HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
E-47-013
Topic:
Non-Powered Negative Pressure Wound Therapy System
Section:
Durable Medical Equipment
Effective Date:
October 30, 2017
Issued Date:
March 4, 2019
Last Revision Date:
February 2019
Annual Review:
February 2019
 
 

The purpose of the non-powered negative pressure wound therapy system (NPWT) is to promote wound healing. The non-powered NPWT system is a portable negative pressure wound therapy device indicated for individuals who would benefit from a suction device particularly as the device may promote wound healing. It is also indicated for removal of small amounts of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (e.g., diabetic or pressure), and surgically closed incisions and flaps.

Policy Position

A non-powered negative pressure wound therapy system (e.g., Smart Negative Pressure [SNaP] Wound Care System, PICO) and related supplies may be considered medically necessary for the following conditions:

  • The individual has a chronic (i.e., being present for at least 30 days) Stage III or IV pressure ulcer, diabetic ulcer of the lower extremity or venous ulcer of the lower extremity.
  • An ulcer therapy program as described below, as applicable to the type of ulcer, should have been tried or considered and ruled out prior to application of non-powered NPWT.
    • For all ulcers, the ulcer therapy program must include a minimum of all of the following general measures which should either be addressed, applied, or considered and ruled out prior to application of non-powered NPWT:
      • Documentation in the individual’s medical record of evaluation, care and ulcer measurements by a licensed medical professional; and
      • Application of dressings to maintain a moist environment; and
      • Debridement of necrotic tissue if present; and
      • Evaluation of and provision for adequate nutritional status.
    • For Stage III or IV pressure ulcers:
      • The individual has been appropriately turned and positioned; and
      • The individual  has used an appropriate support surface for pressure ulcers on the posterior trunk or pelvis; and
      • The individual’s moisture and incontinence have been appropriately managed.
    • For diabetic ulcers:
      • The individual has been on a comprehensive diabetic management program; and
      • Reduction in pressure on a foot ulcer has been accomplished with appropriate modalities.
    • For venous insufficiency ulcers:
      • Compression bandages and/or garments have been consistently applied; and
      • Leg elevation and ambulation have been encouraged.  

A non-powered NPWT system will be denied as not medically necessary when submitted for the treatment of surgical (e.g., dehiscence), traumatic, and other types of wounds.

Once placed on a non-powered NPWT system and supplies, in order for coverage to continue, a licensed medical professional must, on a regular basis:

  • Directly assess the ulcer(s) being treated with the non-powered NPWT system; and
  • At least monthly, document changes in the ulcer's dimensions and characteristics. 

The health care professional must also record ulcer measurements consistently and regularly in the individual’s records. This documentation is necessary to establish the medical necessity of the device for the individual and must continue in order for coverage to continue for an eligible non-powered NPWT system.

A licensed health care professional, for the purposes of this policy, may be a physician, physician's assistant (PA), registered nurse (RN), licensed practical nurse (LPN), or physical therapist (PT). The practitioner should be licensed to assess ulcers and/or administer ulcer care within the state where the member is receiving non-powered NPWT.

97607

97608

 

 

 

 

 




A non-powered NPWT system used in the treatment of children from birth up to and including 12 years of age is considered experimental/investigational and, therefore, non-covered. According to the U.S. Food and Drug Administration (FDA), the safety and effectiveness of NPWT systems in newborns, infants and children has not been established.

97607

97608

 

 

 

 

 




A non-powered NPWT system and supplies will be denied at any time as not medically necessary, if ONE OR MORE of the following are present:

  • Actively infected ulcers; or
  • Inadequately drained ulcers; or
  • Inadequately debrided ulcers; or
  • Exposed blood vessels, anastomotic sites, organs, tendons, or nerves; or
  • Ulcer containing malignancy; or
  • Fistulas; or
  • Untreated osteomyelitis within the vicinity of the ulcer; or
  • Actively bleeding ulcers.

The non-powered NPWT system and supplies will be denied as not medically necessary with ANY of the following, whichever occurs first:

  • Adequate ulcer healing has occurred to the degree that non-powered NPWT may be discontinued, in the judgment of the treating physician; or
  • Any measurable degree of ulcer healing has failed to occur over the prior month as documented in the  individual’s records; or
  • Four months (including the time non-powered NPWT was applied in an inpatient setting prior to discharge to the home) have elapsed using a non-powered NPWT device in the treatment of any ulcer. 

Coverage beyond 4 months will be given individual consideration based upon additional documentation.

This additional documentation must address the initial condition of the ulcer including measurements, efforts to address all aspects of ulcer care, subsequent monthly ulcer measurements, and what changes in ulcer therapy are being applied to effect ulcer healing. This information must be updated with each subsequent request for additional months of use of non-powered NPWT.

