The Centers for Medicare & Medicaid Services (CMS) has recently announced that the Medicare Administrative Contractors (MACs) issued the collaborative proposed local coverage determination (LCD) “Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers (DFUs) and Venous Leg Ulcers (VLUs)”. The reason for proposing the new LCD was to standardize coverage decisions across all MACs.
The key points of the proposed LCD are listed below. CMS is accepting written comments until June 8, 2024, and is holding public listening sessions in May, 2024.
This is a critical window to make your professional voice heard in the policymaking process. As a wound care clinician, your expertise and insights are crucial in shaping upcoming changes.
Your participation is vital. Join the conversation and help shape the future of wound care for Medicare beneficiaries across the nation.
Key Points of the Proposed Unified LCD and Accompanying Billing & Coding Article
Updates to the coverage requirements for skin substitute grafts/CTP
Limitations (per ulcer episode of care)
Notable proposed updates to the items that are considered not reasonable and necessary (and therefore not covered) include:
- Greater than 4 applications of a skin substitute graft/CTP within the episode of skin replacement therapy (defined as 12 weeks from the first application of a skin substitute graft/CTP). In exceptional cases in which 4 applications is not sufficient for adequate wound healing, additional applications may be considered with documentation that includes progression of wound closure under current treatment plan and medical necessity for additional applications.
- Application of a skin substitute graft/CTP beyond 12-weeks per episode within the episode of skin replacement therapy. In exceptional cases in which 12 weeks is not sufficient for adequate wound healing, additional duration of care may be considered with documentation demonstrating progression of wound closure under current treatment plan and benefit expected from additional applications.
- Repeat applications of skin substitute graft/CTP when a previous application was unsuccessful. Unsuccessful treatment is defined as increase in size or depth of an ulcer, no measurable change from baseline, and no sign of improvement or indication that improvement is likely (such as granulation, epithelialization, or progress towards closure). Unsuccessful therapy also includes reoccurrence of the ulcer in the same location within 12 months from initial application.
- All liquid or gel skin substitute products or CTPs for ulcer
According to CMS' analysis of the existing evidence, most ulcers would be expected to close within a maximum of 4 applications and 12 weeks. Ulcer size and immune compromise has been cited by expert opinion as grounds for additional applications secondary to extended time to heal. Therefore, CMS added an exception to the policy to accommodate patients who have documented benefit of wound healing with the skin substitute graft use may receive additional applications or duration of care with documented clinical indications. The additional application or extension would be identified with a modifier and documentation in the medical record will be required to explain the clinical rationale for the exception and may be subject to medical review.
The accompanying Billing and Coding Articles clarify the utilization parameters and the documentation needed to support medical necessity of applications beyond the maximum number allowed (4) within the episode of care.
Utilization Parameters
- A maximum of 4 skin substitute graft/CTP applications per ulcer will be allowed for the episode of skin replacement surgery (defined as 12-weeks from the first application of a skin substitute graft/CTP). Product change within the episode of skin replacement surgery may be appropriate. When more than 1 specific product is used during the 12-week period, it is expected that the total number of applications or treatments will still not exceed 4.
- More than 4 applications of a skin substitute graft/CTP in a 12-week period or extension of treatment beyond 12 weeks must be appended with a KX modifier.
Documentation
Documentation must support medical necessity for the use of additional applications or time and include:
- Explanation of why extended time or additional applications is medically necessary for the specific patient
- That the current treatment plan has resulted in wound healing and expectation that the wound will continue to heal with this plan. Documentation should include estimated time for extended treatment and number of additional applications anticipated and plan of care if healing is not achieved as planned.
