evekhm/cms_iom_500 huggingface dataset:
(Medicare Benefit Policy Manual)
for a capped rental DME item, medical necessity for the equipment has been established.  In cases where one or more rental payments have been made for an item classified as capped rental DME, and the supplier transfers title to the equipment prior to the end of a 13 month period of continuous use per 42 CFR 414.230 , Medicare payment can be made for reasonable and necessary maintenance and servicing of the beneficiary -owned DME.  Under the regulations at 42 CFR 414.210(e)(1) , reasonable and necessary charges for maintenance and servicing are those made for parts and labor not otherwise covered under a manufacturers or suppliers warranty.  Charges for routine maintenance and servicing would not be covered.  Charges for maintenance and servicing that exceed the purchase price of the equipment (i.e., the capped rental monthly fee multiplied by 10) would not be reasonable and necessary and should be denied.  C.  Replacement   Replacement refers to the provision of an identical or nearly identical item.  Situations involving the provision of a different item because of a change in medical condition are not addressed in this section.  Equipment which the beneficiary owns or is a capped rental item may be replaced in cases of loss or irreparable damage.  Irreparable damage refers to a specific accident or to a natural disaster (e.g., fire, flood).  A physicians order and/or new Certificate of Medical Necessity (CMN), when required, is needed to reaffirm the medical necessity of the item.
(Medicare Benefit Policy Manual)
Irreparable wear refers to deterioration sustained from day -to-day usage over time and a specific event cannot be identified.  Replacement of equipment due to irreparable wear takes into consideration the reasonable useful lifetime of the equipment.  If the item of equipment has been in continuous use by the patient on either a rental or purchase basis for the equipments useful lifetime, the beneficiary may elect to obtain a new piece of equipment.  Replacement may be reimbursed when a new physician order and/or new CMN, when required, is needed to reaffirm the medical necessity of the item.  The reasonable useful lifetime of durable medical equipment is determined through program instructions.  In the absence of program instructions, A/B MACS (B) may determine the reasonable useful lifetime of equipment, but in no case can it be less than 5 years.  Computation of the useful lifetime is based on when the equipment is delivered to the beneficiary, not the age of the equipment.  Replacement due to wear is not covered during the reasonable useful lifetime of the equipment.  During the reasonable us eful lifetime, Medicare does cover repair up to the cost of replacement (but not actual replacement) for medically necessary equipment owned by the beneficiary. (See subsection A.)  Charges for the replacement of oxygen equipment, items that require frequent and substantial servicing or inexpensive or routinely purchased items which are being rented are not covered.  Cases suggesting malicious damage, culpable neglect, or wrongful disposition of equipment should be investigated and denied where the DME MACs determines that it is unreasonable to make program payment under the circumstances.  DME MACs refer such cases to  the program integrity specialist in the RO.   D.  Delivery   Payment for delivery of DME whether rented or purchased is generally included in the fee schedule allowance for the item.  See Pub. 100- 04, Medicare Claims Processing Manual, Chapter 20, Durable Medical Equipment, Prosthetics and Orthotics, and Supplies ( DMEPOS), for the rules that apply to making reimbursement for exceptional cases.   110.3 - Coverage of Supplies and Accessories  (Rev. 1, 10- 01-03) B3-2100.5, A3- 3113.4, HO -235.4, HHA -220.5
(Medicare Benefit Policy Manual)
110.3 - Coverage of Supplies and Accessories  (Rev. 1, 10- 01-03) B3-2100.5, A3- 3113.4, HO -235.4, HHA -220.5  Payment may be made for supplies, e.g., oxygen, that are necessary for the effective use of durable medical equipment.  Such supplies include those drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic bene fit of the durable medical equipment or to assure the proper functioning of the equipment, e.g., tumor chemotherapy agents used with an infusion pump or heparin used with a home dialysis system.  However, the coverage of such drugs or biologicals does not preclude the need for a determination that the drug or biological itself is reasonable and necessary for treatment of the illness or injury or to improve the functioning of a malformed body member.   In the case of prescription drugs, other than oxygen, used in conjunction with durable medical equipment, prosthetic, orthotics, and supplies (DMEPOS) or prosthetic devices, the entity that dispenses the drug must furnish it directly to the patient for whom a prescription is written.  The entity that dispenses the drugs must have a Medicare supplier number, must possess a current license to dispense prescription drugs in the State in which the drug is dispensed, and must bill and receive payment in its own name.  A supplier that is not the entity that dispenses the drugs cannot purchase the drugs used in conjunction with DME for resale to the beneficiary.  Reimbursement may be made for replacement of essential accessories such as hoses, tubes, mouthpieces, e tc., for necessary DME, only if the beneficiary owns or is purchasing the equipment.   110.4 - Miscellaneous Issues Included in the Coverage of Equipment  (Rev. 1, 10- 01-03) B3-2100.6, A3- 3113.5, HO -235.5, HHA -220.6
