(Medicare Benefit Policy Manual)

Splints and casts, and other devices used for reductions of fractures and dislocations are covered under Part B of Medicare.  This includes dental splints.  110 - Durable Medical Equipment - General  (Rev. 1, 10-01-03) B3-2100, A3-3113, HO-235, HHA-220  Expenses incurred by a beneficiary for the rental or purchases of durable medical equipment (DME) are reimbursable if the following three requirements are met:    The equipment meets the definition of DME (110.1 );   The equipment is necessary and reasonable for the treatment of the patients illness or injury or to improve the functioning of his or her malformed body member (110.1); and   The equipment is used in the patients home.  The decision whether to rent or purchase an item of equipment generally resides with the beneficiary, but the decision on how to pay rests with CMS.  For some DME, program payment policy calls for lump sum payments and in others for periodic payment.  Wher e covered DME is furnished to a beneficiary by a supplier of services other than a provider of services, the DME MAC makes the reimbursement.  If a provider of services furnishes the equipment, the A/B MAC (A) or (HHH) makes the reimbursement.  The payment method is identified in the annual fee schedule update furnished by CMS.  The CMS issues quarterly updates to a fee schedule file that contains rates by HCPCS code and also identifies the classification of the HCPCS code within the following categories.   Category Code  Definition  IN Inexpensive and Other Routinely Purchased Items FS Frequently Serviced Items  CR Capped Rental Items  OX Oxygen and Oxygen Equipment OS Ostomy, Tracheostomy & Urological Items SD Surgical Dressings PO Prosthetics & Orthotics  SU Supplies TE Transcutaneous Electrical Nerve Stimulators   The A/B MACs (A), (B), and (HHH), and DME MACs, where appropriate, use the CMS files to determine payment rules.  See the Medicare Claims Processing Manual, Chapter 20, Durable Medical Equipment, Surgical Dressings and Casts, Orthotics and Artificial Limbs, and Prosthetic Devices, for a detailed description of payment rules for each classification.  Payment may also be made for repairs, maintenance, and delivery of equipment and for expendable and nonreusable items essential to the effective use of the equipment subject to the conditions in 110.2.  See the Medicare Benefit Policy Manual, Chapter 11, End Stage Renal Disease, for hemodialysis equipment and supplies.  110.1 - Definition of Durable Medical Equipment  (Rev. 10880, Issued: 08-06-21, Effective: 11-08-21, Implementation: 11-08-21)  Durable medical equipment is equipment which:   Can withstand repeated use;    Is primarily and customarily used to serve a medical purpose;    Generally  is not useful to a person in the absence of an illness or injury; and    Is appropriate for use in the home.   All requirements of the definition must be met before an item can be considered to be durable medical equipment.  The following describes the underlying policies for determining whether an item meets the definition of DME and may be covered.  A.  Durability   An item is considered durable if it can withstand repeated use, i.e., the type of item that could normally be rented.  Medical supplies of an expendable nature, such as incontinent pads, lambs wool pads, catheters, ace bandages, elastic stockings, surgical  facemasks, irrigating kits, sheets, and bags are not considered durable within the meaning of the definition.  There are other items that, although durable in nature, may fall into other coverage categories such as supplies, braces, prosthetic devices, artificial arms, legs, and eyes.   B.  Medical Equipment   Medical equipment is equipment primarily and customarily used for medical purposes and is not generally useful in the absence of illness or injury.  In most instances, no development will be needed to determine whether a specific item of equipment is medic al in nature.  However, some cases will require development to determine whether the item constitutes medical equipment.  This development would include the advice of local medical organizations (hospitals, medical schools, medical societies) and specialis ts in the field of physical medicine and rehabilitation.  If the equipment is new on the market, it may be necessary, prior to seeking professional advice, to obtain information from the supplier or manufacturer explaining the design, purpose, effectivenes s and method of using the equipment in the home as well as the results of any tests or clinical studies that have been conducted.   1.  Equipment Presumptively Medical   Items such as hospital beds, wheelchairs, hemodialysis equipment, iron lungs, respirators, intermittent positive pressure breathing machines, medical regulators, oxygen tents, crutches, canes, trapeze bars, walkers, inhalators, nebulizers, commodes, suctio n machines, and traction equipment presumptively constitute medical equipment.  (Although hemodialysis equipment is covered as a prosthetic device (120), it also meets the definition of DME, and reimbursement for the rental or purchase of such equipment f or use in the beneficiarys home will be made only under the provisions for payment applicable to DME.  See the Medicare Benefit Policy Manual, Chapter 11, End Stage Renal Disease, 30.1, for coverage of home use of hemodialysis.)  NOTE:  There is a wide variety in types of respirators and suction machines.  The DME MACs medical staff should determine whether the apparatus specified in the claim is appropriate for home use.  2.  Equipment  Presumptively Nonmedical   Equipment which is primarily and customarily used for a nonmedical purpose may not be considered medical equipment for which payment can be made under the medical insurance program.  This is true even though the item has some remote medically related use .  For example, in the case of a cardiac patient, an air conditioner might possibly be used to lower room temperature to reduce fluid loss in the patient and to restore an environment conducive to maintenance of the proper fluid balance.  Nevertheless, bec ause the primary and customary use of an air conditioner is a nonmedical one, the air conditioner cannot be deemed to be medical equipment for which payment can be made.   Other devices and equipment used for environmental control or to enhance the environmental setting in which the beneficiary is placed are not considered covered DME.  These include, for example, room heaters, humidifiers, dehumidifiers, and electric air cleaners.  Equipment which basically serves comfort or convenience functions or is primarily for the convenience of a person caring for the patient, such as elevators, stairway elevators, and posture chairs, do not constitute medical equipment.  