Superseded Local Coverage Determination (LCD)

WOUND Application of Cellular and/or Tissue Based Products (CTPs), Lower Extremities

L36690

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Superseded
To see the currently-in-effect version of this document, go to the section.

Contractor Information

LCD Information

Document Information

LCD ID
L36690
LCD Title
WOUND Application of Cellular and/or Tissue Based Products (CTPs), Lower Extremities
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL36690
Original Effective Date
For services performed on or after 10/10/2016
Revision Effective Date
For services performed on or after 02/03/2022
Revision Ending Date
08/31/2022
Retirement Date
N/A
Notice Period Start Date
08/25/2016
Notice Period End Date
10/09/2016
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Current Dental Terminology © 2021 American Dental Association. All rights reserved.

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Issue

Issue Description

Link for #104 was broken and needed to be corrected

CMS National Coverage Policy

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for bioengineered skin substitutes. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for bioengineered skin substitutes and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies regarding bioengineered skin substitutes are found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:

  • CMS Internet-Only Manual (IOM), Pub. 100-04, Medicare Claims Processing Manual, Chapter 17, Section 40.
  • CMS Internet-Only Manual (IOM). Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, Section 270.13.
  • CMS Change Request, CR 8213; Autologous Platelet-Rich Plasma (PRP) for Chronic Non-Healing WOUNDs; issued June 10, 2013

Social Security Act (XVIII) Standard References:

  • Title XVIII of the Social Security Act, 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.
  • Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.
  • Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Notice: It is not appropriate to bill Medicare for services that are not covered (as described by this entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

The addition of Cellular and/or Tissue Based Products (CTPs) to certain WOUNDs may afford a healing advantage over dressings and conservative treatments when these options appear insufficient to affect complete healing.

There are currently a wide variety of bioengineered products available for soft tissue coverage to affect closure. These products may be derived from allogeneic, xenogeneic, synthetic sources or a combination of any or all of these types of materials. However, without the component of the recipient’s own distinct epithelium and cellular skin elements, permanent skin replacement or coverage by the graft cannot be accomplished.

Autologous skin grafts, also referred to as autografts, are permanent covers that use skin from different parts of the individual’s body. These grafts consist of the epidermis and a dermal component of variable thickness. A split-thickness skin graft (STSG) includes the entire epidermis and a portion of the dermis. A full thickness skin graft (FTSG) includes all layers of the skin. Although autografts are the optimal choice for full thickness WOUND coverage, areas for skin harvesting may be limited, particularly in cases of large burns or venous stasis ulceration. Harvesting procedures are painful, disfiguring and require additional WOUND CARE.

Allografts which use skin from another human (e.g., cadaver) and Xenografts which use skin from another species (e.g., porcine or bovine) may also be employed as temporary skin replacements, but they must later be replaced by an autograft or the ingrowth of the patient’s own skin.

Bioengineered Skin / Cultured Epidermal Autografts (CEA) are autografts derived from the patient’s own skin cells grown or cultured from very small amounts of skin or hair follicle. Production time is prolonged. One such product is grown on a layer of irradiated mouse cells, bestowing some elements of a xenograft. Wide spread usage has not been available due to limited availability or access to the technology.

Cellular and/or Tissue Based Products (CTPs), referred to as CTPs by CMS, The Current Procedural Terminology (CPT) and The Healthcare Common Procedure Coding Manuals, have been developed in an attempt to circumvent problems inherent with autografts, allografts and xenografts. These constitute biologic covers for refractory WOUNDs with full thickness skin loss secondary to 3rd degree burns or other disease processes such as diabetic neuropathic ulcers and the skin loss of chronic venous stasis or venous hypertension. The production of these biologic CTPs varies by company and product, but generally involves the creation of immunologically inert biological products containing protein, hormones or enzymes seeded into a matrix which may provide protein or growth factors proposed to stimulate or facilitate healing or promote epithelization. A variety of biosynthetic and tissue-engineered CTP products marketed as Human Skin Equivalents (HSE) or Cellular and/or Tissue-based Products (CTP) are manufactured under an array of trade names and marketed for a variety of indications. All are procured, produced, manufactured, processed and promoted in sufficiently different manners to preclude direct product comparison for equivalency or superiority in randomized controlled trials. Sufficient data is available to establish distinct inferiority to human skin autografts and preclude their designation as skin equivalence.

CTPs are classified into the following types:

  • Human skin allografts derived from donated human skin
  • Allogeneic matrices derived from human tissue (fibroblasts or membrane)
  • Composite matrices derived from human keratinocytes, fibroblasts and xenogeneic collagen
  • Acellular matrices derived from xenogeneic collagen or tissue

Human Skin Allografts are bioengineered from human skin components and human tissue which have had intact cells removed or treated to avoid immunologic rejection. They are available in different forms promoted to allow scaffolding, soft tissue filling, growth factors and other bioavailable hormonal or enzymatic activity.

Allogeneic Matrices are usually derived from human neonatal fibroblasts of the foreskin that may contain metabolically active or regenerative components primarily used for soft tissue support, though some have been approved for the treatment of full-thickness skin and soft tissue loss. Most are biodegradable and disappear after 3-4 weeks implantation.

Composite Matrices are derived from human keratinocytes and fibroblasts supported by a scaffold of synthetic mesh or xenogeneic collagen. These are also referred to as human skin equivalent but are unable to be used as autografts due to immunologic rejection or degradation of the living components by the host. Active cellular components continue to generate bioactive compounds and protein that may accelerate WOUND healing and epithelial regrowth.

Acellular Matrices are derived from other than human skin and include the majority of CTPs. All are composed of allogeneic or xenogeneic derived collagen, membrane, or cellular remnants proposed to simulate or exaggerate the characteristics of human skin. All propose to promote healing by the creation of localized intensification of an array of hormonal and enzymatic activity to accelerate closure by migration of native dermal and epithelial components, rather than function as distinctly incorporated tissue closing the skin defect.