(Medicare Benefit Policy Manual)
Payment can be made for the purchase of DME even though rental payments may have been made for prior months.  This could occur where, because of a change in his/her condition, the beneficiary feels that it would be to his/her advantage to purchase the equipment rather than to continue to rent it.  A beneficiary may sell or otherwise dispose of equipment for which they have no further use, for example, because of recovery from the illness or injury that gave rise to the need for the equipment. (There is no authority for the program to repossess the e quipment.)  If after such disposal there is again medical need for similar equipment, payment can be made for the rental or purchase of that equipment.  However, where an arrangement is motivated solely by a desire to create artificial expenses to be met by the program and to realize a profit thereby, such expenses would not be covered under the program.  The resolution of questions involving the dispositi on and subsequent acquisition of durable medical equipment must be made on a case- by-case basis.   Cases where it appears that there has been an attempt to create an artificial expense and realize a profit thereby should be developed and when appropriate denied.  After adjudication the DME MAC would refer such cases to the program integrity specialist in the RO.  When payments stop because the beneficiarys condition has changed and the equipment is no longer medically necessary, the beneficiary is responsible for the remaining noncovered charges.  Similarly, when payments stop because the beneficiary dies, the ben eficiarys estate is responsible for the remaining noncovered charges.   Contractors do not get involved in issues relating to ownership or title of property.  110.5 - Incurred Expense Dates for Durable Medical Equipment  (Rev. 1, 10- 01-03) A3-3113.7.B, HO -235.7.B, B3- 3011  The date of service on the claim must be the date that the beneficiary or authorized representative received the DMEPOS item.  If the date of delivery is not specified on the bill, the contractor should assume, in the absence of evidence to the contrary, t hat the date of purchase was the date of delivery.
(Medicare Benefit Policy Manual)
For mail order DMEPOS items, the date of service on the claim must be the shipping date.  The date of service on the claim must be the date that the DMEPOS item(s) was received by the nursing facility if the supplier delivered it or the shipping date if the supplier utilized a delivery/shipping service.   An exception to the preceding statements concerning the date of service on the claim occurs when items are provided in anticipation of discharge from a hospital or nursing facility.  If a DMEPOS item is delivered to a patient in a hospital up to two days prior to discharge to home and it is for the benefit of the patient for purposes of fitting or training of the patient on its use, the supplier should bill the date of service on the claim as the date of discharge to home and should use POS=12.  See the Medicare Program Integrity Manual, Chapter 5, Items and Services Having Special DME Review Considerations, for additional information pertaining to the date of service on the claim.  Also see the Medicare Claims Processing Manual, Chapter 20, Du rable Medical Equipment, Surgical dressings and Casts, Orthotics and Artificial Limbs, and Prosthetic Devices, for additional DME billing and claims processing information.   110.6 - Determining Months for Which Periodic Payments May Be Made for Equipment Used in an Institution  (Rev. 1, 10- 01-03) A3-3113.7.D, HO -235.7.C   If a patient uses equipment subject to the monthly payment rule in an institution, which does not qualify as his or her home, the used months during which the beneficiary was institutionalized are not covered.   110.7 - No Payment for Purchased Equipment Delivered Outside the United States or Before Beneficiarys Coverage Began  (Rev. 1, 10- 01-03) A3-3113.7.C   In the case of equipment subject to the lump sum payment rules, the beneficiary must have been in the United States and must have had Medicare coverage at the time the item was delivered.  Therefore, where an item of durable medical equipment paid for as a  lump sum was delivered to an individual outside the United States or before his or her coverage period began, the entire expense of the item would be excluded from coverage.  Payment cannot be made in such cases even though the individual later uses the i tem inside the United States or after his or her coverage begins.