- What modifiable risk factors, such as diabetes control, are being approached to improve likelihood of healing
- For venous leg ulcers, it is expected that appropriate consultation and management be obtained for the diagnosis and stabilization of any venous related disease
Updates on ICD-10-CM codes that support medical necessity
The Billing and Coding Article clarifies which ICD-10-CM codes would support medical necessity. Refer to 'Table ICD-10-CM Codes that Support Medical Necessity > Group 1' Codes in the unified Billing and Coding Articles (see links to Articles in section 'Next Steps' below)
Diabetes codes*
- E08.621
- E09.621
- E10.621
- E11.621
- E13.621
Varicose veins*
- I83.011 - I83.018
- I83.021 - I83.025, I83.028
- I83.211 - I83.218
- I83.221- I83.218, I83.228
- I83.011 - I83.018
Post-thrombotic syndrome*
- I87.011 - I87.013
- I87.031- I87.033
Chronic venous hypertension*
- I87.311 - I87.313
- I87.331- I87.333
Non-pressure chronic ulcer codes
- L97.111, L97.112
- L97.121, L97.122
- L97.211, L97.212
- L97.221, L97.222
- L97.311, L97.312
- L97.321, L97.322
- L97.411, L97.412
- L97.421, L97.422
- L97.511, L97.512
- L97.521, L97.522
- L97.811, L97.812
- L97.821, L97.822
*Dual diagnosis requirement: When reporting the * codes listed above, 1 of the L97 ICD-10-CM codes (L97.XX) must also be reported to identify the site and severity of the ulcer.
Updates to the CTP brands covered by CMS
Among the CTP currently marketed in the US, only 15 would be covered and more than 209 would be non-covered by CMS. Refer to Table 'CPT/HCPCS Codes > Group 2 and Group 3' Codes in the unified Billing and Coding Articles (see links to Articles in section 'Next Steps' below)
- According to the LCDs, “to be considered reasonable and necessary for coverage, each skin substitute/CTP must demonstrate net positive health outcome(s) in a well-defined patient population. Specifically, wound closure attributable to the individual product(s) proven in clinical trials with a meaningful degree of certainty is required. Therefore, a limited coverage position for specific products in specific patient populations has been taken to facilitate access to skin substitute graft/CTP products with clinically meaningful net-positive clinical outcome(s) validated by evidentiary review.”
- Covered CTPs would be:
- Q4101 APLIGRAF, PER SQUARE CENTIMETER
- Q4102 OASIS WOUND MATRIX, PER SQUARE CENTIMETER
- Q4105 INTEGRA DERMAL REGENERATION TEMPLATE (DRT) OR INTEGRA OMNIGRAFT DERMAL REGENERATION MATRIX, PER SQUARE CENTIMETER
- Q4106 DERMAGRAFT, PER SQUARE CENTIMETER
- Q4107 GRAFTJACKET, PER SQUARE CENTIMETER
- Q4110 PRIMATRIX, PER SQUARE CENTIMETER
- Q4121 THERASKIN, PER SQUARE CENTIMETER
- Q4122 DERMACELL, DERMACELL AWM OR DERMACELL AWM POROUS, PER SQUARE CENTIMETER
- Q4124 OASIS ULTRA TRI-LAYER WOUND MATRIX, PER SQUARE CENTIMETER
- Q4128 FLEX HD, OR ALLOPATCH HD, PER SQUARE CENTIMETER
- Q4133 GRAFIX PRIME, GRAFIXPL PRIME, STRAVIX AND STRAVIXPL, PER SQUARE CENTIMETER
- Q4151 AMNIOBAND OR GUARDIAN, PER SQUARE CENTIMETER
- Q4159 AFFINITY, PER SQUARE CENTIMETER
- Q4186 EPIFIX, PER SQUARE CENTIMETER
- Q4187 EPICORD, PER SQUARE CENTIMETER
Why Your Input is Essential
- Direct Impact: Your clinical experience treating DFUs and VLUs gives you a unique perspective on what interventions are most effective. This is your opportunity to ensure that Medicare coverage supports the best patient outcomes.
- Influence Healthcare Policy: By participating in the consultation process, you have the power to influence policy to better support clinical needs and patient care.
How to Get Involved
- Comment Period: You have until June 8, 2024, to submit your comments on the proposed LCD. This is a critical window to make your professional voice heard in the policymaking process.
- Public Listening Sessions: CMS and the MACs are hosting listening sessions in May. These sessions are an excellent opportunity for direct dialogue and to share your insights and concerns.
- Accessibility: If you're unable to attend a session in person, session recordings will be available on the MAC websites, ensuring you can stay informed and involved.
Next Steps
Click on the links below to visit your local MAC’s LCD to submit your comments and register for the public listening sessions. This is more than just a policy update - it’s a chance to advocate for the treatments your patients need to lead healthier lives.
