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Date Printed: August 22, 2017: 07:08 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-A9000-01

Original Effective Date: 10/15/10

Reviewed: 08/22/13

Revised: 10/01/16

Subject: Supersaturated Calcium Phosphate Oral Rinses (i.e., artificial saliva)

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. Supersaturated calcium phosphate oral rinse is a mouth rinse which is used to prevent and treat oral mucositis. It is an electrolyte solution resembling human saliva, developed to moisten, lubricate, and cleanse the mouth to help keep the mouth healthy. Caphosol® and NeutraSal® are examples of supersaturated calcium phosphate oral rinses and should be used alongside normal oral hygiene measures, such as regular tooth brushing.

Caphosol® is packaged as two separate containers, one clear and one blue, which should be mixed together to provide a single dose of treatment. The solution is used as a mouth rinse and should not be swallowed, but expelled after rinsing. NeutraSal® is a powder containing ingredients in a packet intended to be dissolved or dispersed in 30 millimeters of water (tap water, distilled or purified water) before administration.

These products should be used 4 times a day at first, but can be used up to 10 times a day, as prescribed by the treating physician if mucositis starts to develop. It is recommended that the rinse be used from the beginning of radiation or high dose chemotherapy and continued through completion of radiation or high dose chemotherapy. The symptoms of oral mucositis can begin up to two weeks after the start of cancer treatment, sometimes lasting up to 2 to 6 weeks after cancer treatment is completed.

POSITION STATEMENT:

NOTE: Supersaturated calcium phosphate rinse is considered to be a medical supply rather than a drug and is typically supplied by a Durable Medical Equipment or Medical Supply provider.

Supersaturated calcium phosphate rinse meets the definition of medical necessity as an adjunct to standard oral care for the treatment of muscositis caused by radiation or high dose chemotherapy, when prescribed by the treating physician for use during radiation treatment or high dose chemotherapy.

The use of Supersaturated calcium phosphate rinse does not meet the definition of medical necessity when used for routine dry mouth or dry throat (i.e., hyposalivation, xerostomia) in the absence of high dose chemotherapy or radiation treatment.

BILLING/CODING INFORMATION:

HCPCS Coding:

A9155

Artificial saliva, 30 ml

Note: A9155 should be reported with a unit of one (1) for each 30 milliliters (ml) ordered. Example: 120 ml = 4 units.

LOINC Codes:

The following information may be required documentation to support medical necessity: Physician history and physical, initial assessment, procedure note, visit note.

Documentation Table

LOINC Codes

LOINC
Time Frame
Modifier Code

LOINC Time Frame Modifier Codes Narrative

Physician history and physical

28626-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Attending physician visit note or treatment notes

18733-6

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Attending physician progress note

18741-9

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Clinical notes and chart section

28650-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Current, discharge, or administered medications

34483-8

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

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) and/or Local Coverage Determination (LCD) were found at the time of the last guideline reviewed date.

DEFINITIONS:

Hyposalivation: decreased flow of saliva.

Mucositis: the painful inflammation and ulceration of the mucous membranes lining the digestive tract, usually as an adverse effect of chemotherapy and radiotherapy treatment for cancer. Mucositis can occur anywhere along the gastrointestinal (GI) tract, but oral mucositis refers to the particular inflammation and ulceration that occurs in the mouth.

Xerostomia: dryness of the mouth due to salivary gland dysfunction.

RELATED GUIDELINES:

None applicable.

OTHER:

Indexing terms include:

Note: 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.


Artificial saliva
Caphosol®
NeutraSal®
Supersaturated calcium phosphate

REFERENCES:

  1. Caphosol® product label. Catalent Pharma Solutions LLC. Revised 07/09.
  2. Caphosol® website. Accessed 09/01/10.
  3. ClinicalTrials.gov. NCT00901732, NCT00965172, NCT01066624, NCT01046812, NCT01305200, and NCT01265810. Accessed 07/11/13.
  4. Harris DJ, Eilers J, Harriman A, Cashavelly BJ, Maxwell C. Putting evidence into practice: evidence-based interventions for the management of oral mucositis. Clin J Oncol Nurs. 2008 Feb;12(1): 141-52.
  5. Keefe DM, Schubert MM, Elting LS, Sonis ST, Epstein JB, Raber-Durlacher JE, Migliorati CA, McGuire DB, Hutchins RD, Peterson DE; Mucositis Study Section of the Multinational Association of Supportive Care in Cancer and the International Society for Oral Oncology. Updated clinical practice guidelines for the prevention and treatment of mucositis. Cancer. 2007 Mar 1; 109(5):820-31.
  6. Kostler WJ, Hejna M, Wenzel C, Zielinski CC. Oral mucositis complicating chemotherapy and/or radiotherapy: options for prevention and treatment. CA Cancer J Clin. 2001 Sep-Oct; 51(5):290-315.
  7. Lalla RV, Sonis ST, Peterson DE. Management of oral mucositis in patients who have cancer. Dent Clin North Am. 2008 Jan;52(1):61-77, viii.
  8. Markiewicz M, Dzierzak-Mietla M, Frankiewicz A, Zielinska P, Koclega A, Kruszelnicka M, Kyrcz-Krzemien S. Treating oral mucositis with a supersaturated calcium phosphate rinse: comparison with control in patients undergoing allogeneic hematopoietic stem cell transplantation. Support Care Cancer. 2012 Sep;20(9):2223-9.
  9. Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) Evidence-based Clinical Practice Guidelines for Mucositis Secondary to Cancer Therapy (05/13/13)
  10. NeutraCal® package insert. Accessed 11/08/12.
  11. Ridge JA, Glisson BS, Lango MN. Cancer Management: A Multidisciplinary Approach, 12th Edition (2009). Vol. No. March 5, 2010.
  12. Sonis ST. Oral Mucositis in Cancer Therapy. Supportive Oncology. Nov/Dec 2004; Vol 2 (Suppl 3): pp3-8.
  13. U.S. Food and Drug Administration (FDA) 501(k) K030802 (Caphosol), 11/25/03.
  14. U.S. Food and Drug Administration (FDA) 501(k) K091718 (NeutraSal), 09/02/09.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 08/22/13.

GUIDELINE UPDATE INFORMATION:

10/15/10

New Medical Coverage Guideline.

06/15/11

Revision of Position Statement to add an informational note regarding Caphosol being considered a medical supply rather than a drug.

09/15/11

Revision; formatting changes.

09/15/12

Annual review; position statement unchanged; instructional note added to Billing/Coding section.

01/15/13

Revision to change title from brand names to generic description; position statement unchanged; formatting changes.

09/15/13

Scheduled review: position statement unchanged; Program Exceptions section updated; references updated.

11/01/15

Revision: ICD-9 Codes deleted.

10/01/16

Revision; coding section updated.

Date Printed: August 22, 2017: 07:08 AM