97607

97608

A9272

 

 

 

 




Supplies

Supplies for non-powered NPWT are limited to the following. Requests for amounts greater than the stated limits will be denied as not medically necessary.

  • Cartridge - 10 cartridges per ulcer per month - Additional cartridges per month must be supported by documentation evidencing the volume of drainage of exudates.
  • Dressings – 10 dressings per ulcer per month - Additional dressings per month must be supported by documentation in the individual’s medical record, and must be available upon request. 

Currently, the available non-powered NPWT dressing is 15x15cm in size. Allowing for the suggested 1cm overlap on each border to create a good seal, 13x13cm is currently the maximum diameter for the ulcer being treated with this system. 

Only 1 strap per episode of treatment may be considered medically necessary.

A9272

 

 

 

 

 

 




Staging of Pressure Ulcers

The following description of staging of pressure ulcers should be used when reviewing use of the NPWT device in the treatment of ulcers: 

Stage I: Observable pressure related alteration of intact skin whose indicators as compared to the adjacent or opposite area on the body may include changes in one or more of the following: skin temperature (warmth or coolness), tissue consistency (firm or boggy feel), and/or sensation (pain, itching). The ulcer appears as a defined area of persistent redness in lightly pigmented skin, whereas in darker skin tones, the ulcer may appear with persistent red, blue, or purple hues. 

Stage II: Partial thickness skin loss involving epidermis and/or dermis. The ulcer is superficial and presents clinically as an abrasion, blister, or shallow crater. 

Stage III: Full thickness skin loss involving damage to, or necrosis of, subcutaneous tissue that may extend down to, but not through, underlying fascia. The ulcer presents clinically as a deep crater with or without undermining of adjacent tissue. 

Stage IV: Full thickness skin loss with extensive destruction, tissue necrosis or damage to muscle, bone, or supporting structures (e.g., tendon, joint capsule). Undermining and sinus tracts also may be associated with Stage IV pressure ulcers. 


Related Policies

Refer to Medical Policy E-31 Negative Pressure Wound Therapy (NPWT) Pumps/Vacuum Assisted Closure (VAC) of Chronic Wounds for additional information.


Covered Diagnosis Codes For procedure codes 97607, 97608, and A9272.

 

