(Medicare National Coverage Determinations Manual)

High energy pulsed wave diathermy machines have been found to produce some degree of therapeutic benefit for essentially the same conditions and to the same extent as standard diathermy.  Accordingly, where the A/B MACs medical staff has determined that the pulsed wave diathermy apparatus used is one which is considered therapeutically effective, the treatments are considered a covered service, but only for those conditions for which standard diathermy is medically indicated and only when rendered by a physician or incident to a physicians professional services.  Cross -reference: 240.3.  (This NCD last reviewed June 2006.)  150.6 - Vitamin B12 Injections to Strengthen Tendons, Ligaments, etc., of the Foot  (Rev. 1, 10-03-03) CIM 45 -4  Not Covered  Vitamin B12 injections to strengthen tendons, ligaments, etc., of the foot are not covered under Medicare because (1) there is no evidence that vitamin B12 injections are effective for the purpose of strengthening weakened tendons and ligaments, and (2) this is nonsurgical treatment under the subluxation exclusion.  Accordingly, vitamin B12 injections are not considered reasonable and necessary within the meaning of 1862(a)(1) of the Act.   Cross reference:   The Medicare Benefit Policy Manual, Chapter 1, Inpatient Hospital Services, 30.  The Medicare Benefit Policy Manual, Chapter 16, General Exclusions from Coverage, 100.  150.7 - Prolotherapy, Joint Sclerotherapy, and Ligamentous Injections with Sclerosing Agents (Rev. 1, 10-03-03) CIM 35 -13  Not Covered  The medical effectiveness of the above therapies has not been verified by scientifically controlled studies.  Accordingly, reimbursement for these modalities should be denied on the ground that they are not reasonable and necessary as required by 1862(a)(1) of the Act.   150.8 - Fluidized Therapy Dry Heat for Certain Musculoskeletal Disorders  (Rev. 1, 10-03-03) CIM 35 -56  Fluidized therapy is a high intensity heat modality consisting of a dry whirlpool of finely divided solid particles suspended in a heated air stream, the mixture having the properties of a liquid.  Use of fluidized therapy dry heat is covered as an acceptable alternative to other heat therapy modalities in the treatment of acute or subacute traumatic or nontraumatic musculoskeletal disorders of the extremities.   150.9 - Arthroscopic Lavage and Arthroscopic Debridement for the Osteoarthritic Knee (Effective June 11, 2004)  (Rev. 14, 06-10-04)  Arthroscopy is a surgical procedure that allows the direct visualization of the interior joint space.  In addition to providing visualization, arthroscopy enables the process of joint cleansing through the use of lavage or irrigation.  Lavage alone may involve either large or small volume saline irrigation of the knee by arthroscopy.  Although generally performed to reduce pain and improve function, current practice does not recognize the benefit of lavage alone for the reduction of mechanical symptoms.  Arthroscopy also permits the removal of any loose bodies from the interior joint space, a procedure termed debridement.  Debridement, when used alone or not otherwise specified, may include low volume lavage or washout.  Osteoarthritis is a chronic and painful joint disease caused by degeneration.  The American College of Rheumatology defines a patient diagnosis of osteoarthritis of the knee as presenting with pain, and meeting at least 5 of the following criteria:    Over 50 years of age;   Less than 30 minutes of morning stiffness;   Crepitus (noisy, grating sound) on active motion;   Bony tenderness;   Bony enlargement;   No palpable warmth of synovium;   ESR <40mm/hr;   Rheumatoid Factor <1:40; or,  Synovial fluid signs.   A. Nationally Covered Indications   Not applicable.   B. Nationally Noncovered Indications   The clinical effectiveness of arthroscopic lavage and arthroscopic debridement for the severe osteoarthritic knee has not been verified by scientifically controlled studies.  After thorough discussions with clinical investigators, the orthopedic community, and other interested parties, CMS determines that the following procedures are not considered reasonable or necess ary in treatment of the osteoarthritic knee and are not covered by the Medicare program:   Arthroscopic lavage used alone for the osteoarthritic knee;   o Arthroscopic debridement for osteoarthritic patients presenting with knee pain only; or,  o Arthroscopic debridement and lavage with or without debridement for patients presenting with severe osteoarthritis ((Severe osteoarthritis is defined in the Outerbridge classification scale, grades III and IV.  Outerbridge is the most commonly used clinica l scale that classifies the severity of joint degeneration of the knee by compartments and grades.  Grade I is defined as softening or blistering of joint cartilage.  Grade II is defined as fragmentation or fissuring in an area <1 cm.  Grade III presents c linically with cartilage fragmentation or fissuring in an area >1 cm.  Grade IV refers to cartilage erosion down to the bone.  Grades III and IV are characteristic of severe osteoarthritis.)   C. Other  Apart from the noncovered indications above for arthroscopic lavage and/or arthroscopic debridement of the osteoarthritic knee, all other indications of debridement for the subpopulation of patients without severe osteoarthritis of the knee who present wit h symptoms other than pain alone; i.e., (1) mechanical symptoms that include, but are not limited to, locking, snapping, or popping (2) limb and knee joint alignment, and (3) less severe and/or early degenerative arthritis, remain at local A/B MAC discreti on.  Medicare A/B MACs may require submission of one or all of the following documents to define the patients knee condition:   o Operative notes,  o Reports of standing x- rays, or,  o Arthroscopy results.  (This NCD last reviewed June 2004.)   150.10 - Lumbar Artificial Disc Replacement (LADR) (Effective August 14, 2007)  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  A.  General   The lumbar artificial disc replacement (LADR) is a surgical procedure on the lumbar spine that involves complete removal of the damaged or diseased lumbar intervertebral disc and implantation of an artificial disc.  