(Medicare National Coverage Determinations Manual)

The FDA has approved one lymphocyte immune globulin preparation for marketing, lymphocyte immune globulin, anti -thymocyte globulin (equine).  This drug is indicated for the management of allograft rejection episodes in renal transplantation.  It is covered under Medicare when used for this purpose.  Other forms of lymphocyte globulin preparation which the FDA approves for this indication in the future may be covered under Medicare.   260.8 - Reserved  (Rev. 1, 10- 03-03) Reserved   260.9 - Heart Transplants  (Rev. 95; Issued:  09- 10-08; Effective Date:  05 -01-08; Implementation Date: 12 -01-08)  A.  General   Cardiac transplantation is covered under Medicare when performed in a facility which is approved by Medicare as meeting institutional coverage criteria. (See CMS Ruling 87- 1.)  B.  Exceptions   In certain limited cases, exceptions to the criteria may be warranted if there is justification and if the facility ensures our objectives of safety and efficacy.  Under no circumstances will exceptions be made for facilities whose transplant programs have  been in existence for less than 2 years, and applications from consortia will not be approved.   Although consortium arrangements will not be approved for payment of Medicare heart transplants, consideration will be given to applications from heart transplant facilities that consist of more than one hospital where all of the following conditions exist :   The hospitals are under the common control or have a formal affiliation arrangement with each other under the auspices of an organization such as a university or a legally constituted medical research institute; and    The hospitals share resources by routinely using the same personnel or services in their transplant programs.  The sharing of resources must be supported by the submission of operative notes or other information that documents the routine use of the same p ersonnel and services in all of the individual hospitals.  At a minimum, shared resources means:    The individual members of the transplant team, consisting of the cardiac transplant surgeons, cardiologists and pathologists, must practice in all the hospitals and it can be documented that they otherwise function as members of the transplant team; and    The same organ procurement organization, immunology, and tissue -typing services must be used by all the hospitals;    The hospitals submit, in the manner required (Kaplan- Meier method) their individual and pooled experience and survival data; and    The hospitals otherwise meet the remaining Medicare criteria for heart transplant facilities; that is, the criteria regarding patient selection, patient management, program commitment, etc.   C.  Pediatric Hospitals   Cardiac transplantation is covered for Medicare beneficiaries when performed in a pediatric hospital that performs pediatric heart transplants if the hospital submits an application which CMS approves as documenting that:    The hospitals pediatric heart transplant program is operated jointly by the hospital and another facility that has been found by CMS to meet the institutional coverage criteria in CMS Ruling 87- 1;   The unified program shares the same transplant surgeons and quality assurance program (including oversight committee, patient protocol, and patient selection criteria); and    The hospital is able to provide the specialized facilities, services, and personnel that are required by pediatric heart transplant patients.   D.  Follow -Up Care   Follow -up care required as a result of  a covered heart transplant is covered, provided such services are otherwise reasonable and necessary.  Follow -up care is also covered for patients who have been discharged from a hospital after receiving a noncovered heart transplant.  Coverage for follow -up care would be for items and services that are reasonable and necessary, as determined by Medicare guidelines.  (See the Medicare Benefit Policy Manual, Chapter 16, General Exclusions From Coverage, 180.)   E.  Immunosuppressive Drugs   See the Medicare Claims Processing Manuals, Chapter 17, Drugs and Biologicals, 80.3.1 and, Chapter 8, Outpatient ESRD Hospital, Independent Facility, and Physician/Supplier Claims, 120.1.  F.  Artificial Hearts   Medicare covers ventricular assist devices (VAD) and artificial hearts when implanted under the coverage criteria stated in 20.9 of this manual (NCD Manual 100- 03).  (This NCD last reviewed April 2008.)   260.10 - Heartsbreath Test for Heart Transplant Rejection (Effective December 8, 2008)  (Rev.99, Issued: 02- 13-09, Effective: 12 -08-08, Implementation: 04- 06-09)  A. General   The Heartsbreath test is a Food and Drug Administration- approved Humanitarian Use Device for use only as an adjunct to the endomyocardial biopsy to detect grade 3 heart transplant rejection in patients who have had a heart transplant within the last year a nd an endomyocardial biopsy within the prior month.  The test involves collecting breath samples from the patient and analysis of the samples performed in a laboratory.  These test results are then compared to endomyocardial biopsy findings and the results  are provided to the clinician shortly thereafter.   B. Nationally Covered Indications   N/A  C. Nationally Non -Covered Indications   Effective for services performed on or after December 8, 2008, the Centers for Medicare & Medicaid Services has determined that the evidence does not adequately define the technical characteristics of the test nor demonstrate that Heartsbreath testing to p redict heart transplant rejection improves health outcomes in Medicare beneficiaries.  Thus, we conclude that the Heartsbreath test is not reasonable and necessary under section 1862(a)(1)(A) of the Social Security Act and is non- covered.   D. Other  N/A  (This NCD last reviewed December 2008.)   270 - Wound Treatment  (Rev 7, 03- 19-04)  270.1 - Electrical Stimulation (ES) and Electromagnetic Therapy for the Treatment of Wounds   (Effective July 1, 2004)  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  Electrical stimulation (ES) and electromagnetic therapy have been used or studied for many different applications, one of which is accelerating wound healing.  ES for the treatment of wounds is the application of electrical current through electrodes place d directly on the skin in close proximity to the wound.  Electromagnetic therapy uses a pulsed magnetic field to induce current.  The Centers for Medicare & Medicaid Services (CMS) was asked to reconsider its national non- coverage determination for electro magnetic therapy.  