E08.51

E08.52

E08.59

E08.610

E08.618

E08.621

E08.622

E08.628

E08.630

E08.638

E08.69

E08.8

E08.9

E09.39

E09.40

E09.41

E09.42

E09.43

E09.44

E09.49

E09.51

E09.52

E09.59

E09.610

E09.618

E09.620

E09.621

E09.622

E09.628

E09.630

E09.638

E09.69

E10.21

E10.40

E10.41

E10.42

E10.43

E10.44

E10.49

E10.51

E10.52

E10.59

E10.610

E10.618

E10.620

E10.621

E10.622

E10.628

E10.630

E10.638

E10.65

E10.69

E10.8

E10.9

E11.21

E11.39

E11.40

E11.41

E11.42

E11.43

E11.44

E11.49

E11.51

E11.52

E11.59

E11.610

E11.618

E11.620

E11.621

E11.622

E11.628

E11.630

E11.638

E11.69

E11.8

E11.9

E13.21

E13.39

E13.40

E13.41

E13.42

E13.43

E13.44

E13.49

E13.51

E13.52

E13.59

E13.610

E13.618

E13.620

E13.621

E13.622

E13.628

E13.630

E13.638

E13.69

E13.8

E13.9

I70.231

I70.231

I70.232

I70.233

I70.233

I70.234

I70.234

I70.235

I70.235

I70.238

I70.238

I70.239

I70.239

I70.241

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I70.242

I70.243

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I70.245

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I70.248

I70.248

I70.249

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I70.331

I70.331

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I70.333

I70.333

I70.334

I70.334

I70.335

I70.335

I70.338

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I70.342

I70.343

I70.343

I70.344

I70.344

I70.345

I70.345

I70.348

I70.348

I70.349

I70.349

I70.431

I70.431

I70.432

I70.433

I70.433

I70.434

I70.434

I70.435

I70.435

I70.438

I70.438

I70.439

I70.439

I70.441

I70.441

I70.442

I70.443

I70.443

I70.444

I70.444

I70.445

I70.445

I70.448

I70.448

I70.449

I70.449

I70.531

I70.531

I70.532

I70.533

I70.533

I70.534

I70.534

I70.535

I70.535

I70.538

I70.538

I70.539

I70.539

I70.541

I70.541

I70.542

I70.543

I70.543

I70.544

I70.544

I70.545

I70.545

I70.548

I70.548

I70.549

I70.549

I70.631

I70.631

I70.632

I70.633

I70.633

I70.634

I70.634

I70.635

I70.635

I70.638

I70.638

I70.639

I70.639

I70.641

I70.641

I70.642

I70.643

I70.643

I70.644

I70.644

I70.645

I70.645

I70.648

I70.648

I70.649

I70.649

I70.731

I70.731

I70.732

I70.733

I70.733

I70.734

I70.734

I70.735

I70.735

I70.738

I70.738

I70.739

I70.739

I70.741

I70.741

I70.742

I70.743

I70.743

I70.744

I70.744

I70.745

I70.745

I70.748

I70.748

I70.749

I70.749

I83.001

I83.002

I83.003

I83.004

I83.005

I83.008

I83.009

I83.011

I83.012

I83.013

I83.014

I83.015

I83.018

I83.019

I83.021

I83.022

I83.023

I83.024

I83.025

I83.028

I83.029

I83.201

I83.202

I83.203

I83.204

I83.205

I83.208

I83.209

I83.211

I83.212

I83.213

I83.214

I83.215

I83.218

I83.219

I83.221

I83.222

I83.223

I83.224

I83.225

I83.228

I83.229

I87.011

I87.012

I87.013

I87.019

I87.031

I87.032

I87.033

I87.039

I87.2

I87.2

I87.311

I87.311

I87.312

I87.312

I87.313

I87.313

I87.319

I87.9

I87.9

L89.003

L89.004

L89.013

L89.014

L89.023

L89.024

L89.103

L89.104

L89.113

L89.114

L89.123

L89.124

L89.133

L89.134

L89.143

L89.144

L89.153

L89.154

L89.203

L89.204

L89.213

L89.214

L89.223

L89.224

L89.303

L89.313

L89.314

L89.323

L89.324

L89.43

L89.44

L89.503

L89.504

L89.513

L89.514

L89.523

L89.524

L89.603

L89.604

L89.613

L89.614

L89.623

L89.624

L89.813

L89.814

L89.893

L89.894

L89.93

L89.94

L97.101

L97.101

L97.102

L97.102

L97.103

L97.103

L97.104

L97.104

L97.109

L97.109

L97.111

L97.111

L97.112

L97.112

L97.113

L97.113

L97.114

L97.114

L97.119

L97.119

L97.121

L97.121

L97.122

L97.122

L97.123

L97.123

L97.124

L97.124

L97.129

L97.129

L97.201

L97.202

L97.203

L97.204

L97.209

L97.211

L97.212

L97.213

L97.214

L97.219

L97.221

L97.222

L97.223

L97.224

L97.229

L97.301

L97.301

L97.302

L97.302

L97.303

L97.303

L97.304

L97.304

L97.309

L97.309

L97.311

L97.311

L97.312

L97.312

L97.313

L97.313

L97.314

L97.314

L97.319

L97.319

L97.321

L97.321

L97.322

L97.322

L97.323

L97.323

L97.324

L97.324

L97.329

L97.329

L97.401

L97.401

L97.402

L97.402

L97.403

L97.403

L97.404

L97.404

L97.409

L97.409

L97.411

L97.411

L97.412

L97.412

L97.413

L97.413

L97.414

L97.414

L97.419

L97.419

L97.421

L97.421

L97.422

L97.422

L97.423

L97.423

L97.424

L97.424

L97.429

L97.429

L97.501

L97.501

L97.502

L97.502

L97.503

L97.503

L97.504

L97.504

L97.509

L97.509

L97.511

L97.511

L97.512

L97.512

L97.513

L97.513

L97.514

L97.514

L97.519

L97.519

L97.521

L97.521

L97.522

L97.522

L97.523

L97.523

L97.524

L97.524

L97.529

L97.529

L97.801

L97.801

L97.802

L97.802

L97.803

L97.803

L97.804

L97.804

L97.809

L97.809

L97.811

L97.811

L97.812

L97.812

L97.813

L97.813

L97.814

L97.814

L97.819

L97.819

L97.821

L97.821

L97.822

L97.822

L97.823

L97.823

L97.824

L97.824

L97.829

L97.829

L97.901

L97.901

L97.902

L97.902

L97.903

L97.903

L97.904

L97.904

L97.909

L97.909

L97.911

L97.911

L97.912

L97.912

L97.913

L97.913

L97.914

L97.914

L97.919

L97.919

L97.921

L97.921

L97.922

L97.922

L97.923

L97.923

L97.924

L97.924

L97.929

L97.929

 



Place of Service: Outpatient

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

The use of a Non-Powered NPWT System 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.

    Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.