Similarly, physical fitness equipment (such as an exercycle), first -aid or precautionary- type equipment (such as preset portable oxygen units), self -help devices (such as safety grab bars), and training equipment (such as Braille training texts) are considered nonmedi cal in nature.   3.  Special Exception Items   Specified items of equipment may be covered under certain conditions even though they do not meet the definition of DME because they are not primarily and customarily used to serve a medical purpose and/or are generally useful in the absence of illness or injury.  These items would be covered when it is clearly established that they serve a therapeutic purpose in an individual case and would include:   a. Gel pads and pressure and water mattresses (which generally serve a preventive purpose) when prescribed for a patient who had bed sores or there is medical evidence indicating that they are highly susceptible to such ulceration; and  b. Heat lamps for a medical rather than a soothing or cosmetic purpose, e.g., where the need for heat therapy has been established.   In establishing medical necessity for the above items, the evidence must show that the item is included in the physicians course of treatment and a physician is supervising its use.  NOTE:   The above items represent special exceptions and no extension of coverage to other items should be inferred.   C.  Necessary and Reasonable   Although an item may be classified as DME, it may not be covered in every instance.  Coverage in a particular case is subject to the requirement that the equipment be necessary and reasonable for treatment of an illness or injury, or to improve the functioning of a malformed body member.  These considerations will bar payment for equipment which cannot reasonably be expected to perform a therapeutic function in an individual case or will permit only partial therapeutic function in an individual case or will permit only partial payment when the type of equipment furnished substantially exceeds that required for the treatment of the illness or injury involved.  See the Medicare Claims Processing Manual, Chapter 1, General Billing Requirements; 60, regarding the rules for providing advance beneficiary notices (ABNs) that advise beneficiaries, before items or services actually are furnished, when Medicare is lik ely to deny payment for them.  ABNs allow beneficiaries to make an informed consumer decision about receiving items or services for which they may have to pay out -of-pocket and to be more active participants in their own health care treatment decisions.  1.  Necessity for the Equipment   Equipment is necessary when it can be expected to make a meaningful contribution to the treatment of the patients illness or injury or to the improvement of his or her malformed body member.  In most cases the physicians prescription for the equipment and other medical information available to the DME MAC will be sufficient to establish that the equipment serves this purpose.  2.  Reasonableness of the Equipment   Even though an item of DME may serve a useful medical purpose, the DME MAC or A/B MAC (A) must also consider to what extent, if any, it would be reasonable for the Medicare program to pay for the item prescribed.  The following considerations should enter into the determination of reasonableness:   1. Would the expense of the item to the program be clearly disproportionate to the therapeutic benefits which could ordinarily be derived from use of the equipment?   2. Is the item substantially more costly than a medically appropriate and realistically feasible alternative pattern of care?   3. Does the item serve essentially the same purpose as equipment already available to the beneficiary?   3.  Payment Consistent With What is Necessary and Reasonable   Where a claim is filed for equipment containing features of an aesthetic nature or features of a medical nature which are not required by the patients condition or where there exists a reasonably feasible and medically appropriate alternative pattern of c are which is less costly than the equipment furnished, the amount payable is based on the rate for the equipment or alternative treatment which meets the patients medical needs.   The acceptance of an assignment binds the supplier -assignee to accept the payment for the medically required equipment or service as the full charge and the supplier -assignee cannot charge the beneficiary the differential attributable to the equipment actu ally furnished.   4.  Establishing the Period of Medical Necessity   Generally, the period of time an item of durable medical equipment will be considered to be medically necessary is based on the physicians estimate of the time that his or her patient will need the equipment.  See the Medicare Program Integrity Manual, Ch apters 5 and 6, for medical review guidelines.   D.  Definition of a Beneficiarys Home   For purposes of rental and purchase of DME a beneficiarys home may be his/her own dwelling, an apartment, a relatives home, a home for the aged, or some other type of institution (such as an assisted living facility, or an intermediate care facility for individuals with intellectual disabilities (ICF/IID)).  However, an institution may not be consi dered a beneficiarys home if it:    Meets at least the basic requirement (see 1861(e)(1) of the Social Security Act (the Act)) in the definition of a hospital, i.e., it is primarily engaged in providing by or under the supervision of physicians, to inpatients, diagnostic and therapeutic ser vices for medical diagnosis, treatment, and care of injured, disabled, and sick persons, or rehabilitation services for the rehabilitation of injured, disabled, or sick persons; or    Meets at least the basic requirement (see 1819(a)(1) of the Act) in the definition of a skilled nursing facility, i.e., it is primarily engaged in providing to inpatients skilled nursing care and related services for patients who require medical or nursin g care, or rehabilitation services for the rehabilitation of injured, disabled, or sick persons.   Thus, if an individual is a patient in an institution or distinct part of an institution which provides the services described in the bullets above, the individual is not entitled to have separate Part B payment made for rental or purchase of DME.  This is  because such an institution may not be considered the individuals home (see 1861(s)(6) and 1861(n) of the Act, the implementing regulations at 42 CFR 410.38(b), and 2160B in the State Operations Manual (SOM, Pub. 100- 07), Chapter 2).