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Sterile Gloves.Pdf Clinical Medical Policy Department Clinical Affairs Division Sterile Gloves and Non Sterile Gloves [For the list of services and procedures that need preauthorization, please refer to www.mcs.com.pr. Go to “Comunicados a Proveedores”, and click “Cartas Circulares”.] Medical Policy: MP-DME-06-10 Original Effective Date: October 28, 2010 Revised: January 22, 2021 Next Revision: January, 2022 This policy applies to products subscribed by the following corporations, MCS Life Insurance Company (Commercial), and MCS Advantage, Inc. (Classicare) and Medical Card System, Inc., provider’s contract; unless specific contract limitations, exclusions or exceptions apply. Please refer to the member’s benefit certification language for benefit availability. Managed Care guidelines related to referral authorization, and precertification of inpatient hospitalization, home health, home infusion and hospice services apply subject to the aforementioned exceptions. DESCRIPTION Gloves are used to prevent contamination of healthcare personnel hands when: a) anticipating direct contact with blood or body fluids, mucous membranes, nonintact skin and other potentially infectious material; b) having direct contact with patients who are colonized or infected with pathogens transmitted by the contact route (e.g., VRE, MRSA, RSV); or c) handling or touching visibly or potentially contaminated patient care equipment and environmental surfaces. Gloves can protect both patients and healthcare personnel from exposure to infectious material that may be carried on hands. The selection of glove type should be made following a suitable and sufficient risk assessment of the nature of the task, the risk to the patient and the risk to healthcare personnel. The Center for Devices and Radiological Health, FDA, has responsibility for regulating the medical glove industry. Medical gloves include those marketed as sterile surgical or nonsterile examination gloves made of vinyl, latex or nitrile. General purpose utility ("rubber") gloves are also used in the healthcare setting, but they are not regulated by FDA since they are not promoted for medical use. There are no reported differences in barrier effectiveness between intact latex and intact vinyl used to manufacture gloves. Thus, the type of gloves selected should be appropriate for the task being performed. (CDC, 1988). The following general guidelines are recommended (CDC, 1988): 1. Use sterile gloves1 for procedures involving contact with normally sterile areas of the body. 2. Use examination gloves2 for procedures involving contact with mucous membranes, unless otherwise indicated, and for other patient care or diagnostic procedures that do not require the use of sterile gloves. 3. Change gloves between patient contacts. 4. Do not wash or disinfect surgical or examination gloves for reuse. Washing with surfactants may cause "wicking," (i.e., the enhanced penetration of liquids through undetected holes in the glove). Disinfecting agents may cause deterioration. This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 1 Medical technology is constantly changing and we reserve the right to review and update our policies periodically. Medical Card System, Inc. 1 All Rights Reserved® Clinical Medical Policy Department Clinical Affairs Division 5. Use general-purpose utility gloves (e.g., rubber household gloves) for housekeeping chores involving potential blood contact and for instrument cleaning and decontamination procedures. Utility gloves may be decontaminated and reused but should be discarded if they are peeling, cracked, or discolored, or if they have punctures, tears, or other evidence of deterioration. Note1: Sterile gloves are medical devices that are used for aseptic procedures involving contact with sterile areas of the body. Note2: Examination gloves are medical devices that are used for procedures involving contact with mucous membranes, unless otherwise indicated, and for other patient care or diagnostic procedures that do not require the use of sterile gloves. Aseptic technique — Asepsis or aseptic means free from pathogenic microorganisms. Aseptic technique is the purposeful prevention of the transfer of organisms from one person to another by keeping the microbe count to an irreducible minimum. Some authors have made a distinction between surgical asepsis or “sterile technique” used in surgery and medical asepsis or “clean technique” that involves procedures to reduce the number and transmission of pathogens. (APIC, 2012) Clean technique — Clean means free of dirt, marks, or stains. Clean technique involves strategies used in patient care to