evekhm/cms_iom_500 huggingface dataset:
(Medicare National Coverage Determinations Manual)
(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.
(Medicare National Coverage Determinations Manual)
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,
(Medicare National Coverage Determinations Manual)
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)
(Medicare National Coverage Determinations Manual)
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.
(Medicare National Coverage Determinations Manual)
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
(Medicare National Coverage Determinations Manual)
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
(Medicare National Coverage Determinations Manual)
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
(Medicare National Coverage Determinations Manual)
N/A  C. Nationally Non -Covered Indications   Effective for claims with dates of service performed on or after May 25, 2010, the Centers for Medicare & Medicaid Services has determined that the evidence is adequate to conclude that the collagen meniscus implant does not improve health outcomes and, th erefore, is not reasonable and necessary for the treatment of meniscal injury/tear under section 1862(a)(1)(A) of the Social Security Act.  Thus, the collagen meniscus implant is non -covered by Medicare.   D. Other  N/A  (This NCD last reviewed May 2010.)         150.13  Percutaneous Image -guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS) (Various Effective Dates Below)  (Rev. 200, Issued: 07 -25-17, Effective: 12 -07-16, Implementation: 06- 27-17)   A. General   PILD is a posterior decompression of the lumbar spine performed under indirect image guidance without any direct visualization of the surgical area. This is a procedure proposed as a treatment for symptomatic LSS unresponsive to conservative therapy. This procedure is generally described as a non-invasive procedure using specially designed instruments to percutaneously remove a portion of the lamina and debulk the ligamentum flavum. The procedure is performed under x- ray guidance (e.g., fluoroscopic, CT) wi th the assistance of contrast media to identify and monitor the compressed area via epiduragram.  B. Nationally Covered  Indications   Effective for dates of service specified below, the Centers for Medicare & Medicaid Services (CMS) has determined that PILD will be covered by Medicare when provided in a clinical study under section 1862(a)(1)(E) of the Social Security Act (the Act) throu gh Coverage with Evidence Development (CED) for beneficiaries with LSS who are enrolled in an approved clinical study that meets the criteria in section I or II  below:
(Medicare National Coverage Determinations Manual)
I.    Effective for services performed on or after January 9, 2014, PILD will be covered by Medicare through CED for beneficiaries with LSS who are enrolled in an approved clinical study that meets the following criteria. CMS has a particular interest in improved beneficiary function and quality of life, specific characteristics that identify patients who may benefit from the procedure, and the duration of benefit. A clinical study seeking Medicare payment for PILD for LSS must address one or more aspects o f the following questions in a prospective, randomized, controlled design using current validated and reliable measurement instruments and clinically appropriate comparator treatments, including appropriate medical or surgical interventions or a sham contr olled arm, for patients randomized to the non- PILD  group.   The study protocol must specify a statistical analysis and a minimum length of patient follow up time that evaluates the effect of beneficiary characteristics on patient health outcomes as well as the duration of benefit.  i. Does PILD provide a clinically meaningful improvement of function and/or quality of life in Medicare beneficiaries with LSS compared to other  treatments?   ii. Does PILD provide clinically meaningful reduction in pain in Medicare beneficiaries with LSS compared to other treatments?   iii. Does PILD affect the overall clinical management of LSS and decision making, including use of other medical treatments or services, compared to other  treatments?   These studies must be designed so that the contribution of treatments in addition to the procedure under study are either controlled for or analyzed in such a way as to determine their impact.
