(Medicare National Coverage Determinations Manual)

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.)   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   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.   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).   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).   Canes  Covered if patient meets Mobility Assistive Equipment clinical criteria (see 280.3 of this manual).   Carafes  Deny --convenience item; not primarily medical in nature (1861(n) of the Act).   Catheters  Deny non-reusable disposable supply ( 1861(n)  of the Act).  (See Medicare Claims Processing Manual, Chapter 20, DMEPOS).   Commodes  Covered if patient is confined to bed or room.  NOTE:  The term room -confined means that patients condition is such that leaving the room is medically Item  Coverage   contraindicated.  The accessibility of bathroom facilities generally would not be a factor in this determination. However, confinement of a patient to a home in a case where there are no toilet facilities in the home may be equated to room confinement.  Moreover, payment may also be made if a patients medical condition confines him to a floor of the home and there is no bathroom located on that floor.  Communicators  (See 50.1  of this manual, Speech Generating Devices.)   Continuous Passive Motion  Devices  Continuous passive motion devices are devices covered for patients who have received a total knee replacement.  To qualify for coverage, use of the device must commence within 2 days following surgery.  In addition, coverage is limited to that portion of the 3 -week period following surgery during which the device  is used in the patients home.  There is insufficient evidence to justify coverage for longer periods of time or for other applications.  Continuous Positive Airway Pressure (CPAP) Devices  (See 240.4  of this manual.)  Crutches  Covered if patient meets Mobility Assistive Equipment clinical criteria (see section 280.3 of this manual).   Cushion Lift Power Seats  (See Seat Lifts.)   Dehumidifiers (room or central heating system type)  Deny --environmental control equipment; not primarily medical in nature ( 1861(n)  of the Act.   Diathermy Machines (standard pulses wave types)  Deny --inappropriate for home use (see 150.5  of this manual).   Digital Electronic Pacemaker Monitors   (See Self -Contained Pacemaker Monitors).  Disposable Sheets and Bags  Deny non-reusable disposable supplies ( 1861(n)  of the Act).   Elastic Stockings  Deny non-reusable supply; not rental -type items ( 1861(n)  of the Act.) (See 270.5 of this manual.)   Electric Air Cleaners  Deny --(see Air Cleaners.) ( 1861(n)  of the Act).   Electric Hospital Beds  (See Hospital Beds 280.7  of this manual.)  Item  Coverage    Electrical Stimulation for Wounds  Deny --inappropriate for home use. (See 270.1  of this manual.)