evekhm/cms_iom_500 huggingface dataset:
Article - Oral Appliances for Obstructive Sleep Apnea - Policy Article (A52512)
MODIFIERSSuppliers must add a KX modifier to a code only if all of the criteria in the "Coverage Indications, Limitations, and/or Medical Necessity" section of the related LCD have been met. If the requirements for the KX modifier are not met, the KX modifier must not be used.If all of the coverage criteria have not been met, the GA or GZ modifier must be added to a claim line for the oral appliance. When there is an expectation of a medical necessity denial, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN. Claim lines billed without a GA, GZ, or KX modifier will be rejected as missing information.CODING GUIDELINESOral appliances are used to reposition oral and pharyngeal tissues in an effort to create and maintain a beneficiary's airway during sleep.Mandibular advancement devices reposition the mandible in a forward position.Tongue positioning devices reposition the tongue through the use of a vacuum-bulb or other mechanism such as bars, prongs or extensions (not all-inclusive) in a depressed and/or more anterior position.A prefabricated oral appliance (E0485) is one, which is manufactured in quantity without a specific beneficiary in mind. A prefabricated oral appliance may be trimmed, bent, molded (with or without heat), or otherwise modified for use by a specific beneficiary (i.e., custom fitted). Any appliance that does not meet the definition of a custom fabricated oral appliance is considered prefabricated. E0485 is used for all prefabricated oral appliances used for the treatment of OSA including, but not limited to, mandibular advancement devices, tongue positioning appliances, etc.
Article - Oral Appliances for Obstructive Sleep Apnea - Policy Article (A52512)
A custom fabricated oral appliance (E0486) is one that is uniquely made for an individual beneficiary. It involves taking a full arch, negative impression of the beneficiarys teeth, either using appropriate materials or digital images, from which a positive model is created. Basic materials are then cut, bent, and molded using the positive model in order to construct the final oral appliance. A custom fabricated oral appliance may include a prefabricated component (e.g., the joint mechanism).HCPCS code E0486 may only be used for custom fabricated mandibular advancement devices. To be coded as E0486, custom fabricated mandibular advancement devices must meet all of the criteria below:
Article - Oral Appliances for Obstructive Sleep Apnea - Policy Article (A52512)
Have a fixed mechanical hinge (see below) at the sides, front or palate; and,Be able to protrude the individual beneficiary's mandible beyond the front teeth when adjusted to maximum protrusion; and,Incorporate a mechanism that allows the mandible to be easily advanced by the beneficiary in increments of one millimeter or less; and,Retain the adjustment setting when removed from the mouth; and,Maintain the adjusted mouth position during sleep; and,Remain fixed in place during sleep so as to prevent dislodging the device; and,Require no return dental visits beyond the initial 90-day fitting and adjustment period to perform ongoing modification and adjustments in order to maintain effectiveness (see below)A fixed hinge is defined as a mechanical joint, containing an inseparable pivot point. Interlocking flanges, tongue and groove mechanisms, hook and loop or hook and eye clasps, elastic straps or bands, mono-block articulation, traction-based articulation, compression-based articulation, etc. (not all-inclusive) do not meet this requirement.Items that require repeated adjustments and modification beyond the initial 90-day fitting and adjustment period in order to maintain fit and/or effectiveness are not eligible for classification as DME. These items are considered as dental therapies, which are not eligible for reimbursement, by Medicare under the DME benefit. They must not be coded using E0486.
Article - Oral Appliances for Obstructive Sleep Apnea - Policy Article (A52512)
Custom fabricated mandibular advancement devices that do not incorporate all of the criteria above must use HCPCS code A9270 (NON-COVERED ITEM OR SERVICE). Do not use HCPCS code E0486.Tongue positioning appliances are coded A9270.Oral appliances used to treat snoring without a diagnosis of OSA established with a sleep test as described in the LCD are coded A9270 (NON-COVERED ITEM OR SERVICE).Oral occlusal appliances used to treat temporomandibular joint (TMJ) disorders are coded D7880 - occlusal orthotic appliance. Claims for these devices should not be submitted to the DME MACs.HCPCS code E0467 (HOME VENTILATOR, MULTI-FUNCTION RESPIRATORY DEVICE, ALSO PERFORMS ANY OR ALL OF THE ADDITIONAL FUNCTIONS OF OXYGEN CONCENTRATION, DRUG NEBULIZATION, ASPIRATION, AND COUGH STIMULATION, INCLUDES ALL ACCESSORIES, COMPONENTS AND SUPPLIES FOR ALL FUNCTIONS) describes a ventilator that integrates the function of multiple types of equipment into a single device. Code E0467 combines the function of a ventilator with all of the following:Oxygen equipmentNebulizer and compressorAspirator (suction device)Cough stimulator (multiple products)If the multifunction ventilator does not include all of the functions listed above, then the ventilator must not be coded as E0467. Multifunction ventilators that combine some but not all, of the listed functions, must be coded as E1399 (DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS).Positive airway pressure (PAP) devices, respiratory assist devices (RAD), and custom fabricated oral appliances, are considered same or similar to the features of products coded E0467.The following HCPCS code for individual items are included in the functionality of code E0467:HCPCS code E0486For E0467 claims with dates of service before April 3, 2020:
Article - Oral Appliances for Obstructive Sleep Apnea - Policy Article (A52512)
HCPCS code E0486For E0467 claims with dates of service before April 3, 2020:Claims for any of the HCPCS code listed above that are submitted on the same claim or that overlap any date(s) of service for E0467 is considered to be unbundling.In addition, any claim for repair (HCPCS code K0739 for labor and any HCPCS code for replacement items) of beneficiary-owned equipment identified by HCPCS code listed above is considered as unbundling if the date(s) of service for the repair overlaps any date(s) of service for code E0467.Claims for code E0467 with a date(s) of service that overlaps date(s) of service for any of the following scenarios are considered as a claim for same or similar equipment when the beneficiary:Is currently in a rental month for any of the items listed aboveOwns any of the equipment listed above that has not reached the end of its reasonable useful lifetime.