For the purpose of this LCD, consideration is given to the use of dermal or epidermal substitute tissue of human or non-human origin, with or without bioengineered or processed elements, with or without metabolically active elements, with a designated use as coverage for a superficial skin deficit that has persisted, despite optimal WOUND CARE for a period of 4 weeks or greater. These products are those referred to as Human Cellular and/or Tissue Based Products (CTPs).

Evaluation of the clinical literature indicates that studies comparing the efficacy of CTPs to alternative WOUND CARE approaches with patients’ autologous skin are limited in number, apply mainly to generally healthy patients, and examine only a small portion of the CTP products available in the United States. Therefore, all products with FDA clearance/approval or designated 361 HCT/P exemption used in accordance with that product’s individualized application guidelines will be equally considered for the purpose of this LCD and may be considered reasonable and necessary.

Regulatory Status

US Food and Drug Administration (FDA) Governing CTP Products


The U.S. Food and Drug Administration (FDA) does not refer to any product or class of products as “skin substitutes.” However, products commonly described as “CTPs” are regulated by FDA under one of the four categories described below depending on the origin and composition of the product and listed as a “CTP” .

  1. Human Cells, Tissues, and Cellular and Tissue-Based Products - Cells and tissues taken from human donors and transplanted to a recipient are regulated under PHS 361 [21 CFR 1270 & 1271]. This regulation describes the rules concerning the use of HCT/Ps for human medical purposes. The final rule, 21 CFR Part 1271, became effective on April 4, 2001, for human tissues intended for transplantation that are regulated under section 361 of the PHS Act and 21 CFR Part 1270. HCT/Ps are regulated by the Center for Biologics Evaluation and Research (CBER). CBER is responsible for regulating biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. Establishments producing HCT/Ps must register with FDA and list their HCT/Ps. HCT/Ps establishments are not required to demonstrate the safety or effectiveness of their products and FDA does not evaluate the safety or effectiveness of these products. Products are recovered, processed, and distributed in compliance with FDA Good Tissue Practices and American Association of Tissue Banks (AATB) standards, maintain the necessary registration with the FDA, and undergo routine FDA inspection.
  2. Premarket Approval - Premarket approval (PMA) by FDA is the required process of scientific review to ensure the safety and effectiveness of Class III devices. Before Class III devices can be marketed, they must have an approved PMA application. Therefore, WOUND CARE products regulated under the PMA process will require evidence that they promote WOUND healing before they are approved for marketing.
  3. 510(k) Submissions - According to FDA documents a “510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent (SE), to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA." Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims. Unlike PMA, 510(k) confers reasonable assurance of safety and effectiveness via demonstration of substantial equivalence to a legally marketed device that does not require premarket approval. Therefore, WOUND CARE products regulated under the 510(k) process will not typically require clinical evidence to establish effectiveness in WOUND healing, as compared with products regulated under the PMA process in which substantial clinical evidence is always required.
  4. Humanitarian Device Exemption - An HDE is similar in both form and content to a premarket approval (PMA) application, but is exempt from the effectiveness requirements of a PMA. An HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose. The applicant must demonstrate that no comparable devices are available to treat or diagnose the disease or condition, and that they could not otherwise bring the device to market. HDE approval is based on evidence of probable benefit in a disease population occurring at a frequency of less than 4,000 patients per year in the United States.

    Updated designation and approved usage criteria may be found at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances.

    Expanded classification criteria and explanation is included in the HHS/AHRS Final Report, December 18, 2012, entitled Skin Substitutes for Treating Chronic WOUNDs.


Per the American Medical Association and the CPT Manual, “Skin Replacement Surgery” or “Skin Substitute Grafting” is a conceptual model focusing on the work and services provided regardless of the product used. This removes the requirement for maintenance and education on the use of supply codes that have little impact on the "typical patient" or the provider effort for application of the product. The application of CTP is distinguished according to the WOUND characteristics and surface area rather than by product description. Currently, no product has demonstrated individual superiority for the treatment of diabetic foot ulcers (DFU) and venous leg ulcers (VLU) of the lower extremity, and, frequently such products are utilized inappropriately.

Non-graft WOUND dressings are generally included in standard WOUND CARE management; such products may provide value and, in fact, may preclude the need for CTP application.

Standard treatment of chronic lower extremity ulcers or skin loss (e.g., DFU or VLU) primarily includes infection and edema control, mechanical offloading, mechanical compression or limb elevation, debridement of necrotic or infected tissue, and management of concomitant and inciting medical issues (blood glucose control, tobacco use). Maintenance of a therapeutic environment with appropriate dressings to preclude further trauma facilitates development of healthy granulation tissue and encourages re-epithelialization. A WOUND that fails to show evidence of healing by contraction and advancement of epithelial margins following 4 weeks of optimization, including all aspects of standard therapy, is considered a chronic non-healing WOUND and falls into the auspices of this LCD. The fundamental basis for non-healing of a WOUND is of paramount importance and must be corrected prior to consideration of additional therapy.

The depth of skin loss is the determinant of its ability to return. Full thickness skin loss, implying the loss of all elements of the epidermis and dermis, will require re-epithelization of the surface once a clean granular base is established. Both full and partial thickness skin loss may benefit from enhanced products referred to as CTPs. Though no CTPs are capable of replacing the patient’s own skin, they have been demonstrated to allow scaffolding for the growth of epithelium, enzymatic cleansing and provision of growth factors beneficial to deficit reduction and re-epithelization.