- CGS Administrators:
- Proposed LCD: DL39756 (Comments End 06/08/2024)
- Article: not found
- First Coast Service Options, Inc. (FCSO)
- National Government Services, Inc. (NGS)
- Noridian
- Novitas
- Palmetto
- WPS
About the Authors
Elaine Horibe Song, MD, PhD, MBA
Dr. Song is a Co-Founder and Chief Executive Officer of WoundReference, Inc., a clinical and reimbursement decision support & telemedicine platform for wound care and hyperbaric clinicians. With a medical, science and business background, Dr. Song previously served as medical director for a regenerative medicine-focused biotech company in California, and for a Joint Commission International-accredited hospital network. Dr. Song also served as a management consultant for Kaiser Permanente, practiced as a plastic surgeon in private practice and academia, and conducted bench and clinical research in wound healing, microsurgery and transplant immunology. Dr. Song holds a position as Affiliate Professor, Division of Plastic Surgery, Federal University of Sao Paulo, and is a volunteer, Committee Chair of the Association for the Advancement of Wound Care. She has authored more than 100 scientific publications, book chapters, software registrations and patents.
Tiffany Hamm, BSN, RN, CWS, ACHRN, UHMSADS
An Advanced Certified Hyperbaric Registered Nurse and Certified Wound Specialist with expertise in billing, coding and reimbursement specific to hyperbaric medicine and wound care services. UHMS Accreditation Surveyor and Safety Director. Principal partner of Midwest Hyperbaric LLC, a hyperbaric and wound consultative service. Tiffany received her primary and advanced hyperbaric training through National Baromedical Services in Columbia South Carolina. In 2021, Tiffany received the UHMS Associate Distinguished Service Award. "This award is presented to individual Associate member of the Society whose professional activities and standing are deemed to be exceptional and deserving of the highest recognition we can bestow upon them . . . who have demonstrated devotion and significant time and effort to the administrative, clinical, mechanical, physiological, safety, technical practice, and/or advancement of the hyperbaric community while achieving the highest level of expertise in their respective field. . . demonstrating the professionalism and ethical standards embodied in this recognition and in the UHMS mission.”
Mike White, MD, UHM, MMM, CWS
Dr. White is boarded in family medicine, undersea and hyperbaric medicine, and is a certified wound specialist.
Formerly serving as Chief Medical Officer for Universal Medical Management and later at Hendry Regional Medical Center in Clewiston, FL. He currently servest as the Medical Director at the Palmetto Baptist Advanced Wound Care Center in Columbia, SC.
Dr. White received his Doctorate of Medicine from Marshall University and completed a Masters of Medical Management from Tulane University in 2009. He has been with Wound Care Education Partners since 2011.
Jeff Mize, RRT, CHT, UHMSADS
With over four decades of healthcare experience, Jeff currently holds the position of Principal Partner at Midwest Hyperbaric LLC and the Co-founder and Chief Clinical Officer of Wound Reference.
Jeff has excelled in critical care throughout his career, devoting almost a decade as a Flight Respiratory Therapist/Paramedic for the Spirit of Kansas City Life Flight. In 1993, Jeff transitioned into the field of Hyperbaric Medicine and Wound Care, where he committed 21 years of his career to serving as the Program Director for a 24/7 Level 1 UHMS Accredited facility with Distinction. In this role, he continued to provide patient care while overseeing all administrative, clinical, and daily operations within the Wound Care and Hyperbaric Facility.
Jeff is a Registered Respiratory Therapist and a Certified Hyperbaric Technologist (CHT). He has also undergone training as a UHMS Safety Director and a UHMS Facility Accreditation Surveyor.
Jeff currently serves as a member of the UHMS Accreditation Council, the UHMS Accreditation Forum Expert Panel, and the UHMS Safety Committee. Additionally, he is an esteemed member of the NFPA 99 Hyperbaric and Hypobaric Facilities Technical Standards Committee.
Jeff's dedication to the field has earned him numerous prestigious awards. In 2010, he received the Gurnee Award, which honored his outstanding contributions to undersea and hyperbaric medicine. Three years later, in 2013, he was awarded the Paul C. Baker Award for his commitment to Hyperbaric Oxygen Safety Excellence. Most recently, in 2020, Jeff was honored with "The Associates Distinguished Service Award (UHMSADS)," a recognition reserved for exceptional Associate members of the Society who have demonstrated exceptional professionalism and contributions deserving of the highest accolades.