The procedure may be done as an alternative to lumbar spinal fusion and is intended to reduce pain, increase movement at the site of surgery and restore intervertebral disc height.  The Food and Drug Administration has approved the use of LADR for spine arthroplasty in skeletally mature patients with degenerative or discogenic disc disease at on e level for L3 to S1.  B.  Nationally Covered Indications   N/A  C.  Nationally Non -Covered Indications   Effective for services performed from May 16, 2006 through August 13, 2007, the Centers for Medicare and Medicaid Services (CMS) has found that LADR with the ChariteTM lumbar artificial disc is not reasonable and necessary for the Medicare population over 60 years of age; therefore, LADR with the ChariteTM lumbar artificial disc is non -covered for Medicare beneficiaries over 60 years of age.    Effective for services performed on or after August 14, 2007, CMS has found that LADR is not reasonable and necessary for the Medicare population over 60 years of age; therefore, LADR is non- covered for Medicare beneficiaries over 60 years of age.   D.  Other   For Medicare beneficiaries 60 years of age and younger, there is no national coverage determination for LADR, leaving such determinations to continue to be made by the local A/B MACs .  For dates of service May 16, 2006 through August 13, 2007, Medicare coverage under the investigational device exemption (IDE) for LADR with a disc other than the ChariteTM lumbar disc in eligible clinical trials is not impacted.   150.11 - Thermal Intradiscal Procedures (TIPs) (Effective September 29, 2008)  (Rev. 97, Issued: 12- 09-08, Effective: 09 -29-08, Implementation: 01- 05-09)  A. General   Percutaneous thermal intradiscal procedures (TIPs) involve the insertion of a catheter(s)/probe(s) in the spinal disc under fluoroscopic guidance for the purpose of producing or applying heat and/or disruption within the disc to relieve low back pain.   The scope of this national coverage determination on TIPs includes percutaneous intradiscal techniques that employ the use of a radiofrequency energy source or electrothermal energy to apply or create heat and/or disruption within the disc for coagulation and/or decompression of disc material to treat symptomatic patients with annular disruption of a contained herniated disc, to seal annular tears or fissures, or destroy nociceptors for the purpose of relieving pain.  This includes techniques that use singl e or multiple probe(s)/catheter(s), which utilize a resistance coil or other delivery system technology, are flexible or rigid, and are placed within the nucleus, the nuclear -annular junction, or the annulus.  Although not intended to be an all inclusive list, TIPs are commonly identified as intradiscal electrothermal therapy (IDET), intradiscal thermal annuloplasty (IDTA), percutaneous intradiscal radiofrequency thermocoagulation (PIRFT), radiofrequency annuloplasty (RA), intradiscal biacuplasty (IDB), percutaneous (or plasma) disc decompression (PDD) or coblation, or targeted disc decompression (TDD).  At times, TIPs are identified or labeled based on the name of the catheter/probe that is used (e.g., SpineCath, discTRODE, SpineWand, Accutherm, or TransDiscal electrodes).  Each technique or device has it own protocol for application of the therapy.  Percutaneous disc decompression or nucleoplasty procedures that do not utilize a radiofrequency energy source or electrothermal energy (such as the disc decompressor procedure or laser procedure) are not within the scope of thi s NCD.   B. Nationally Covered Indications   N/A  C. Nationally Non -Covered Indications   Effective for services performed on or after September 29, 2008, the Centers for Medicare and Medicaid Services has determined that TIPs are not reasonable and necessary for the treatment of low back pain.  Therefore, TIPs, which include procedures  that employ the use of a radiofrequency energy source or electrothermal energy to apply or create heat and/or disruption within the disc for the treatment of low back pain, are noncovered .  D. Other  N/A  (This NCD last reviewed September 2008.)   150.12  Collagen Meniscus Implant (Effective May 25, 2010)  (Rev. 121, Issued: 05- 28-10, Effective: 05 -25-10, Implementation: 07- 06-10)  A. General   The knee menisci are wedge- shaped, semi -lunar discs of fibrous tissue located in the knee joint between the ends of the femur and the tibia and fibula.  There is a lateral and medial meniscus in each knee.  It is known now that the menisci provide mechanic al support, localized pressure distribution, and lubrication of the knee joint.  Initially, meniscal tears were treated with total meniscectomy; however, as knowledge of the function of the menisci and the potential long term effects of total meniscectomy on the knee joint evolved, treatment of symptomatic meniscal tears gravitated to repair of the tear, when possible, or partial meniscectomy.  The collagen meniscus implant (also referred to as collagen scaffold (CS), CMI or MenaflexTM meniscus implant throughout the published literature) is used to fill meniscal defects that result from partial meniscectomy.  The collagen meniscus implant is not intended to replace the entire meniscus at it requires a meniscal rim for attachment.  The literature describes the placement of the collagen meniscus implant through an arthroscopic procedure with an additional incision for capture of the repair needles and tying of the sutures.  After debridement of the damaged meniscus, the implant is trimmed to the size of meniscal defect and sutured into place.  The collagen meniscus implant is described as a tissue engineered scaffold to support the generation of new  meniscus -like tissue.  The collagen meniscus implant is manufactured from bovine collagen and should not be confused with the meniscus transplant which involves the replacement of the meniscus with a transplant meniscus from a cadaver donor.  The meniscus  transplant is not addressed under this national coverage determination.  B. Nationally Covered Indications   N/A  C. Nationally Non -Covered Indications