This document addresses the management of chronic non-healing WOUNDs or skin deficits of the lower extremities with the goal of WOUND and skin closure when standard or conservative measures have failed. While lower extremity ulcers have numerous causes such as burns, trauma, immobility, ischemia or other neurologic impairment, over 90% of the lesions are related to venous stasis disease and diabetic neuropathy. Therefore, the focus of this policy is the application of bioengineered skin substitute material to diabetic foot ulcers and venous leg ulcers of the lower extremities and the reasonable and necessary (R&N) threshold for utilization of CTPs. Particular emphasis is placed on the indications for application of CTP material for DFU and VLU.

Patients receiving a CTP graft must be under the CARE of a physician licensed by the state with full scope of practice for the treatment of the systemic disease process(s) etiologic for the condition (e.g., venous insufficiency, diabetes, neuropathy). If the provider performing the CTP graft/application is not the one providing the treatment for the systemic condition then a statement in the documentation that (s)he is aware of the systemic condition and that the patient is under the CARE of Doctor _____. This concurrent medical management and the identity of the managing medical physician shall be clearly discernable in the medical record and available upon request.

Medicare coverage for WOUND CARE on a continuing basis, for a single WOUND, in an individual patient is contingent upon evidence documented in the patient’s medical record that the WOUND is improving in response to the WOUND CARE being provided. Since it is neither reasonable nor medically necessary to continue a given type of WOUND CARE in the absence of WOUND improvement, it is expected that the WOUNDs response to treatment will be documented in the medical record at least once every 30 days for each episode of WOUND treatment and made available to the contractor upon request.

Documentation of response requires measurements of the initial ulcer, measurements at the completion of at least four weeks of appropriate WOUND CARE and measurements immediately prior to placement and with each subsequent placement of the CTP.

Definitions per CPT:

Autografts/tissue cultured autografts: Include the harvest or application of an autologous skin graft.

CTP grafts: Include non-autologous human cellular and/or tissue products (e.g., dermal or epidermal, cellular and acellular, homograft or allograft), non-human cellular and/or tissue products (i.e., xenograft), and biological products (synthetic or xenogeneic) that are applied in a sheet over an open WOUND to augment WOUND closure or skin growth.

Indications:

Chronic WOUNDs are defined as WOUNDs that do not respond to standard WOUND treatment for at least a 30 day period during organized comprehensive conservative therapy.

For all WOUNDs, documentation (as outlined in the documentation requirements of the policy) and a comprehensive treatment plan, before initiation of a specialized WOUND therapy product is required.

For purposes of this LCD a Failed Response is defined as an ulcer or skin deficit that has failed to respond to documented appropriate WOUND-CARE measures, has increased in size or depth, or has not changed in baseline size or depth and has no indication that improvement is likely (such as granulation, epithelialization or progress towards closing).

Medicare covers application of CTPS to Ulcers or WOUNDs with Failed Response that are:

  • Partial- or full-thickness ulcers, not involving tendon, muscle, joint capsule or exhibiting exposed bone or sinus tracts, with a clean granular base unless the CTP package label indicates the CTP is approved for use involving tendon, muscle, joint capsule or exhibiting exposed bone or sinus tracts, with a clean granular base ;
  • Skin deficit at least 1.0 cm² in size;
  • Clean and free of necrotic debris or exudate;
  • Have adequate circulation/oxygenation to support tissue growth/WOUND healing as evidenced by physical examination (e.g., Ankle-Brachial Index (ABI) of no less than 0.60, toe pressure > 30mm Hg);
  • For diabetic foot ulcers, the patient’s medical record reflects a diagnosis of Type 1 or Type 2 Diabetes and also reflects medical management for this condition.


WOUND healing is impaired by the systemic use of tobacco. Therefore, ideally patients who have smoked will have ceased smoking or have refrained from systemic tobacco intake for at least 4 weeks during conservative WOUND CARE and prior to planned bioengineered skin replacement therapy.

Documentation (in the pre-service record) specifically addressing circumstances as to why the WOUND has failed to respond to standard WOUND CARE treatment of greater than 4 weeks and must reference specific interventions that have failed. Such record should include updated medication history, review of pertinent medical problems that may have occurred since the previous WOUND evaluation, and explanation of the planned skin replacement surgery with choice of CTP graft product. The procedure risks and complications should also be reviewed and documented. Documentation of smoking cessation counseling and cessation measures prescribed, if applicable, must also be documented in the patient's record.

Application of a CTP graft for lower extremity chronic WOUND (DFU and VLU) will be covered when the following conditions are met for the individual patient:

  • Presence of neuropathic ulcers and diabetic foot ulcer(s) having failed to respond to documented conservative WOUND-CARE measures of greater than four weeks, during which the patient is compliant with recommendations, and without evidence of underlying osteomyelitis or nidus of infection.
  • Presence of a venous stasis ulcer for at least 3 months but unresponsive to appropriate WOUND CARE for at least 30 days with documented compliance.
  • Presence of a full thickness skin loss ulcer that is the result of abscess, injury or trauma that has failed to respond to appropriate control of infection, foreign body, tumor resection, or other disease process for a period of 4 weeks or longer.

    In all WOUND management the ulcer must be free of infection and underlying osteomyelitis with documentation of the conditions that have been treated and resolved prior to the institution of CTP therapy. For purposes of this LCD, appropriate therapy includes, but is not limited to:
    • Control of edema, venous hypertension or lymphedema
    • Control of any nidus of infection or colonization with bacterial or fungal elements
    • Elimination of underlying cellulitis, osteomyelitis, foreign body, or malignant process
    • Appropriate debridement of necrotic tissue or foreign body (exposed bone or tendon)
    • For diabetic foot ulcers, appropriate non-weight bearing or off-loading pressure
    • For venous stasis ulcers, compression therapy provided with documented diligent use of multilayer dressings, compression stockings of > 20mmHg pressure, or pneumatic compression
    • Provision of WOUND environment to promote healing (protection from trauma and contaminants, elimination of inciting or aggravating processes)

Limitations:

Due to the propensity for misuse of CTP products, reimbursement may be made only when the medical record clearly documents that these products have been used in a comprehensive, organized WOUND management program. All listed products, unless they are specifically FDA-labeled or cleared for use in the types of WOUNDs being treated, will be considered not reasonable and necessary, therefore not eligible for reimbursement.

