evekhm/cms_iom_500 huggingface dataset:
(Medicare National Coverage Determinations Manual)
260.7 - Lymphocyte Immune Globulin, Anti -Thymocyte Globulin (Equine)  (Rev. 1, 10- 03-03) CIM 45 -22  The lymphocyte immune globulin preparations are biologic drugs not previously approved or licensed for use in the management of renal allograft rejection.  A number of other lymphocyte immune globulin products of equine, lapine, and murine origin are curre ntly under investigation for their potential usefulness in controlling allograft rejections in human transplantation.  These biologic drugs are viewed as adjunctive to traditional immunosuppressive products such as steroids and anti -metabolic drugs.  At pr esent, lymphocyte immune globulin preparations are not recommended to replace conventional immunosuppressive drugs, but to supplement them and to be used as alternatives to elevated or accelerated dosing with conventional immunosuppressive agents.   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.
(Medicare National Coverage Determinations Manual)
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
(Medicare National Coverage Determinations Manual)
 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
(Medicare National Coverage Determinations Manual)
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
(Medicare National Coverage Determinations Manual)
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.
(Medicare National Coverage Determinations Manual)
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.
(Medicare National Coverage Determinations Manual)
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:   Coverage of autologous PRP for the treatment of chronic non- healing diabetic wounds beyond 20 weeks will be determined by the local Medicare Administrative Contractors (MACs).  Coverage of autologous PRP for the treatment of all other chronic non -healing wounds will be determined by the local MACs under section 1862(a)(1)(A) of the Act.  (This NCD last reviewed April 2021.)
(Medicare National Coverage Determinations Manual)
(This NCD last reviewed April 2021.)   270.4 - Treatment of Decubitus Ulcers  (Rev. 1, 10- 03-03) CIM 35 -31  An accepted procedure for healing decubitus ulcers is to remove dead tissue from the lesions and to keep them clean to promote the growth of new tissue.  This may be accomplished by hydrotherapy (whirlpool) treatments.  Hydrotherapy (whirlpool) treatment for decubitus ulcers is a covered service under Medicare for patients when treatment is reasonable and necessary. Some other methods of treating decubitus ulcers, the safety and effectiveness of which have not been established, are not covered under the Medicare program.  Some examples of these types of treatments are: ultraviolet light, low intensity direct current, topical application of oxygen, and topica l dressings with Balsam of Peru in castor oil.  270.5 - Porcine Skin and Gradient Pressure Dressings  (Rev. 1, 10- 03-03) CIM 45 -12  Porcine (pig) skin dressings are covered, if reasonable and necessary for the individual patient as an occlusive dressing for burns, donor sites of a homograft, and decubiti and other ulcers.   Gradient pressure dressings are Jobst elasticized heavy duty dressings used to reduce hypertrophic scarring and joint contractures following burn injury.  They are covered when used for that purpose.   270.6 - Infrared Therapy Devices (Effective October 24, 2006)  (Rev. 62, Issued: 12- 15-06, Effective: 10 -24-06, Implementation: 01- 16-07)  A.  General   Infrared therapy devices are used to treat an area of the skin and adjacent subcutaneous tissues of a patient with infrared therapy energy, using an array of juxtaposed infrared diodes affixed to a flexible pad to retain skin contact.  The devices can also  produce local warming, though this may be a secondary effect.  The use of infrared therapy devices has been proposed for a variety of disorders; including treatment of diabetic neuropathy, other peripheral neuropathy, skin ulcers and wounds, and similar r elated conditions, including conditions such as pain arising form these conditions.  A wide variety of devices are currently available.   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 and after October 24, 2006, the Centers for Medicare & Medicaid Services has determined that there is sufficient evidence to conclude the use of infrared therapy devices and any related accessories is not reasonable and necessary under section 1862(a)(1)(A) of the Social Security Act (the Act).  The use of infrared and/or near -infrared light and/or heat, including monochromatic infrared energy, is non- covered for the treatment, including the symptoms such as pain arising form these conditions, of diabetic and/or non-diabetic peripheral sensory neuropathy, wounds and/or ulcers of the skin and/or subcutaneous tissues.   D.  Other   N/A  (This NCD was last reviewed November 2006)   280 - Medical and Surgical Supplies  (Rev. 1, 10- 03-03)  280.1 - Durable Medical Equipment Reference List (Effective May 5, 2005)  (Rev. 12183, Issued:  08-03-23, Effective:  05-16-23, Implementation:09- 04-23)  The durable medical equipment (DME) list that follows is designed to facilitate the A/B MAC  (HHH) and DME MACs processing of DME claims. This section is designed as a quick  reference tool for determining the coverage status of certain pieces of DME and especially for  those items commonly referred to by both brand and generic names. The information contained  herein is applicable (where appropriate) to all DME national coverage determinations (NCDs)  discussed in the DME portion of this manual. The list is organized into two columns. The first  column lists alphabetically various generic categories of equipment on which NCDs have been  made by the Centers for Medicare & Medicaid Services (CMS); the second column notes the  coverage status.
