evekhm/cms_iom_500 huggingface dataset:
(Medicare Benefit Policy Manual)
90 - X-Ray, Radium, and Radioactive Isotope Therapy  (Rev. 1, 10- 01-03) B3-2075  These services also include materials and services of technicians.   X-ray, radium, and radioactive isotope therapy furnished in a nonprovider facility require direct personal supervision of a physician.  The physician need not be in the same room, but must be in the area and immediately available to provide assistance and direction throughout the time the procedure is being performed.  This level of physician involvement does not represent a physicians service and cannot be billed as a Part B service.  The physician would have to furnish a reasonable and necessary professi onal service as defined in 30 of this chapter, in order for the physicians activity to be covered.  However, effective for radiation therapy services furnished on or after April 1, 1989, radiologists weekly treatment management services are covered.   A separate charge for the services of a physicist is not recognized unless such services are covered under the incident to provision ( 60.1 of this chapter) or the services are included as part of a technical component service billed by a freestanding radiation therapy center.  The incident to provision may also be extended to include all necessary and appropriate services supplied by a radiation physicist assisting a radiologist when the physicist is in the physicians employ and working under his or her direct supervision.  100 - Surgical Dressings, Splints, Casts, and Other Devices Used for Reductions of Fractures and Dislocations  (Rev. 1, 10-01-03) B3-2079, A3-3110.3, HO-228.3,   Surgical dressings are limited to primary and secondary dressings required for the treatment of a wound caused by, or treated by, a surgical procedure that has been performed by a physician or other health care professional to the extent permissible under State law.  In addition, surgical dressings required after debridement of a wound are also covered, irrespective of the type of debridement, as long as the debridement was reasonable and necessary and was performed by a health care professional acting within the scope of his/her legal authority when performing this function.  Surgical dressings are covered for as long as they are medically necessary.
(Medicare Benefit Policy Manual)
Primary dressings are therapeutic or protective coverings applied directly to wounds or lesions either on the skin or caused by an opening to the skin.  Secondary dressing materials that serve a therapeutic or protective function and that are needed to sec ure a primary dressing are also covered.  Items such as adhesive tape, roll gauze, bandages, and disposable compression material are examples of secondary dressings.  Elastic stockings, support hose, foot coverings, leotards, knee supports, surgical leggings, gauntlets, and pressure garments for the arms and hands are examples of items that are not ordinarily covered as surgical dressings.  Some items, such as transparent film, may be used as a primary or secondary dressing.  If a physician, certified nurse midwife, physician assistant, nurse practitioner, or clinical nurse specialist applies surgical dressings as part of a professional service that is billed to Medicare, the surgical dressings are considered incident to the professional services of the health care practitioner.  (See 60.1, 180, 190, 200, and 210 .)  When surgical dressings are not covered incident to the services of a health care practitioner and are obtained by the patient from a supplier (e.g., a drugstore, physician, or other health care practitioner that qualifies as a supplier) on an order from a physician or other health care professional authorized under State law or regulation to make such an order, the surgical dressings are covered separately under Part B.   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.
(Medicare Benefit Policy Manual)
 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.
(Medicare Benefit Policy Manual)
 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
(Medicare Benefit Policy Manual)
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.
(Medicare Benefit Policy Manual)
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
(Medicare Benefit Policy Manual)
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
(Medicare Benefit Policy Manual)
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
(Medicare Benefit Policy Manual)
 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).   As indicated in 2164 of the SOM, Chapter 2, all hospitals and SNFs that are Medicare- certified are automatically considered to meet the basic requirement described in the applicable bullet above by reason of the Medicare certification itself.  Moreover, even an institution (or portion of an institution) that is not certified for Medicare is precluded from being considered a patients home in this context if it meets either of these basic requirements.  See 2166 of the SOM, Chapter 2, for the administrativ e criteria used in determining whether the basic requirement in the SNF definition is met by a nursing home that is not Medicare-certified (including the non-Medicare portion of an institution that also contains a Medicare-certified distinct part SNF).   If the patient is at home for part of a month and, for part of the same month is in an institution that cannot qualify as his or her home, or is outside the U.S., monthly payments may be made for the entire month.  Similarly, if DME is returned to the prov ider before the end of a payment month because the beneficiary died in that month or because the equipment became unnecessary in that month, payment may be made for the entire month.
(Medicare Benefit Policy Manual)
110.2 - Repairs, Maintenance, Replacement, and Delivery  (Rev. 203, Issued: 02-13-15, Effective: 07-01-15, Implementation: 07-06-15)  Under the circumstances specified below, payment may be made for repair, maintenance, and replacement of medically required DME, including equipment which had been in use before the user enrolled in Part B of the program.  However, do not pay for repair, maintenance, or replacement of equipment in the frequent and substantial servicing or oxygen equipment payment categories.  In addition, payments for repair and maintenance may not include payment for parts and labor covered under a manufacturers or suppli ers warranty.   A.  Repairs   To repair means to fix or mend and to put the equipment back in good condition after damage or wear.  Repairs to equipment which a beneficiary owns are covered when necessary to make the equipment serviceable.  However, do not pay for repair of previously denied equipment or equipment in the frequent and substantial servicing or oxygen equipment payment categories.  If the expense for repairs exceeds the estimated expense of purchasing or renting another item of equipment for the remaining period of medical need, no payment can be made for the amount of the excess.  (See subsection C where claims for repairs suggest malicious damage or culpable neglect.)  Since renters of equipment recover from the rental charge the expenses they incur in maintaining in working order the equipment they rent out, separately itemized charges for repair of rented equipment are not covered.  This includes items in the frequent and substantial servicing, oxygen equipment, capped rental, and inexpensive or routinely purchased payment categories which are being rented.  A new Certificate of Medical Necessity (CMN) and/or physicians order is not needed for repairs.  For replacement items, see Subsection C below.
(Medicare Benefit Policy Manual)
B.  Maintenance  Routine periodic servicing, such as testing, cleaning, regulating, and checking of the beneficiarys equipment, is not covered.  The owner is expected to perform such routine maintenance rather than a retailer or some other person who charges the beneficiary.  Normally, purchasers of DME are given operating manuals which describe the type of servicing an owner may perform to properly maintain the equipment.  It is reasonable to expect that beneficiaries will perform this maintenance.  Thus, hiring a third party to do such work is for the convenience of the beneficiary and is not covered.  However, more extensive maintenance which, based on the manufacturers recommendations, is to be performed by authorized technicians, is covered as repairs for medically necessary equipment which a beneficiary owns.  This might include, for example, breaking down sealed components and performing tests which require specialized testing equipment not available to the beneficiary.  Do not pay for maintenance of purchased items that require frequent and substantial servicing or oxygen equipment.  Since renters of equipment recover from the rental charge the expenses they incur in maintaining in working order the equipment they rent out, separately itemized charges for maintenance of rented equipment are generally not covered.  Payment may not be made for maintenance of rented equipment other than the maintenance and servicing fee established for capped rental items.  For  capped rental  items  which  have  reached  the 13-month rental  cap,  contractors  pay claims  for maintenance and servicing  fees after  6 months  have  passed  from  the end of the final  paid  rental  month or  from  the end of the period the  item is  no longer  covered  under  the suppliers  or manufacturers  warranty,  whichever  is later.  See the Medicare Claims Processing Manual, Chapter 20, Durable Medical Equipment, Prosthetics and Orthotics, and Supplies (DMEPOS), for additional instruction and an example.  A new CMN and/or physicians order is not needed for covered maintenance.  In cases where one or more monthly rental payments have been made in accordance with 42 CFR 414.229