(Medicare Benefit Policy Manual)
If the individual is outside the U.S. for more than 30 days and then returns to the U.S., the DME MAC determines medical necessity as in an initial case before resuming payments.   110.8  DMEPOS Benefit Category Determinations  (Rev.  12171, Issued:08-03-2023, Effective:09- 04-2023, Implementation: 09-04-2023)  Whether or not an item or service falls under a Medicare benefit category, such as the Medicare Part B benefit category for DME, is a necessary step in determining whether an item may be covered under the Medicare program and, if applicable, what statutory and regulatory payment rules apply to the items and services. If the item is excluded from coverage by the Act or does not fall within the scope of a defined benefit category, the item cannot be covered under Medicare Part B.   Medicare Durable Medical Equipment, Prosthetic Devices, Prosthetics, Orthotics and Supplies (DMEPOS) benefit category determinations established on or after September 26, 2022, in accordance with the procedures at 42 CFR 414.114 and 414.240, are listed below. These procedures consider public consultation furnished at public meetings and in writing in accordance with requirements for new DME items by section 531(b) of the Medicare, Medicaid and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub L. 106-554). This section is a quick reference tool for the benefit categories of items and services evaluated using the procedures described above. The section is organized alphabetically by the categories of items and services and then by the benefit category determi nation with effective date.   Special note: the benefit category and payment rules for items and services that are assigned to an existing HCPCS code(s) are determined by the benefit category and payment rules for that HCPCS code(s). More information on the benefit category final determinations for items and services reviewed using the process described above is available at https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/HCPCSPublicMeetings.  DMEPOS Benefit Category Determinations    Item  Benefit Category Determination   Benefit Category  Effective Date  Addition, Endoskeletal  Knee -Shin System, 4 Bar Linkage or Multiaxial, Fluid Swing and Stance Phase Control
(Medicare Benefit Policy Manual)
DMEPOS Benefit Category Determinations    Item  Benefit Category Determination   Benefit Category  Effective Date  Addition, Endoskeletal  Knee -Shin System, 4 Bar Linkage or Multiaxial, Fluid Swing and Stance Phase Control   Artificial Leg --This item is a microprocessor -controlled knee added to a prosthetic leg that utilizes a 4 -bar geometry with hydraulic control of both stance and swing phases of gait.  10-1-22 Addition to Lower Extremity Prosthesis, Endoskeletal Knee Disarticulation, Above Knee, Hip Disarticulation, Positional Rotation Unit  Artificial Leg --This item is added to a prosthetic leg and provides 360- degree rotation of the prosthetic limb to accommodate specific environmental situations.
(Medicare Benefit Policy Manual)
10-1-22 Powered Pressure Reducing Underlay/pad, Alternating, With Pump  DME --Decubitus care equipment which uses alternating turning pressure pad placed under the mattress rather than on top of the mattress.  10-1-22 Cranial Electrotherapy Stimulation System  DME --These  devices utilize a microcurrent to deliver proprietary low -level electrical signals trans cranially to treat insomnia, depression, anxiety, and pain.  10-1-22 Disposable Collection and Storage Bag for Breast Milk, Any Size  No DMEPOS Benefit Category --There is no DMEPOS benefit category for disposable supplies. Also, electric breast pumps are not classified as DME. Therefore, disposable supplies used with these items would not fall under a DMEPOS benefit category. With regard  to manual breast pumps and related supplies, the Medicare Administrative Contractor processing claims for these items would determine whether or not the pump is DME on a claim by claim basis  10-1-22 Distal Transcutaneous Electrical Nerve Stimulator, Stimulates Peripheral Nerves of the Upper Arm  No DMEPOS Benefit Category --Minimum lifetime requirement of at least three years not met.  10-1-22 Electronic Positional Obstructive Sleep Apnea Treatment  Equipment, With Sensor DME --These items are classified as DME if FDA clearance expressly states it is for the treatment of positional obstructive sleep apnea and is not clinically indicated or marketed for anti -snoring or other non-medical uses and all other requirements for classification as DME in accordance with 414.202 are met .  10-1-22 Enema Tube, With or Without Adapter  No DMEPOS Benefit Category --These items cannot withstand repeated use and are therefore not DME. Rectal catheters or tubes are not prosthetic devices because they do not replace all or part of an internal body organ or all or part of the function of a permanently inoperative or malfunctioning internal body organ.   10-1-22 Electrical stimulator supplies (external) for use with implantable neurostimulator, per month Prosthetic Device These items are accessories for n euromodulation systems indicated for pain management in adults who have severe intractable pain of peripheral nerve origin.  4-1-23
