Novitas MAC A and MAC B Policy Primer 1,2 for Apligraf

Transcription

1 Novitas MAC A and MAC B Policy Primer 1,2 for Apligraf DC, DE, MD, NJ & PA Counties of Arlington and Fairfax in Virginia and the city of Alexandria in Virginia are covered under this policy primer Effective Date: 1/1/2012 Indications VSU 3 The ulcer(s) is of at least four (4) weeks in duration. The treatment is specific to non-infected partial or full-thickness skin ulcers, at least 1.0 cm 2 in size, due to clinically documented venous insufficiency (venous insufficiency should be objectively documented either by history of previous deep venous thrombosis in the index leg, or objective documentation of valvular reflux by duplex ultrasound, venography, or air/photo plethysmography). Adequate circulation/oxygenation is supported by documented physical examination and an Ankle-Brachial Index (ABI) of no less than 0.65 DFU 4 The ulcer is of at least three (3) weeks in duration. The treatment is specific to non-infected full thickness foot ulcers, at least 1.0 cm 2 in size, due to clinically documented diabetic neuropathy (type 1 or type 2 diabetes should be objectively documented as well as the current medical management for the diabetes. The ulcer is located on the surface of the foot and is free of infection, tunnels, and tracts. Additionally, the ulcer must be free of cellulitis, eschar, or obvious necrotic material as this will interfere with the device adherence and wound healing. The ulcer extends through the dermis but it does not involve the tendon, muscle, capsule or have bone exposure. Limitations Because application of Apligraf, and Dermagraft, as well as any subsequently accepted similar product, is considered a physician service, these products must be applied by a physician or a qualified licensed Non-Physician Practitioner and not by non-advanced practice nurses, therapists or medical assistants. The application of Apligraf is limited to clinicians who are highly skilled in wound care management and have experience in the use of HSE for the treatment of wounds. The success of the procedure is somewhat dependent on the skill of the performing provider; therefore, the provider may be subject to a post payment peer review in order to verify his/her qualifications. Note: The liberalization of this provision of the LCD to allow clinicians other than physicians (MD, DO, and DPMs), as well as physicians (MD, DO, and DPMs) who are highly skilled in wound care management and have experience in the use of HSE for the treatment of wounds, is retroactive to 12/13/2008. Prior to Apligraf application, it is expected the medical record documentation will contain evidence that the conservative measures have failed, or the medical record supports that the ulcer is so clinically severe that it requires immediate, aggressive therapy. The medical record

2 Novitas MAC A and MAC B Policy Primer 1,2 for Apligraf (continued) must reflect that the ulcer has failed to decrease in size and depth, or that there has been no change in baseline size or depth with no sign of improvement, or no indication that improvement is likely. A single application of Apligraf may be all that is required to affect the wound healing in those wounds that are likely to improve by this therapy. The use of additional applications if less than 50% take is observed, is limited to a total of four additional applications for the same ulcer (so a total of five). Additional applications beyond this for one year are generally not considered reasonable and necessary. Retreatment within one year following the last successful Apligraf application is generally not considered reasonable and necessary. Retreatment of an ulcer following the unsuccessful treatment where is consisted of two failed Apligraf applications is not considered reasonable and necessary. Documentation All documentation must be maintained in the patient s medical record and available to the contractor upon request. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service(s)). The record must include the physician or non-physician practitioner responsible for and providing the care of the patient. The submitted medical record should support the use of the selected ICD-9-CM code(s). The submitted CPT/HCPCS code should describe the service performed. The medical record should clearly reflect the post-application care and the effectiveness of the device. Product Wastage Documentation Requirements Any amount of wasted material must be clearly documented in the medical record with the following information: Date, time and location of ulcer treated. Approximate amount of product unit used. Approximate amount of product unit discarded. Reason for the wastage. Manufacturer s serial/lot/batch or other unit identification number of graft material. When manufacturer does not supply unit identification, record must document such. Coding Product Wastage (JW Modifier) HCPCS modifier: JW may be used to indicate the product amount discarded and not used on any patient. The amount used must be on a separate detail line from the amount wasted, which is indicated with modifier -JW (when applicable). Modifier -JW would not be used for claims billing when the product code description already includes the amount administered along with the amount wasted.

3 Novitas MAC A and MAC B Policy Primer 1,2 for Apligraf (continued) Coding CPT/HCPCS 5 Q4101: Apligraf, per square centimeter Application Codes for Leg 15271: Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area 15272: Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure) 15273: Application of skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area 15274: Application of skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; each additional 100 sq cm wound surface area, or part therof (List separately in addition to code for primary procedure) Application Codes for Foot 15275: Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area 15276: Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure) 15277: Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area 15278: Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; each additional 100 sq cm wound surface area, or part therof (List separately in addition to code for primary procedure) K Modifier When application of the material is accomplished by the use of sutures, staples, steri-strips, or other techniques per product instruction, report the applicable CPT procedure code, the applicable HCPCS Q code for the product, and modifier K. Use of the modifier K indicates that the documentation in the medical record supports the use of a method of affixing the HSE beyond a dressing only. That documentation is to be retained in the medical record and submitted to the contractor upon request. ICD-9-CM VSU: 454.0, 454.2, , DFU: , Source: 2 This document is for informational purposes only. Use of this information does not guarantee coverage or payment for these services by Medicare or other payors. Physicians and other providers should use independent judgment when selecting codes that most appropriately describe the services provided to a patient. Physicians and hospitals are solely responsible for compliance with Medicare and other payors laws, rules, and requirements. 3 VSU = Venous Stasis Ulcer. 4 DFU = Diabetic Foot Ulcer. 5 CPT American Medical Association. All Rights Reserved.