  • Partial thickness loss with the retention of epithelial appendages is not a candidate for grafting or replacement, as epithelium will repopulate the deficit from the appendages, negating the benefit of overgrafting
  • CTP grafts will be allowed for the episode of WOUND CARE in compliance with FDA guidelines for the specific product (see utilization guidelines) not to exceed 10 applications or treatments. In situations where more than one specific product is used, it is expected that the number of applications or treatments will still not exceed 10
  • Simultaneous use of more than one product for the episode of WOUND is not covered. Product change within the episode of WOUND is allowed, not to exceed the 10 application limit per WOUND per 12 week period of CARE.
  • Treatment of any chronic skin WOUND will typically last no more than twelve (12) weeks.
  • Repeat or alternative applications of skin substitute grafts are not considered medically reasonable and necessary when a previous full course of applications was unsuccessful. Unsuccessful treatment is defined as increase in size or depth of an ulcer or no change in baseline size or depth and no sign of improvement or indication that improvement is likely (such as granulation, epithelialization or progress towards closing) for a period of 4 weeks past start of therapy.
  • Retreatment of healed ulcers, those showing greater than 75% size reduction and smaller than .5 sq.cm, is not considered medically reasonable and necessary.
  • Skin substitute grafts are contraindicated and are not considered reasonable and necessary in patients with inadequate control of underlying conditions or exacerbating factors (e.g., uncontrolled diabetes, active infection, and active Charcot arthropathy of the ulcer extremity, vasculitis or continued tobacco smoking without physician attempt to effect smoking cessation).
  • CTP grafts are contraindicated in patients with known hypersensitivity to any component of the CTP graft (e.g., allergy to avian, bovine, porcine, equine products).
  • Repeat use of surgical preparation services in conjunction with CTP application codes will be considered not reasonable and necessary. It is expected that each WOUND will require the use of appropriate WOUND preparation code at least once at initiation of CARE prior to placement of the CTP graft.
  • Re-treatment within one (1) year of any given course of CTP treatment for a venous stasis ulcer or (diabetic) neuropathic foot ulcer is considered treatment failure and does not meet reasonable and necessary criteria for re-treatment of that ulcer with a CTP procedure.

CMS has guidance regarding other specialized WOUND treatment technology and specifically addresses platelet rich plasma systems (e.g., Autologet, Magellan); negative pressure WOUND therapy devices and electro-magnetic/ultrasound/mist therapies. They are not addressed in this LCD as their role in the treatment of the two major types of lower extremity WOUNDs discussed here is limited. Utilization remains at the provider’s discretion and must be reasonable and necessary. Note that combination therapy with any CTP will be considered not reasonable and necessary.

Please Note: Autologous Platelet Rich Plasma (PRP) systems used in the treatment of Chronic Non-Healing WOUNDs is not considered reasonable and necessary except as described in National Coverage Determination (NCD) for Blood-Derived Products for Chronic Non-Healing WOUNDs (270.3). Please refer to the NCD for coverage details.

As published in CMS IOM 100-08, Chapter 13, Section 13.5.1, in order to be covered under Medicare, a service shall be reasonable and necessary. When appropriate, contractors shall describe the circumstances under which the proposed LCD for the service is considered reasonable and necessary under Section 1862(a)(1)(A). Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is:

  • Safe and effective.
  • Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000, that meet the requirements of the Clinical Trials NCD are considered reasonable and necessary).
  • Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is:
    • Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member.
    • Furnished in a setting appropriate to the patient’s medical needs and condition.
    • Ordered and furnished by qualified personnel.
    • One that meets, but does not exceed, the patient’s medical needs.
    • At least as beneficial as an existing and available medically appropriate alternative.

Italicized or quoted material is excerpted from the American Medical Association, Current Procedural Terminology (CPT) codes.

Summary of Evidence

N/A

Analysis of Evidence (Rationale for Determination)

N/A

General Information

Associated Information
N/A
Sources of Information
N/A
Bibliography

Note: Some references sources are listed by request of “Skin Substitute” product stakeholders and should not be interpreted as CGS’s endorsement of any specific product.

Contractor is not responsible for the continued viability of websites listed.

 