reduce the overall number of microorganisms or to prevent or reduce the risk of transmission of microorganisms from one person to another or from one place to another. Clean technique involves meticulous handwashing, maintaining a clean environment by preparing a clean field, using clean gloves and sterile instruments, and preventing direct contamination of materials and supplies. No “sterile to sterile” rules apply. This technique may also be referred to as non-sterile. Clean technique is considered most appropriate for long-term care, home care, and some clinic settings; for patients who are not at high risk for infection; and for patients receiving routine dressings for chronic wounds such as venous ulcers, or wounds healing by secondary intention with granulation tissue. (APIC, 2012) COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate member certificate and subscriber agreement contract for applicable diagnostic imaging, DME, laboratory, machine tests, benefits and coverage. INDICATIONS Medical Card System, Inc., (MCS) will approve the use of this medical policy when is intended to act as a guide to define medical necessity for the approval of Sterile Gloves or Non Sterile Gloves in the home setting. I. STERILE GLOVES A. Sterile gloves are considered medically necessary for under the following clinical scenarios (Applies to the Commercial LOB Only): This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 2 Medical technology is constantly changing and we reserve the right to review and update our policies periodically. Medical Card System, Inc. 2 All Rights Reserved® Clinical Medical Policy Department Clinical Affairs Division 1. All invasive insertion procedures. 2. Catheter or central venous line care. 3. Sterile dressing changes (surgical wounds). 4. Bladder catheterization. 5. Endstage renal disease (ESRD), for the peritoneal dialysis treatment modality in a home setting. 6. Immunocompromised individuals that normally require the use of “clean gloves” but become heavily compromised may require the use of “sterile gloves” when medically necessary. 7. Dressing of certain wounds healing by primary intention (e.g., skin or mucous membrane when the possibility of high risk of infection and contamination exist). 8. Use of sterile gloves for tracheotomy manipulation while the stoma is healing, in neonates, premature infants and in patients with recurrent infections (i.e. infections of trachea or lower respiratory track). B. Sterile gloves are considered medically necessary for the aforementioned clinical scenarios (See Indications Section I A, except for indication #5. (Applies to the Classicare LOB Only) II. NON STERILE GLOVES OR CLEAN GLOVES (SINGLE USE) Clean gloves rather than sterile gloves are acceptable for the following clinical scenarios: 1. Dressing of wound healing by secondary intention (e.g. wounds over six (6) weeks old, pressure sores, leg ulcers, dehisced wounds and simple grazes, removing drains or sutures,). If these wounds enter deeper sterile body areas, then an ASEPTIC (non-touch) technique must be used. 2. Clean gloves may be used for tracheotomy care in a home setting. Physician’s orders for the use of sterile gloves for tracheotomy care in a home setting will be evaluated on a case by case basis. 3. Nonsterile Gloves or Clean Gloves (single use) should be worn when in direct contact with blood, body fluids, non-intact skin or mucous membranes. 4. For management and care of gastrostomies and colostomies. This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 3 Medical technology is constantly changing and we reserve the right to review and update our policies periodically. Medical Card System, Inc. 3 All Rights Reserved® Clinical Medical Policy Department Clinical Affairs Division LIMITATIONS (Applies to the Classsicare LOB Only) 1. Sterile gloves will not be covered in patients receiving peritoneal dialysis at home, since this benefit is covered by the ESRD benefit. CODING INFORMATION HCPCS® CODES (List may not be all inclusive) HCPCS® Codes Description A4927 Gloves, non-sterile, per 100 A4930 Gloves, sterile, per pair 2020 HCPCS LEVEL II Professional Edition® (American Medical Association) REFERENCES 1. American Academy of Orthopaedic Surgeons. (2012). Information Statement: Preventing the Transmission of Bloodborne Pathogens. Original dated: 2001. Revised June 2008. Reviewed June 2012. Accessed January 14, 2021. Available at URL Address: https://aaos.org/globalassets/about/bylaws-library/information-statements/1018-preventing- the-transmission-of-bloodborne-pathogens.pdf 2. American Thoracic Society. (1999). Care of the Child with a Chronic Tracheostomy.
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