4 2014 Novitas Medicare Apligraf Sample UB-04 Claim Form Anytown Hospital 123 Medical Drive Anytown, NJ HIC A Maple Avenue Anytown NJ All dates should be in eight digit format. Jane Smith 111 Maple Avenue Anytown, NJ Apligraf Q4101 K Apligraf product wastage Q4101 K JW Application, first 25 sq cm K Application, each additional 25 sq cm K Enter appropriate revenue codes for all services provided. Revenue code 636 should be used when billing for Apligraf and should be used based on the size of the wound. For example, a LEG wound measuring 30 sq cm, would be billed using (first 25 sq cm or less) and (each additional 25 sq cm or part thereof). Apligraf is supplied in 44 sq cm and is for single use. This example is for a 30 sq cm wound with 14 sq cm coded for wastage with the JW modifier. Medicare A xxx.xx VSU: 454.0, 454.2, , DFU: ,

5 2014 Novitas Medicare Apligraf Sample CMS-1500 Claim Form Physician Services in an Outpatient Setting A Any Street 123 Any Street Anytown NY Anytown NY (973) SIGNATURE ON FILE xxx xx xxx xx VSU: 454.0, 454.2, , DFU: , K K and should be used based on the size of the wound. For example, a LEG wound measuring 30 sq cm, would be billed using (first 25 sq cm or less) and (each additional 25 sq cm or part thereof)

6 2014 Novitas Medicare Apligraf Sample CMS-1500 Claim Form Physician Services in an Office Setting A Any Street 123 Any Street Anytown NY Anytown NY (973) SIGNATURE ON FILE xxx xx xxx xx VSU: 454.0, 454.2, , DFU: , Q4101 K Q4101 K JW K K and should be used based on the size of the wound. For example, a LEG wound measuring 30 sq cm, would be billed using (first 25 sq cm or less) and (each additional 25 sq cm or part thereof). Apligraf is supplied in 44 sq cm and is for single use. This example is for a 30 sq cm wound with 14 sq cm coded for wastage with the JW modifier

7 Model Documentation Form for Novitas JL for Apligraf Pretreatment: 1. Duration of ulcer (DFU: 3 weeks, VSU: greater than 1 month) weeks 2. Location of ulcer 3. Document failure to respond to conservative measures (a failed response is defined as an ulcer that has increased in size or depth and no indication that improvement is likely e.g., epithelial in growth and progression towards closure) 4. If Apligraf is being utilized for an immediate need (without a history of failure to respond to conservative measures) document whether the ulcer is so clinically severe that it requires immediate, aggressive therapy. 5. Document measurement of the ulcer at baseline, following cessation of conservative management. 6. Describe treatment of the underlying disease process contributing to the ulcer 7. Indicate appropriate patient diagnosis codes: VSU: 454.0, 454.2, , DFU: , Document whether wound is clean, free of cellulitis, infection, tunnels and tracts, eschar or any necrotic material 9. For DFU, document whether ulcer extends through the dermis but without tendon, muscle, capsule or bone exposure. 10. For DFU, document the neuropathy. Continued on next page > This document is for informational purposes only. Use of this information does not guarantee coverage or payment for these services by Medicare or other payors. LCDs are updated by Medicare and Medicare contractors on a regular basis. Physicians and other providers should regularly refer to the applicable Medicare local coverage determinations (LCDs) for complete information on medical necessity documentation requirements. Physicians, providers and hospitals are solely responsible for compliance with Medicare and other payors laws, rules, and requirements.

8 11. Document patient s arterial blood supply as evidenced by ABI (ABI of 0.65 or greater) 12. For venous insufficiency ulcer, document venous insufficiency (either by history of previous deep venous thrombosis in the index leg, or objective documentation of valvular reflux by duplex ultrasound, venography, or air/photo plethysmography) 13. Document that the patient is competent, and/or has the support services required to participate in follow-up care associated with the treatment of the wound following Apligraf application. Treatment: 14. Document measurement of ulcer (width and length or circumference and depth) immediately prior to application of Apligraf sq cm 15. Document whether this is an initial application of Apligraf or a reapplication. (Apligraf is limited to 5 applications per ulcer.) 16. For Apligraf reapplications, document whether less than 50% take is observed 17. Document how Apligraf was fixated to the wound (Use of the K modifier indicates that the documentation supports the use of a method of affixing Apligraf beyond a dressing only). 18. Document the name of the physician treating the patient s systemic disease and how the patient s systemic disease is being treated/monitored in order to insure adequate healing of the wound site. 19. Describe post-application patient care Product Wastage Documentation Requirements: 20. Date: 21. Time: 22. Location of ulcer: 23. Approximate amount of product unit used: 24. Approximate amount of product unit discarded: 25. Reason for the wastage: 26. Manufacture s serial/lot/batch number Wastage example of 30sq cm wound that was treated with Apligraf (Apligraf is supplied in 44 sq cm) Q4101 K - 30units Q4101 K JW - 14 units This document is for informational purposes only. Use of this information does not guarantee coverage or payment for these services by Medicare or other payors. LCDs are updated by Medicare and Medicare contractors on a regular basis. Physicians and other providers should regularly refer to the applicable Medicare local coverage determinations (LCDs) for complete information on medical necessity documentation requirements. Physicians, providers and hospitals are solely responsible for compliance with Medicare and other payors laws, rules, and requirements.