After thorough review, CMS determined that the results from the use of electromagnetic therapy for the treatment of wounds were similar to the results from the use of ES.  Therefore, effective July 1, 2004, Medicare will cover electromag netic therapy for the same settings and conditions for which ES is covered.  This means Medicare will allow either one covered ES therapy or one covered electromagnetic therapy for the treatment of wounds.  A.  Nationally Covered Indications   The use of ES and electromagnetic therapy for the treatment of wounds are considered adjunctive therapies, and will only be covered for chronic Stage III or Stage IV pressure ulcers, arterial ulcers, diabetic ulcers, and venous stasis ulcers.  Chronic ulce rs are defined as ulcers that have not healed within 30 days of occurrence.  ES or electromagnetic therapy will be covered only after appropriate standard wound therapy has been tried for at least 30 days and there are no measurable signs of improved heali ng.  This 30- day period may begin while the wound is acute.   Standard wound care includes:  optimization of nutritional status, debridement by any means to remove devitalized tissue, maintenance of a clean, moist bed of granulation tissue with appropriate moist dressings, and necessary treatment to resolve any infection that may be present.  Sta ndard wound care based on the specific type of wound includes: frequent repositioning of a patient with pressure ulcers (usually every 2 hours), off -loading of pressure and good glucose control for diabetic ulcers, establishment of adequate circulation for  arterial ulcers, and the use of a compression system for patients with venous ulcers.  Measurable signs of improved healing include: a decrease in wound size (either surface area or volume), decrease in amount of exudates, and decrease in amount of necrotic tissue.  ES or electromagnetic therapy must be discontinued when the wound demonstrat es 100% epithelialized wound bed.   The ES and electromagnetic therapy services can only be covered when performed by a physician, physical therapist, or incident to a physician service.  Evaluation of the wound is an integral part of wound therapy.  When a physician, physical therapist, or a clinician incident to a physician, performs ES or electromagnetic therapy, the practitioner must evaluate the wound and contact the treating physician if the wound worsens.  If ES or electromagnetic therapy is being used, wounds must be evaluated at leas t monthly by the treating physician.   B.  Nationally Non -Covered Indications   1.  ES and electromagnetic therapy will not be covered as an initial treatment modality.   2.  Continued treatment with ES or electromagnetic therapy is not covered if measurable signs of healing have not been demonstrated within any 30- day period of treatment.   3.  Unsupervised use of ES or electromagnetic therapy for wound therapy will not be covered, as this use has not been found to be medically reasonable and necessary.   C.  Other   All other uses of ES and electromagnetic therapy not otherwise specified for the treatment of wounds remain at local Medicare Administrative Contractor discretion.   270.2 - Noncontact Normothermic Wound Therapy (NNWT)  (Rev. 1, 10- 03-03) CIM 60 -25  The NNWT is a device reported to promote wound healing by warming a wound to a predetermined temperature.  The device consists of a noncontact wound cover into which a flexible, battery powered, infrared heating card is inserted.  There is insufficient sci entific or clinical evidence to consider this device as reasonable and necessary for the treatment of wounds within the meaning of 1862(a)(1)(A) of the Act and will not be covered by Medicare.   270.3 - Blood -Derived Products for Chronic Non -Healing Wounds  (Rev. 11214, Issued: 01- 20-22, Effective:04 -13-21, Implementation: 01- 03-22 Shared Systems Contractors, 02- 14-22 MACs)   A. General   Wound healing is a dynamic, interactive process that involves multiple cells and proteins.  There are three progressive stages of normal wound healing, and the typical wound healing duration is about 4 weeks.  While cutaneous wounds are a disruption of the  normal, anatomic structure and function of the skin, subcutaneous wounds involve tissue below the skin's surface.  Wounds are categorized as either acute, where the normal wound healing stages are not yet completed but it is presumed they will be, resulting in orderly and timely wound repair, or chronic, where a wound has failed to progress through the normal wound healing stages and repair itself within a sufficient time period.   Platelet -rich plasma (PRP) is produced in an autologous or homologous manner.  Autologous PRP is comprised of blood from the patient who will ultimately receive the PRP.  Alternatively, homologous PRP is derived from blood from multiple donors.  Blood is donated by the patient and centrifuged to produce an autologous gel for treatment of chronic, non- healing cutaneous wounds that persist for 30 days or longer and fail to properly complete the healing process.  Autologous blood derived products for  chronic, non- healing wounds includes both: (1) platelet derived growth factor (PDGF) products, and (2) PRP (such as AutoloGel).   The PRP is different from previous products in that it contains whole cells including white cells, red cells, plasma, platelets, fibrin, stem cells, and fibrocyte precursors.   The PRP is used by physicians in clinical settings in treating chronic, non- healing wounds, open, cutaneous wounds, soft tissue and bone.  Alternatively, PDGF does not contain cells and was previously marketed as a product to be used by patients at home.  B. Nationally Covered Indications   Effective for services performed on or after April 13, 2021, the Centers for Medicare & Medicaid Services (CMS) will cover autologous PRP for the treatment of chronic non- healing diabetic wounds under section 1862(a)(1)(A) of the Social Security Act (the A ct) for a duration of 20 weeks, when prepared by devices whose Food and Drug Administration- cleared indications include the management of exuding cutaneous wounds, such as diabetic ulcers.    C. Nationally Non -Covered Indications   Autologous PDGF for the treatment of chronic, non- healing cutaneous wounds, and,  Becaplermin, a non -autologous growth factor for chronic, non- healing subcutaneous wounds, and,  Autologous PRP for the treatment of acute surgical wounds when the autologous PRP is applied directly to the closed incision, or for dehiscent wounds.  D. Other   Effective for services performed on or after April 13, 2021: