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Date Printed: August 22, 2017: 07:12 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-00000-01

Original Effective Date: 05/15/17

Reviewed: 04/27/17

Revised: 00/00/00

Subject: ProThelial™ for the Treatment of Oral Mucositis

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates      
           

DESCRIPTION:

Oral mucositis is a common and often debilitating complication of cancer treatment. Oral mucositis describes inflammation of the oral mucosa and typically manifests as erythema or ulcerations that appear 7 to 10 days after initiation of high-dose cancer therapy. Oral mucositis can cause significant pain and increased risk of systemic infection, dependency on total parenteral nutrition, and use of narcotic analgesics. There are a number of interventions for oral mucositis that may partially control symptoms, but none is considered a criterion standard treatment. When uncomplicated by infection, oral mucositis is self-limited and usually heals within 2 to 4 weeks after cessation of cytotoxic chemotherapy.

One intervention proposed is the use of ProThelial. ProThelial is polymerized sucralfate malate paste that forms a protective layer over the oral mucosa by adhering to the mucosal surface to protect against further irritation and relieve pain. The paste may be used in the management of mouth lesions of all types, including stomatitis and mucositis. Though ProThelial contains sucralfate, it has been approved by the U.S. Food and Drug Administration (FDA) and is classified as a medical device. The device uses sucralfate as the active component to achieve the clinical effect and requires the facilitated polymerization of sucralfate in order for the devices to function. It requires direct application, transient contact with the patient and multiple administrations for use.

POSITION STATEMENT:

ProThelial is considered experimental or investigational for all indications, including as an adjunct to standard oral care for the treatment of oral mucositis. The evidence is insufficient to determine the effects of the technology on health outcomes.

BILLING/CODING INFORMATION:

There is no specific HCPCS code to report ProThelial. It may be billed using code J3490.

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

No National Coverage Determination (NCD) or Local Coverage Determination (LCD) was found at the time of the last guideline reviewed date.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

None applicable.

OTHER:

None applicable

REFERENCES:

  1. Allison RR, Ambrad AA, et al, Multi-institutional, randomized, double-blind, placebo-controlled trial to assess the efficacy of a mucoadhesive hydrogel (MuGard) in mitigating oral mucositis symptoms in patients being treated with chemoradiation therapy for cancers of the head and neck; Cancer. 2014 May 1;120(9):1433-40.
  2. Bensinger W, Schuber M, et al, NCCN Task Force Report: Prevention and Management of Mucositis in Cancer Care; J Natl Compr Canc Netw. 2008 Jan;6 Suppl 1:S1-21; quiz S22-4.
  3. ClinicalTrials.gov, Treatment and Prevention of Oral and Alimentary Mucositis Using Polymerized Cross-Linked High Potency Sucralfate as a Single Agent Therapy, sponsored by Ashley Downs Bioscience, accessed 04/17/17.
  4. Foote M, The Importance of Planned Dose of Chemotherapy on Time: Do We Need to Change Our Clinical Practice? Oncologist. 1998;3(5):365-368.
  5. Glasziou P, Chalmers I, et al, When are randomised trials unnecessary? Picking signal from noise. BMJ. 2007 Feb 17;334(7589):349-51.
  6. Lalla RV, Bowen J, et al, MASCC=ISOO Clinical Practice Guidelines for the Management of Mucositis Secondary to Cancer Therapy Cancer; 2014 May 15;120(10):1453-61.
  7. McCullough RW, A 66 Patient Multi-Institution Phase IV Post-Authorization Surveillance of ProThelial™ (High Potency Polymerized Cross-linked Sucralfate) -Single Agent Efficacy for the Prevention and Rapid Reversal of Chemo-radiation Induced Oral, Esophageal and Intestinal Mucositis; British Journal of Medicine and Medical Research, vol. 10, issue 2, pp. 1-17, 2015.
  8. McCullough RW, New category of evidence should permit the multinational association of support in cancer care (MASCC) to review polymerized cross-linked sucralfate paste (ProThelial™) for mucositis guidelines; Oncology Discovery 2014, accessed at hoajonline.com/journals 04/17/17.
  9. ProThelial™ website, accessed at prothelial.com 04/17/17.
  10. Russo G, Haddad R, et al, Radiation Treatment Breaks and Ulcerative Mucositis in Head and Neck Cancer, Oncologist. 2008 Aug;13(8):886-98.
  11. U.S. Food and Drug Administration (FDA) 501(k) K123904 (ProThelial), 08/07/13; accessed 04/17/17.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 04/27/17.

GUIDELINE UPDATE INFORMATION:

05/15/17

New Medical Coverage Guideline.

Date Printed: August 22, 2017: 07:12 AM