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  30. Food and Drug Administration (FDA) [website]. Center for Devices and Radiological Health (CDRH). 510(k) Premarket Notification Database [search: K993948].. SIS WOUND Dressing II. January 6, 2000. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/k993948.pdf.
  31. Food and Drug Administration (FDA) [website]. Center for Devices and Radiological Health (CDRH). 510(k) Premarket Notification Database [search: K014129]. Promogran Matrix WOUND Dressing. February 14, 2002. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/k014129.pdf.
  32. Food and Drug Administration (FDA) [website]. Center for Devices and Radiological Health (CDRH). 510(k) Premarket Notification Database [search: K061407].
  33. Food and Drug Administration (FDA) [website]. Center for Devices and Radiological Health (CDRH). 510(k) Premarket Notification Database [search: K061711]. Oasis WOUND Matrix. July 19, 2006b. Available at http://www.accessdata.fda.gov/cdrh_docs/pdf6/K061711.pdf.
  34. Food and Drug Administration (FDA) [website]. Center for Devices and Radiological Health (CDRH). Premarket Approval (PMA) Database [search: H990002]. Epicel® (cultured epidermal autografts) – H990002. October 25, 2007. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/H990002a.pdf.
  35. Food and Drug Administration (FDA) [website]. Vaccines, Blood & Biologics. GRAFT JACKET Matrix, GRAFT JACKET XPRESS Scaffold and GRAFT JACKET Ulcer Repair Matrix. Updated April 30, 2009. Available at: www.fda.gov
  36. Foti C, Bonamonte D, Conserva A, Angelini G. Allergic contact dermatitis to regenerated oxidized cellulose contained in a matrix employed for WOUND therapy. Contact Dermatitis. 2007; 57(1):47-48.
  37. Franz MG, Robson MC, Steed DL, Barbul A, Brem H, Cooper DM, et al. Guidelines to aid healing of acute WOUNDs by decreasing impediments of healing. WOUND Repair Regen. 2008;16(6):723-748.
  38. Frykberg RG. Diabetic Foot Ulcers: Pathogenesis and Management. November 1, 2002. American Academy of Family Physicians (AAFP) [website]. Available at: http://www.aafp.org/afp/2002/1101/p1655.html.
  39. Gelfand JM, Hoffstad O, Margolis DJ, Surrogate Endpoints for the Treatment of Venous Leg Ulcers. The Journal of Investigative Dermatology. December 2002; 119(6): 1420-1425.
  40. Gentzkow GD, Iwasaki SD, Hershon KS, et al. Use of Dermagraft, a Cultured Human Dermis, to Treat Diabetic Foot Ulcers. Diabetes CARE, 1996;19(4):350-354, 1996.
  41. Genzyme Corporation [website]. Epicel® cultured epidermal autografts (CEA). HDE# 990002. Directions for Use. Revised October 2007. Available at: www.genzyme.com
  42. Greer, N., Foman, N., MacDonald, R., Dorrian, J., Fitzgerald, P., Rutks, I., and Wilt, T. (2013). Advanced WOUND CARE therapies for nonhealing diabetic, venous, and arterial ulcers. Annals of Internal Medicine, 159(8), 532-542.
  43. Guidance ComplianceRegulatoryInformation/ComplianceActivities/Enforcement/UntitledLetters/ucm091856.htm.
  44. Hanft J, Surprenant MS. Healing of Chronic Foot Ulcers in Diabetic Patients Treated with a Human Fibroblast-Derived Dermis. J Foot & Ankle Surgery, 2002;41(5):291-299.
  45. Harding KG, Morris HL, Patel GK. Science, medicine and the future: healing chronic WOUNDs. BMJ. 2002;324(7330):160-163.
  46. Hayes, Winifred S. Directory Report. Biological tissue-engineered skin substitutes for WOUND healing. January 17, 2013. Available at: http://www.hayesinc.com.
  47. Hayes, Winifred S. Directory Report. Biosynthetic tissue-engineered skin substitutes for WOUND healing. February 21, 2012. Available at: http://www.hayesinc.com.
  48. Hayes, Winifred S. Health Technology Brief. Oasis® WOUND matrix (Cook Biotech Inc.) for lower extremity ulcers. December 19, 2011. Available at: http://www.hayesinc.com.
  49. Hayes, Winifred S. Search and Summary. FlexHD® Acellular Hydrated Dermis (Ethicon Inc.). March 13, 2012. Available at: http://www.hayesinc.com.
  50. Hayes, Winifred S. Search and Summary. Grafix® (Osiris Therapeutics Inc.) living skin substitute allograft. July 6, 2011. Available at: http://www.hayesinc.com.
  51. Hayes, Winifred S. Search and Summary. Matristem® WOUND CARE matrix (ACell Inc.). October 25, 2011. Available at: http://www.hayesinc.com.
  52. Institute for Clinical Systems Improvement Website. Health CARE Protocol: Pressure ulcer prevention and treatment protocol. January 2012. Available at: http://www.icsi.org.
  53. Jimenez PA, Jimenez SE. Tissue and cellular approaches to WOUND repair. American Journal of Surgery, 2004;187:(5)
  54. Johnson & Johnson. Johnson & Johnson WOUND Management Announces Novel ORC/Collagen Matrix Dressing for Chronic WOUNDs [press release]. April 30, 2009. Available at: https://johnsonandjohnson.gcs-web.com/static-files/f1244d26-47f6-4ffc-a9e6-5c2af40967b3.
  55. Jones I, Currie L, Martin R. A guide to biological skin substitutes. Br J Plast Surg. 2002;55(3):185-193.
  56. Jones JE, Nelson EA, Al-Hity A, Skin grafting for venous leg ulcers (Review). The Cochrane Collaboration. 2013; 1: 1-62.
  57. Kakagia DD, Kazakos KJ, Xarchas KC, Karanikas M, Georgiadis GS, Tripsiannis G, et al. Synergistic action of protease-modulating matrix and autologous growth factors in healing of diabetic foot ulcers. A prospective randomized trial. J Diabetes Complications. 2007;21(6):387-391.
  58. Karr JC, Retrospective Comparison of Diabetic Foot Ulcer and Venous Statis Ulcer Healing Outcome Between a Dermal Repair Scaffold (PriMatrix) and a Bilayered Living Cell Therapy (Apligraf). Advances in Skin & WOUND CARE. March 2011; 24(3): 119-125.
  59. Kavros SJ, Acellular Fetal Bovine Dermal Matrix for Treatment of Chronic Ulcerations of the Midfoot Associated with Charcot Neuroarthropathy. Foot & Ankle Specialist. August 2012; 5(4): 230-234.
  60. Kavros SJ, Dutra T, Gonzalez-Cruz R, et al. The Use of Primatrix, a Fetal Bovine Acellular Dermal Matrix, in Healing Chronic Diabetic Foot Ulcers: A Prospective Multicenter Study. Advances in Skin & WOUND CARE. August 2014; 27(8): 356-362
  61. Kimmel HM, Robin AL, An Evidence-Based Algorithm for Treating Venous Leg Ulcers Utilizing the Cochrane Database of Systematic Reviews. WOUNDs. 2013; 25(9): 242-250.
  62. Kirsner R, Falanga V, Fivenson D, et al. Clinical Experience with a Human Skin Equivalent for the Treatment of Venous Leg Ulcers: Process and Outcomes. WOUNDs, 1999.
  63. LCDs and policies from other Medicare contractors and private insurers
  64. Landsman AS, Cook J, Cook E, et al. A Retrospective Clinical Study of 188 Consecutive Patients to Examine the Effectiveness of a Biologically Active Cryopreserved Human Skin Allograft (Theraskin) on the Treatment of Diabetic Foot Ulcers and Venous leg Ulcers. Foot & Ankle Spec. December 2010: 1-13.
  65. Li W, Dasgeb B, Phillips T, et al. WOUND-Healing Perspectives. Dermatologic Clinics, 2005;23:(2).
  66. Lionelli GT, Lawrence T, WOUND dressings. Surgical Clinics of North America, 2003;(83).
  67. Lullove E, Acellular Fetal Bovine Dermal Matrix in the Treatment of Nonhealing WOUNDs in Patients with Complex Comorbidities. Journal of the American Podiatric Medical Association. May/June 2012; 102(3): 233-239.
  68. Margolis DJ, Kantor J, Berlin JA. Healing of Diabetic Neuropathic Foot Ulcers Receiving Standard Treatment. Diabetes CARE, 1999;22:692-695.
  69. Margolis DJ, Hoffstad O, Gelfand J, et al. Surrogate End Points for the Treatment of Diabetic Neuropathic Foot Ulcers. Diabetes CARE, 2003;26(6):1696-1700.
  70. Marston WA, Hanft J, Norwood P, et al. The Efficacy and Safety of Dermagraft in Improving the Healing of Chronic Diabetic Foot Ulcers. Diabetes CARE, 2003;26(6):1701-1705.
  71. MD Consult Website. Leong M, Phillips L. WOUND dressings. In: Townsend Jr. A, Beauchamp R, Evers B, et al, eds. Townsend: Sabiston Textbook of Surgery, 19th ed. Philadelphia, PA: Elsevier; 2012. Available at: http://www.mdconsult.com.
  72. Medicare’s National Level II Codes HCPCS 2000, American Medical Association.
  73. Milliman CARE Guidelines® 15th Edition. Skin substitute, tissue-engineered. Available at: http://www.cgi.CAREguidelines.com/login-CAREweb.htm.
  74. Mostow EN, Haraway GD, Dalsing M, Hodde JP, King D; OASIS Venous Ulcer Study Group. Effectiveness of an extracellular matrix graft (OASIS WOUND Matrix) in the treatment of chronic leg ulcers: a randomized clinical trial. J Vasc Surg. 2005;41(5):837-843.
  75. Mostow EN, WOUND healing: A multidisciplinary approach for dermatologists. Dermatologic Clinics, 2003;21(2).
  76. National Guideline Clearinghouse. (2010). Association for the Advancement of WOUND CARE (AAWC) venous ulcer guideline. Agency for Healthcare Research and Quality. Retrieved from www.guideline.gov
  77. National Guideline Clearinghouse. (2010). Management of chronic venous leg ulcers: A national clinical guideline. Agency for Healthcare Research and Quality. Retrieved from www.guideline.gov
  78. Nemecek GM, Dayan AD. Safety evaluation of human living skin equivalents. Toxicol Pathol. 1999;27(1):101-103.
  79. Netscher DT, Clamon J. Smoking: adverse effects on outcomes for plastic surgical patients. Plast Surg Nurs. 1994 Winter;14(4):205-10.
  80. Niezgoda JA, Van Gils CC, Frykberg RG, Hodde JP. Randomized clinical trial comparing OASIS WOUND Matrix to Regranex Gel for diabetic ulcers. Adv Skin WOUND CARE. 2005;18(5 Pt 1):258-266.
  81. O’Donnell Jr. TF, Passman MA, Marston WA, et al. Management of venous leg ulcers: Clinical practice guidelines of the Society for Vascular Surgery® and the American Venous Forum. J Vasc Surg. 2014; 60: 3S-59S.
  82. Olin JW, Beusterien KM, Childs MB, Seavey C, McHugh L, Griffiths RI. Medical costs of treating venous stasis ulcers: evidence from a retrospective cohort study. Vasc Med. 1999;4(1):1-7.
  83. Organogenesis, Inc. Apligraf®. Prescribing Information. Revised April 2006. Available at: http://www.apligraf.com/professional/pdf/prescribing_information.pdf
  84. Pham HT, Rosenblum BI, Lyons TE, Giurini JM, Chrzan JS, Habershaw GM, et al. Evaluation of a human skin equivalent for the treatment of diabetic foot ulcers in a prospective, randomized, clinical trial. WOUNDs. 1999;11(4):79-86.
  85. Phillips TJ. New skin for old: developments in biological skin substitutes. Arch Dermatol. 1998;134(3):344-349.
  86. Phillips TJ, Machado F, Trout R, et al. Prognostic indicators in venous ulcers. J AM Acad Dermatol. 2000;43(4):627-630.
  87. Pittet D, Wyssa B, Herter-Clavel C, Kursteiner K, Vaucher J, Lew PD. Outcome of diabetic foot infections treated conservatively: a retrospective cohort study with long-term follow-up. Arch Intern Med. 1999;159(8):851-856.
  88. PriMatrix Dermal Repair Scaffold. June 29, 2006a. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf6/K061407.pdf.
  89. Robson MC, Barbul A. Guidelines for the best CARE of chronic WOUNDs. WOUND Repair Regen. 2006;14(6):647-648.
  90. Robson MC, Cooper DM, Aslam R, Gould LJ, Harding KG, Margolis DJ, et al. Guidelines for the treatment of venous ulcers. WOUND Repair Regen. 2006;14(6):649-662.
  91. Romanelli M, Dini V, Bertone M, Barbanera S, Brilli C. OASIS WOUND matrix versus Hyaloskin in the treatment of difficult-to-heal WOUNDs of mixed arterial/venous aetiology. Int WOUND J. 2007;4(1):3-7.