(Medicare Benefit Policy Manual)
Expiratory positive airway pressure intranasal resistance valve No DMEPOS Benefit Category -- These are single-patient, reusable expiratory positive airway pressure (EPAP) devices for the treatment of obstructive sleep apnea. These single- patient items cannot withstand repeated use and therefore are not DME.  4-1-23
(Medicare Benefit Policy Manual)
External Upper Limb Tremor Stimulator of the Peripheral Nerves of the Wrist  DME --These devices deliver electrical stimulation to the nerves in the wrist to stimulate the peripheral nervous system for the treatment of essential tremors.  10-1-22 Foot Adductus Positioning Device, Adjustable Leg Brace --These are foot positioning devices that stabilize the heel in the heel cage and the rest of the foot in the device while applying corrective pressures to the midfoot, thereby realigning the malformed pediatric foot. This is considered to be an alternative to serial casting. The devices treat new borns with semiflexible and rigid metatarsus adductus/varus, as well as flexible metatarsus adductus/varus that does not respond to stretching.  10-1-22 Hydrophilic, Dual Focus Contact Lens  No DMEPOS Benefit Category --Contact lens used for the correction of myopic ametropia and for slowing the progression of myopia in children. These lenses do not qualify as prosthetic devices under any of the categories for prosthetic lenses under section 120.B of chapter 15 of the Medi care Benefit Policy Manual.  10-1-22 Hydrophilic, Spherical Contact Lens with Photochromic Additive  Prosthetic Device --Refractive lenses are covered as prosthetic lenses under the benefit category for prosthetic devices when they are used to restore the vision normally provided by the natural lens of the eye of an individual lacking the organic lens beca use of surgical removal or congenital absence. Covered diagnoses are limited to pseudophakia (condition in which the natural lens has been replaced with an artificial intraocular lens [IOL]), aphakia (condition in which the natural lens has been removed but there is no IOL), and congenital aphakia. Lenses provided for other diagnoses will be denied as noncovered. Coverage may be limited to one pair of eyeglasses or contact lenses. Because coverage of refractive lenses is based upon the prosthetic device ben efit category, there is no coverage for frames or lens add -on codes unless there is a covered lens(es). Tinted lenses, including photochromatic lenses, used as sunglasses, which are prescribed in addition to regular prosthetic lenses to a pseudophakic bene ficiary, will be denied as noncovered.
(Medicare Benefit Policy Manual)
10-1-22 Indwelling intraurethral drainage device with valve, patient inserted  Prosthetic Device The device is a urethral insert with a valve for bladder drainage. The intraurethral device replaces the function of a permanently inoperative bladder.  4-1-23  Knee Ankle Foot Device, Any Material, Single or Double Upright, Swing and Stance Phase Microprocessor Control with Adjustability, Includes All Components (e.g., Sensors, Batteries, Charger), Any Type Activation, with or without Ankle Joint(s), Custom Fabri cated  Leg Brace --Rigid device used for the purpose of supporting a weak or deformed leg.   10-1-22 Low Frequency Ultrasonic Diathermy Treatment Device for Home Use  No DMEPOS Benefit Category --Minimum lifetime requirement of at least three years not met. These items are not the standard pulses wave types of diathermy machines referenced in section 280.1 of chapter 1, part 4 of the National Coverage Determinations Manu al. However, the equipment must be able to be rented and used by multiple patients for a minimum of three years in order to be classified as DME.   10-1-22 Mechanical Allergen Particle Barrier/Inhalation Filter, Cream, Nasal, Topical  No DMEPOS Benefit Category --Minimum lifetime requirement of at least three years not met.   10-1-22 Molecular diagnostic test reader, nonprescription self -No DMEPOS Benefit Category -- In vitro diagnostic medical device for analyzing 4-1-23  administered and self -collected use, fda approved, authorized or cleared  specimens in the home collected with the single -use cartridges.  Neuromuscular electrical stimulator (nmes), disposable, replacement only  No DMEPOS Benefit Category  These single -patient items cannot withstand repeated use and therefore are not DME.    4-1-23