(Medicare National Coverage Determinations Manual)
In the case of equipment categories that have been determined by CMS to be covered under the  DME benefit, the list outlines the conditions of coverage that must be met if payment is to be  allowed for the rental or purchase of the DME by a particular patient, or cross -refers to another  section of the manual where the applicable coverage criteria are described in more detail. With  respect to equipment categories that cannot be covered as DME, the list includes a brief  explanation of why the equipment is not covered. This DME list will be updated periodically to  reflect any additional NCDs that CMS may make with regard to other categories of equipment.   When the A/B MAC (HHH) or DME MAC receives a claim for an item of equipment which  does not appear to fall logically into any of the generic categories listed or has not been addressed in the processes outlined in regulations at 42 CFR 414.114 and 414.240, the A/B MAC (HHH) or DME MAC has the authority and responsibility for deciding whether those items are covered under the DME benefit.   These decisions must be made by each A/B MAC (HHH) and DME MAC based on the advice  of its medical consultants, taking into account:   The Medicare Claims Processing Manual, Chapter 20, Durable Medical Equipment Prosthetics and Orthotics, and Supplies (DMEPOS).   Whether the item has been approved for marketing by the Food and Drug Administration (FDA) and is otherwise generally considered to be safe and effective for the purpose intended; and   Whether the item is reasonable and necessary for the individual patient. The term DME is defined as equipment which, according to 42 CFR 414.202:  Can withstand repeated use; i.e., could normally be rented and used by successive patients;  Effective with respect to items classified as DME after January 1, 2012, has an expected life of at least 3 years;   Is primarily and customarily used to serve a medical purpose;   Generally, is not useful to a person in the absence of illness or injury; and,  Is appropriate for use in a patients home.   Durable Medical Equipment Reference List   Item  Coverage   Air Cleaners  Deny --environmental control equipment; not primarily medical in nature ( 1861(n)  of the Act).
(Medicare National Coverage Determinations Manual)
Durable Medical Equipment Reference List   Item  Coverage   Air Cleaners  Deny --environmental control equipment; not primarily medical in nature ( 1861(n)  of the Act).   Air Conditioners  Deny --environmental control equipment; not primarily medical in nature (1861(n) of the Act).   Air-Fluidized Beds  (See Air -Fluidized Beds 280.8  of this manual.)   Alternating Pressure Pads, Mattresses and Lambs Wool Pads  Covered if patient has, or is highly susceptible to, decubitus ulcers and patients physician specifies that he/she will be supervising the course of treatment.   Audible/Visible Signal/ Pacemaker Monitors  (See Self -Contained Pacemaker Monitor s.)   Augmentative Communication Devices   (See Speech -Generating Devices 50.1  of this manual.)  Bathtub Lifts  Deny --convenience item; not primarily medical in nature (1861(n)  of the Act).   Bathtub Seats  Deny --comfort or convenience item; hygienic equipment; not primarily medical in nature ( 1861(n)  of the Act).  Item  Coverage    Bead Beds  (See 280.8 .)  Bed Baths (home type)  Deny --hygienic equipment; not primarily medical in nature (1861(n)  of the Act).   Bed Lifters (bed elevators)  Deny --not primarily medical in nature ( 1861(n)  of the Act).   Bedboards  Deny --not primarily medical in nature ( 1861(n)  of the Act).   Bed Pans (autoclavable hospital type)   Covered if patient is bed -confined.  Bed Side Rails  (See Hospital Beds 280.7  of this manual.)   Beds -Lounges (power or manual)  Deny --not a hospital bed; comfort or convenience item; not primarily medical in nature ( 1861(n)  of the Act).   Beds (Oscillating)  Deny --institutional equipment; inappropriate for home use.   Bidet Toilet Seats  (See Toilet Seats.)   Blood Glucose Analyzers (Reflectance Colorimeter)   Deny --unsuitable for home use (see 40.2  of this manual).  Blood Glucose Monitors  Covered if patient meets certain conditions (see 40.2  of this manual).   Braille Teaching Texts  Deny --educational equipment; not primarily medical in nature ( 1861(n)  of the Act).