  92. Romanelli M, Kaha E, Stege H, Wnorowski JW, Vowden P, Majamaa H, et al. Effect of amelogenin extracellular matrix protein and compression on hard-to-heal venous leg ulcers: follow-up data. J WOUND CARE. 2008;17(1):17-23.
  93. Rossi M, Carpi A, Di Maria C, et al. Absent post-ischemic increase of blood flowmotion in the cutaneous microcirculation of healthy chronic cigarette smokers. Clinical Hemorheology and Microcirculation. 2007; 36: 163-171.
  94. Sanders L, Landsman AS, Landsman A, et al. A Prospective, Multicenter, Randomized, Controlled Clinical Trial Comparing a Bioengineered Skin Substitute to a Human Skin Allograft. Ostomy WOUND Management. September 2014; 60(9): 1-8.
  95. Serena TE, Carter MJ, Le LT, et al. A Multi-center Randomized Controlled Clinical Trial Evaluating the Use of Dehydrated Human Amnion/Chorion Membrane Allografts and Multi-layer Compression Therapy vs. Multi-layer Compression Therapy Alone in the Treatment of Venous Leg Ulcers. May 2014: 1-27.
  96. Shafritz R. Combining Bilayered Living Cell Therapy with Minimally Invasive Vein Surgery: Current Treatment Strategies for Venous Ulcers. Supplement to VDM.2007.
  97. Sheehan P, Jones P, Caselli A, et al. Percent Change in WOUND Area of Diabetic Foot Ulcers Over a 4-Week Period is a Robust Predictor of Complete Healing in a 12-Week Prospective Trial. Diabetes CARE. June 2003; 26(6): 1879-1882.
  98. Shores J. T., Hiersche M., Gabriel A., et al. Tendon coverage using an artificial skin substitute. Journal of Plastic, Reconstructive & Aesthetic Surgery. 2012; 65: 1544-1550.
  99. Silverstein P. Smoking and WOUND healing. Am J Med. 1992 Jul 15;93(1A):22S-24S.
  100. Snyder, DL, Sullivan, N, Schoelles, KM. Skin Substitutes for Treating Chronic Sounds, Technology Assessment Report, Project ID: HCPRO610, Final Report, December 18,2012. ECRI Institute (EPC) under contract to the Agency for Haelthcare Research and Quality (AHRQ), Rockville MD (Contract Number:HHSA 290-2007-10063).
  101. Snyder, RJ, Kirsner RS, Warriner, III RA, et al. Consensus Recommendations on Advancing the Standard of CARE for Treating Neuropathic Foot Ulcers in Patients with Diabetes. Ostomy WOUND Management. 2010; 56(suppl 4): S1-S24.
  102. Sørensen LT, Zillme R, Agren M, Ladelund S, Karlsmark T, Gottrup F. Effect of smoking, abstention, and nicotine patch on epidermal healing and collagenase in skin transudate. WOUND Repair Regen. 2009 May-Jun;17(3):347-53. doi: 10.1111/j.1524-475X.2009.00479.x.
  103. Steed DL, Attinger C, Colaizzi T, Crossland M, Franz M, Harkless L, et al. Guidelines for the treatment of diabetic ulcers. WOUND Repair Regen. 2006;14(6):680-692.
  104. Strauss NH, Brietstein RJ, WOUNDs. 2012; 24(11): 327-334.
  105. TEI Biosciences [website]. Primatrix™ Dermal Repair Scaffold. Product Summary. 2008. Available at: PriMatrix product information
  106. TheraSkin package insert
  107. U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH). Epicel (cultured epidermal autografts). Humanitarian Device Exemption No. H990002. Rockville, MD: FDA;Oct 25, 2007. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf//h990002a.pdf. Accessed January 22, 2013.
  108. U.S. Food and Drug Administration (FDA). Bilayer Matrix WOUND Dressing. 510(k) Summary. K021792. Integra LifeSciences Corp, Plainsboro, NJ. Rockville, MD: FDA; August 14, 2002. Available at: http://www.fda.gov/cdrh/pdf2/k021792.pdf.
  109. UpToDate® Website. Management of diabetic foot lesions. January 2012. Available at: https://www.uptodate.com/home/index.html.
  110. US Dept. of Health and Human Services Food and Drug Administration (CDER, CBER, CDRH). Guidance for Industry Chronic Cutaneous Ulcer and Burn WOUNDs – Developing Products for Treatment. June 2006.
  111. Veves A, Falanga V, Armstrong DG, et al. Graftskin, a Human Skin Equivalent, is Effective in the Management of Noninfected Neuropathic Diabetic Foot Ulcers. Diabetes CARE, 24(2):290-295, 2001
  112. Veves A, Sheehan P, Pham HT. A randomized, controlled trial of Promogran (a collagen/oxidized regenerated cellulose dressing) vs standard treatment in the management of diabetic foot ulcers. Arch Surg. 2002;137(7):822-827.
  113. Vowden P, Romanelli M, Peter R, Boström A, Josefsson A, Stege H. The effect of amelogenins (Xelma) on hard-to-heal venous leg ulcers. WOUND Repair Regen. 2006;14(3):240-246.
  114. Vowden P, Romanelli M, Price P. Effect of amelogenin extracellular matrix protein and compression on hard-to-heal venous leg ulcers. J WOUND CARE. 2007;16(5):189-195.
  115. Wallenstein S, Brem H, MD, Statistical analysis of WOUND-healing rates for pressure ulcers. American Journal of Surgery, 2004;188(1).
  116. Warriner RA 3rd, Cardinal M; TIDE Investigators. Human fibroblast-derived dermal substitute: results from a treatment investigational device exemption (TIDE) study in diabetic foot ulcers. Adv Skin WOUND CARE 2011 Jul;24(7):306-11.
  117. Waugh HV, Sherratt JA. Modeling the effects of treating diabetic WOUNDs with engineered skin substitutes. WOUND Repair Regen 2007 Jul-Aug;15(4):556-65
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  120. Wollina U, Schmidt WD, Krönert C, Nelskamp C, Scheibe A, Fassler D. Some effects of a topical collagen-based matrix on the microcirculation and WOUND healing in patients with chronic venous leg ulcers: preliminary observations. Int J Low Extrem WOUNDs. 2005;4(4):214-224.
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Revision History Information

