q4270  

Q4271  

Q4272  

Q4273  

Q4274  

Q4275  

Q4276  

Q4277  

Q4278  

Q4279  

Q4280  

Q4281  

Q4282  

Q4283  

Q4284  

Q4285  

Q4286  

Q4287  

Q4288  

Q4289  

Q4290  

Q4291  

Q4292  

Q4293  

Q4294  

Q4295  

Q4296  

Q4297  

Q4298  

Q4299  

Q4300  

Q4301  

Q4302  

Q4303  

Q4304  

Q4305 

Q4306 

Q4307 

Q4308 

Q4309 

Q4310 

 




The following are considered experimental/investigational and, therefore, non-covered for all indications because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature:

  • Injection of micronized or particulated human amniotic membrane; and
  • Injection of human amniotic fluid.

Q4100

Q4139

Q4145

Q4155

Q4162

Q4171

Q4174

Q4177

Q4206

Q4212

Q4213

Q4215

 

 




Related Policies

Refer to Medical Policy S-33, Bio-Engineered Skin and Soft Tissue Substitutes, for additional information.


Covered Diagnosis Codes for Procedure Codes Q4132, Q4151 Q4154, Q 4159, Q4168 and Q4186 *L97 codes must be billed with one of the following codes from this section: E08.621-E13.622

E08.621

E08.622

E09.621

E09.622

E10.621

E10.622

E11.621

E11.622

E13.621

E13.622

L97.111

L97.112

L97.113

L97.114

L97.115

L97.116

L97.118

L97.121

L97.122

L97.123

L97.124

L97.125

L97.126

L97.128

L97.201

L97.202

L97.203

L97.204

L97.211

L97.212

L97.213

L97.214

L97.215

L97.216

L97.218

L97.221

L97.222

L97.223

L97.224

L97.225

L97.226

L97.228

L97.301

L97.302

L97.303

L97.304

L97.311

L97.312

L97.313

L97.314

L97.315

L97.316

L97.318

L97.321

L97.322

L97.323

L97.324 

L97.325

L97.326

L97.328

L97.401

L97.402

L97.403

L97.404

L97.411

L97.412

L97.413

L97.414

L97.415

L97.416

L97.418

L97.421

L97.422

L97.423

L97.424

L97.425

L97.426

L97.428

L97.501

L97.502

L97.503

L97.504

L97.511

L97.512

L97.513

L97.514

L97.515

L97.516

L97.518

L97.521

L97.522

L97.523

L97.524

L97.525

L97.526

L97.528

L97.801

L97.802

L97.803

L97.804

L97.811

L97.812

L97.813

L97.814

L97.815

L97.816

L97.818

L97.821

L97.822

L97.823

L97.824

L97.825

L97.826

L97.828

L97.901

L97.902

L97.903

L97.904

L97.911

L97.912

L97.913

L97.914

L97.915

L97.916

L97.918

L97.921

L97.922

L97.923

L97.924

L97.925

L97.926

L97.928

 

Covered Diagnosis Codes for Q4133 *L97 codes must be billed with one of the following codes from this section: E08.621-E13.622

E08.621

E08.622

E09.621

E09.622

E10.621

E10.622

E11.621

E11.622

E13.621

E13.622

I83.001

I83.011

I83.021

I83.201

I83.211

I83.221

I83.002

I83.012

I83.022

I83.202

I83.212

I83.222

I83.003

I83.013

I83.023

I83.203

I83.213

I83.223

I83.004

I83.014

I83.024

I83.204

I83.214

I83.224

I83.005

I83.015

I83.025

I83.205

I83.215

I83.225

I83.008

I83.018

I83.028

I83.208

I83.218

I83.228

I83.009

I83.019

I83.029

I83.209

I83.219

I83.229

L97.111

L97.112

L97.113

L97.114

L97.211

L97.212

L97.213

L97.214

L97.215

L97.216

L97.218

L97.221

L97.222

L97.223

L97.224

L97.225

L97.226

L97.228

L97.301

L97.302

L97.303

L97.304

L97.311

L97.312

L97.313

L97.314

L97.315

L97.316

L97.318

L97.321

L97.322

L97.323

L97.324 

L97.325

L97.326

L97.328

L97.401

L97.402

L97.403

L97.404

L97.411

L97.412

L97.413

L97.414

L97.415

L97.416

L97.418

L97.421

L97.422

L97.423

L97.424

L97.425

L97.426

L97.428

L97.501

L97.502

L97.503

L97.504

L97.511

L97.512

L97.513

L97.514

L97.515

L97.516

L97.518

L97.521

L97.522

L97.523

L97.524

L97.525

L97.526

L97.528

L97.801

L97.802

L97.803

L97.804

L97.811

L97.812

L97.813

L97.814

L97.815

L97.816

L97.818

L97.821

L97.822

L97.823

L97.824

L97.825

L97.826

L97.828

L97.901

L97.902

L97.903

L97.904

L97.911

L97.912

L97.913

L97.914

L97.915

L97.916

L97.918

L97.921

L97.922

L97.923

L97.924

L97.925

L97.926

L97.928

 