(Medicare Benefit Policy Manual)
Non-Invasive Vagus Nerve Stimulator  DME --These devices stimulate the cervical branch of the vagus nerve when applied to the side of the neck through two stainless steel stimulation surfaces.  10-1-22 Non-Pneumatic Compression Controller  DME --These devices use non-pneumatic compression to treat and manage lymphedema.  10-1-22 Oral Device/Appliance for Neuromuscular Electrical Stimulation of the Tongue Muscle for the Reduction of Snoring and Obstructive Sleep Apnea, Controlled by Phone Application  No DMEPOS Benefit Category --The component that performs the medically necessary function of the device is a smartphone which is useful to an individual in the absence of an illness or injury. 10-1-22 Prescription Digital Therapy  No DMEPOS Benefit Category --Digital therapies or computer software are housed on non-medical devices like smartphones or computers and the equipment and software as a whole are not DME.  10-1-22 Speech Volume Modulation System  DME --These devices are worn behind the ear and play background noise (multi -talker babble) in the patients ear only when the patient speaks. The noise elicits the Lombard Effect, automatically increasing the patients vocal intensity, slowing their speech rate, and/or increasing the clarity of their speech.   10-1-22 Suction Pump, Home Model, Portable or Stationary, Electric, for Use with External Urine Management System
(Medicare Benefit Policy Manual)
DME --Home suction pumps have been classified as DME under the HCPCS since 1984 or earlier. This type of home suction pump is used for urine collection or drainage.  10-1-22 Transcutaneous Electrical Nerve Stimulator for Electrical Stimulation of the Trigeminal Nerve  DME --These devices are used during sleep for the treatment for pediatric attention deficit hyperactivity disorder (ADHD).  10-1-22 Upper extremity medical tubing/lines enclosure or covering device, restricts elbow range of motion  No DMEPOS Benefit Category The device is safety equipment to prevent patient entanglement when stationary or mobile with  vital tubes, lines and catheters. There is not a benefit category under Medicare Part B for safety equipment used in the home.  4-1-23 Virtual reality cognitive behavioral therapy device (cbt), including pre -programmed therapy software  DME -- The device delivers a clinically based multimodal pain self -management program incorporating evidence -based principles of Cognitive Behavioral Therapy (CBT).  4-1-23 Wheelchair Accessory: Dynamic Positioning Hardware for Back  DME --These items are hardware added to the wheelchair to absorb the force of a patients uncontrollable backward jerking motions is classified as DME if necessary for the effective use of a wheelchair classified as DME.  10-1-22 Whirlpool Tub, Walk -In, Portable  No DMEPOS Benefit Category --A portable hydrotherapy unit or whirlpool is useful to individuals in the absence of an illness or injury for relaxation and soothing sore muscles. Per section 280.1 of chapter 1, part 4 of the Medicare National Coverage Determinations Manual, portable whir lpool pumps are not DME because they are not primarily medical in nature and are personal comfort items excluded from Medicare coverage (186 2(a)(6) of the Act).  10-1-22       120 - Prosthetic Devices  (Rev. 1, 10-01-03) B3-2130, A3-3110.4, HO-228.4, A3-3111, HO-229  A.  General
(Medicare Benefit Policy Manual)
120 - Prosthetic Devices  (Rev. 1, 10-01-03) B3-2130, A3-3110.4, HO-228.4, A3-3111, HO-229  A.  General   Prosthetic devices (other than dental) which replace all or part of an internal body organ (including contiguous tissue), or replace all or part of the function of a permanently inoperative or malfunctioning internal body organ are covered when furnished on a physicians order.  This does not require a determination that there is no possibility that the patients condition may improve sometime in the future.  If the medical record, including the judgment of the attending physician, indicates the condition is of long and indefinite duration, the test of permanence is considered met.  (Such a device may also be covered under 60.l as a supply when furnished incident to a physicians service.)