Revision History DateRevision History NumberRevision History ExplanationReasons for Change
02/03/2022 R21

R21

Revision Effective: 02/03/2022

Revision Explanation: Moved information in sources of information ot bibliography and corrected link for #104 in bibliography.

  • Other (Corrected link)
10/31/2019 R20

R20

Revision Effective: 08/25/2020

Revision Explanation: Annual Review, no changes

08/25/2020:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
10/31/2019 R19

R19

Revision Effective: 09/23/2019

Revision Explanation: Removed codes left in policy text in coverage and limitations section when coding was moved to billing and coding article A56696. Move the information concerning documentation and utilization requirements from the associated information section of the policy and placed into the billing and coding article.

10/22/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Migrating associate information)
09/23/2019 R18

R18

Revision Effective: 09/23/2019 Revision Explanation: Annual review, no changes made.

09/23/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual review, no changes)
09/19/2019 R17

R17

Revision Effective: 09/19/2019 Revision Explanation: Converted policy into new policy template that no longer includes coding section based on CR 10901. For Approval, no changes.

09/13/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Revisions Due To Code Removal
09/19/2019 R16

R16

Revision Effective: 09/19/2019 Revision Explanation: Converted policy into new policy template that no longer includes coding section based on CR 10901.

09/12/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Revisions Due To Code Removal
07/11/2019 R15

R15

Revision Effective: N/A

Revision Explanation: Annual review, no changes made.

 DATE (08/27/2019): At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy

  • Other (Annual Review)
07/11/2019 R14

R14

Revision Effective: 07/11/2019

Revision Explanation: All coding information removed based on CR 10901.

 

DATE (07/05/2019): At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy

  • Other (Code Migration)
06/06/2019 R13

R13

Revision Effective: 6-6-2019

Revision Explanation: Added Q4203 to group two codes that are covered.

 

DATE (05/29/2019): At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy

  • Reconsideration Request
01/01/2019 R12

R12

Revision Effective: 01/01/2019

Revision Explanation: Added Q4188 to group two codes that are covered.

 

DATE (03/18/2019): At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy

  • Reconsideration Request
01/01/2019 R11

R11

Revision Effective: N/A

Revision Explanation: Corrected link to article for Johnson & Johnson announcement for ORC Matrix in Sources of information section

 

2/26/2019: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy

  • Other (Corrected link)
01/01/2019 R10

R10

Revision Effective: 01/01/2019

Revision Explanation: During annual HCPCS update the following codes were deleted Q4131 and Q4172 and replaced with codes Q4186, Q4187, Q4195-Q4197.

 

12/20/2018: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy

  • Revisions Due To CPT/HCPCS Code Changes
10/01/2018 R9

R9

Revision Effective: 10/01/2018

Revision Explanation: Added Q4166 to group two codes that are covered.

 

DATE (11/13/2018): At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy

  • Request for Coverage by a Practitioner (Part B)
01/01/2018 R8

R8

Revision Effective: N/A

Revision Explanation: Annual review no changes made.

 

DATE (08/13/2018): At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy

  • Other (Annual Review)
01/01/2018 R7

R7
Revision Effective: N/A
Revision Explanation: Correct links that were broken for PriMatirx, apligraf, Genzyme, and graft jacket

 

DATE (05/25/2018): At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

 

  • Other (Broken links)
01/01/2018 R6

R6
Revision Effective: 01/01/2018
Revision Explanation: Added Q4177 and Q4178 to list of products that meet FDA regulatory requirements.

 

DATE (05/10/2018): At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Reconsideration Request
01/01/2018 R5

R5
Revision Effective: 01/01/2018
Revision Explanation: Added Q4145 to list of products.

 

DATE (03/19/2018): At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Reconsideration Request
01/01/2017 R4

R4
Revision Effective: N/A
Revision Explanation: Annual review no changes made.

 

DATE (08/28/2017): At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.


  • Other (Annual Review)
01/01/2017 R3 R2
Revision Effective: 01/01/2017
Revision Explanation: Added Q4173, Q4174, Q4175, and Q4169 as covered products.
  • Revisions Due To CPT/HCPCS Code Changes
01/01/2017 R2 R2
Revision Effective: 01/01/2017
Revision Explanation: C9349 was replaced with Q4172 during annual HCPCS update.
  • Revisions Due To CPT/HCPCS Code Changes
10/10/2016 R1 R1
Revision Effective: N/A
Revision Explanation: Corrected typographical error in title of policy.
  • Typographical Error

Associated Documents

Attachments
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Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
08/26/2022 09/01/2022 - N/A Currently in Effect View
01/28/2022 02/03/2022 - 08/31/2022 Superseded You are here
08/25/2020 10/31/2019 - 02/02/2022 Superseded View
10/22/2019 10/31/2019 - N/A Superseded View
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