Covered Diagnosis Codes for Procedure Codes 65779, Q4100 and V2790

H11.001

H11.002

H11.003

H11.011

H11.012

H11.013

H11.021

H11.022

H11.023

H11.031

H11.032

H11.033

H11.041

H11.042

H11.043

H11.051

H11.052

H11.053

H11.061

H11.062

H11.063

H16.001

H16.002

H16.003

H16.011

H16.012

H16.013

H16.021

H16.022

H16.023

H16.031

H16.032

H16.033

H16.041

H16.042

H16.043

H16.051

H16.052

H16.053

H16.061

H16.062

H16.063

H16.071

H16.072

H16.073

H16.231

H16.232

H16.233

H18.501

H18.502

H18.503

H18.509

H18.511

H18.512

H18.513

H18.519

H18.521

H18.522

H18.523

H18.529

H18.531

H18.532

H18.533

H18.539

H18.541

H18.542

H18.543

H18.549

H18.551

H18.552

H18.553

H18.559

H18.591

H18.592

H18.593

H18.599

H18.831

H18.832

H18.833

L51.1

 

 

 

 

Covered Diagnosis Codes for procedure code 65778

H04.121

H04.122

H04.123

H04.129

H16.071

H16.072

H16.073

H16.079

H16.401

H16.402

H16.403

H16.409

H16.411

H16.412

H16.413

H16.419

H16.421

H16.422

H16.423

H16.429

H16.431

H16.432

H16.433

H16.439

H16.441

H16.442

H16.443

H16.449

H18.10

H18.11

H18.12

H18.13

H18.30

H18.52

H18.831

H18.832

H18.833

H18.839

H18.891

H18.892

H18.893

H18.899

I87.2

T26.10XA

T26.10XD

T26.10XS

T26.11XA

T26.11XD

T26.11XS

T26.12XA

T26.12XD

T26.12XS

T26.20XA

T26.20XD

T26.20XS

T26.21XA

T26.21XD

T26.21XS

T26.22XA

T26.22XD

T26.22XS

T26.31XA

T26.31XD

T26.31XS

T26.32XA

T26.32XD

T26.32XS

T26.40XA

T26.40XD

T26.40XS

T26.41XA

T26.41XD

T26.41XS

T26.42XA

T26.42XD

T26.50XA

T26.50XD

T26.50XS

T26.51XA

T26.51XD

T26.51XS

T26.52XA

T26.52XD

T26.52XS

T26.60XA

T26.60XD

T26.60XS

T26.61XA

T26.61XD

T26.61XS

T26.62XA

T26.62XD

T26.62XS

T26.70XA

T26.70XD

T26.70XS

T26.71XA

T26.71XD

T26.71XS

T26.72XA

T26.72XD

T26.72XS

T26.80XA

T26.80XD

T26.80XS

T26.81XA

T26.81XD

T26.81XS

T26.82XA

T26.82XD

T26.82XS

T26.90XA

T26.90XD

T26.90XS

T26.91XA

T26.91XD

T26.91XS

T26.92XA

T26.92XD

T26.92XS

T260.42XS

 

 

 

 

 



Place of Service: Inpatient/Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Amniotic membrane and amniotic fluid is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business



Links






This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • 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 the Claims Administrator/Insurer 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, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. 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.

This information is issued by Highmark Blue Shield on behalf of its affiliated Blue companies, which are independent licensees of the Blue Cross Blue Shield Association.  Highmark Inc. d/b/a Highmark Blue Shield and certain of its affiliated Blue companies serve Blue Shield members in the 21 counties of central Pennsylvania. As a partner in joint operating agreements, Highmark Blue Shield also provides services in conjunction with a separate health plan in southeastern Pennsylvania.  Highmark Inc. or certain of its affiliated Blue companies also serve Blue Cross Blue Shield members in 29 counties in western Pennsylvania, 13 counties in northeastern Pennsylvania, the state of West Virginia plus Washington County, Ohio, the state of Delaware[ and [8] counties in western New York and Blue Shield members in [13] counties in northeastern New York].  All references to Highmark in this document are references to Highmark Inc. d/b/a Highmark Blue Shield and/or to one or more of its affiliated Blue companies.





Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • 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 the Claims Administrator/Insurer 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, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. 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.