(Medicare National Coverage Determinations Manual)
a. The principal purpose of the research study is to test whether a particular intervention potentially improves the participants health outcomes. b. The research study is well supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical  use. c. The research study does not unjustifiably duplicate existing studies. d. The research study design is appropriate to answer the research question being asked in the  study.  e. The research study is sponsored by an organization or individual capable of executing the proposed study successfully. f. The research study is in compliance with all applicable Federal regulations concerning the protection of human subjects found at 45 Code of Federal Regulations (CFR) Part 46. If a study is regulated by the Food and Drug Administration (FDA), it must be in compliance with 21 CFR parts 50 and 56. g. All aspects of the research study are conducted according to appropriate standards of scientific integrity (see  http://www.icmje.org).  h. The research study has a written protocol that clearly addresses, or incorporates by reference, the standards listed here as Medicare requirements for CED  coverage.  i. The clinical research study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. Trials of all medical technologies measuring therapeutic outcomes as one of the objectives meet this standard only if the disease or condition being studied is life threatening as defined in 21 CFR312.81(a) and the patient has no other viable treatment options.  j. The clinical research study is registered on the ClinicalTrials.gov website by the principal sponsor/investigator prior to the enrollment of the first study subject.  k. The research study protocol specifies the method and timing of public release of all prespecified outcomes to be measured including release of outcomes if outcomes are negative or study is terminated early. The results must be made public within 24 months of the end of data collection. If a report is planned to be published in a peer reviewed journal, then that initial release may be an abstract that meets the requirements of the International Committee of Medical Journal Editors  (http://www.icmje.org).  l. The research study protocol must explicitly discuss subpopulations affected by the treatment under investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and exclusion criteria effect enrollment of these populations, and a plan for the retention and reporting of said populations on the
(Medicare National Coverage Determinations Manual)
must explicitly discuss subpopulations affected by the treatment under investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and exclusion criteria effect enrollment of these populations, and a plan for the retention and reporting of said populations on the trial. If the inclusion and exclusion criteria are expected to have a negative effect on the recruitment or retention of underrepresented populations, the protocol must discus s why these criteria are necessary.  m. The research study protocol explicitly discusses how the results are or are not expected to be generalizable to the Medicare population to infer whether Medicare patients may benefit from the intervention. Separate discussions in the protocol may be necess ary for populations eligible for Medicare due to age, disability or Medicaid eligibility.
(Medicare National Coverage Determinations Manual)
Consistent with section 1142 of the Act, the Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies that CMS determines meet the above -listed standards and address the above -listed research questions.  II. Effective for services performed on or after December 7, 2016, CMS will cover through a prospective, longitudinal study PILD procedures using an FDA -approved/cleared device that completed a CMS -approved randomized control trial (RCT) that met the criteria listed in section I  above.   The CMS -approved prospective, longitudinal study must answer at least one of the following questions:   i. Does PILD provide a clinically meaningful improvement of function (e.g., reduced acute and  post-acute hospitalizations, nursing home care or inpatient rehabilitation services) and/or  quality of life in Medicare beneficiaries with LSS compared to other  treatments?   ii. Does PILD provide a clinically meaningful reduction in pain (e.g., as measured by class, dose,  duration of prescription pain medication use) in Medicare beneficiaries with LSS compared to  other  treatments?iii.Does PILD affect the overall clinical management of LSS and decision making,          including use of other medical treatments or services (e.g., repeat PILD              procedures, other interventions and surgical treatments), compared to other              treatments?   The prospective, longitudinal study must also meet the following criteria:   1. The protocol must specify a statistical analysis and a minimum length of patient follow -up time that evaluates the effect of beneficiary characteristics on patient health outcomes as well as the duration of the benefit.  2. The eligibility requirements, both inclusion and exclusion criteria that were specified in the CMS -approved RCT protocol, must be maintained in the new prospective, longitudinal  study.   3. All study sites and study results must be listed in the ClinicalTrials.gov  database.   All CMS -approved clinical research studies must adhere to the following standards of scientific integrity and relevance to the Medicare population:
(Medicare National Coverage Determinations Manual)
3. All study sites and study results must be listed in the ClinicalTrials.gov  database.   All CMS -approved clinical research studies must adhere to the following standards of scientific integrity and relevance to the Medicare population:   a. The principal purpose of the study is to test whether the item or service meaningfully improves health outcomes of affected beneficiaries who are represented by the enrolled  subjects.  b. The rationale for the study is well supported by available scientific and medical  evidence.  c. The study results are not anticipated to unjustifiably duplicate existing knowledge.  d. The study design is methodologically appropriate and the anticipated number of enrolled subjects is sufficient to answer the research question(s) being asked in the National Coverage Determination.  e. The study is sponsored by an organization or individual capable of completing it  successfully.  f. The research study is in compliance with all applicable Federal regulations concerning the protection of human subjects found in the CFR at 45 CFR Part 46. If a study is regulated by the FDA, it is also in compliance with 21 CFR Parts 50 and 56. In addition, to further enhance the protection of human subjects in studies conducted under CED, the study must provide and obtain meaningful informed consent from patients regarding the risks associated with the study items and/or services, and the use and eventual  disposition of the collected data.  g. All aspects of the study are conducted according to appropriate standards of scientific  integrity.  h. The study has a written protocol that clearly demonstrates adherence to the standards listed here as Medicare requirements.