Article - Oral Appliances for Obstructive Sleep Apnea - Policy Article (A52512)
Is currently in a rental month for any of the items listed aboveOwns any of the equipment listed above that has not reached the end of its reasonable useful lifetime.For E0467 claims with dates of service on or after April 3, 2020:Any claim for repair (HCPCS code K0739 for labor and any HCPCS code for replacement items) of beneficiary-owned equipment identified by HCPCS codes listed above is considered as unbundling if the date(s) of service for the repair overlaps any date(s) of service for code E0467.Claims for code E0467 with a date(s) of service that overlaps date(s) of service in a rental month for any of the items listed above are considered as a claim for same or similar equipment.CODING VERIFICATION REVIEWThe only products which may be billed using the following list of HCPCS codes are those for which a written coding verification review (CVR) has been made by the PDAC contractor and subsequently published on the Product Classification List (PCL). Information concerning the documentation that must be submitted to the PDAC for a CVR can be found on the PDAC website or by contacting the PDAC. A PCL with products which have received a coding verification can be found on the PDAC website. The effective date of the CVR is included for each code.Effective for claims with dates of service on or after September 1, 2011:E0486Effective for claims with dates of service on or after January 1, 2022:E0467If a product is billed to Medicare using a HCPCS code that requires written CVR, but the product is not on the PCL for that particular HCPCS code, then the claim line will be denied as incorrect coding.Suppliers should contact the PDAC Contractor for guidance on the correct coding of these items.
Article - Osteogenesis Stimulators - Policy Article (A52513)
CMS National Coverage PolicyN/AArticle Text
Article - Osteogenesis Stimulators - Policy Article (A52513)
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Osteogenesis stimulators are covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.The DME MAC does not process claims for an invasive osteogenesis stimulator.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.
Article - Osteogenesis Stimulators - Policy Article (A52513)
POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.CERTIFICATE OF MEDICAL NECESSITY (CMN)Providers and suppliers no longer need to submit Certificate of Medical Necessity (CMN) for services rendered on or after January 1, 2023.
Article - Osteogenesis Stimulators - Policy Article (A52513)
For claims with dates of service on or after January 1, 2023  Providers and suppliers no longer need to submit CMNs or DIFs with claims. Due to electronic filing requirements, claims received with these forms attached will be rejected and returned to the provider or supplier.For claims with dates of service prior to January 1, 2023  If the CMN or DIF is required, it must be submitted with the claim, or be on file with a previous claim.
Article - Osteogenesis Stimulators - Policy Article (A52513)
For dates of service for which a CMN is required, a CMN, which has been completed, signed, and dated by the treating practitioner, must be kept on file by the supplier and made available upon request. The CMN may act as a substitute for the Standard Written Order (SWO) if it contains the same information as required in a SWO. The CMN for both electrical and ultrasonic osteogenesis stimulators is CMS Form 847. In addition to the order information that the treating practitioner enters in Section B, the supplier can use the space in Section C for a written confirmation of other details of the order or the treating practitioner can enter the other details directly.MODIFIERSGA, GZ, KF and KX MODIFIERSDevices coded E0747, E0748 and E0760 are classified by the Food and Drug Administration as Class III devices; therefore, all claims for codes E0747, E0748 and E0760 must include the KF modifier. Claim lines billed without a KF modifier will be rejected as missing information.Suppliers must add the KX modifier to claim lines billed for osteogenesis stimulators only if all of the coverage criteria in the Coverage Indications, Limitations, and/or Medical Necessity section in the related LCD have been met and evidence of such is retained in the suppliers files and available to the DME MAC upon request.If all of the criteria in the Coverage Indications, Limitations, and/or Medical Necessity section of the related LCD have not been met, the GA or GZ modifier must be added to the code. When there is an expectation of a medical necessity denial, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.Claim lines billed with codes without a KX, GA or GZ modifier will be rejected as missing information.CODING GUIDELINESAn electrical osteogenesis stimulator is a device that provides electrical stimulation to augment bone repair. A noninvasive electrical stimulator is characterized by an external power source which is attached to a coil or electrodes placed on the skin or on a cast or brace over a fracture or fusion site.
Article - Osteogenesis Stimulators - Policy Article (A52513)
An ultrasonic osteogenesis stimulator is a noninvasive device that emits low intensity, pulsed ultrasound. The ultrasound signal is applied to the skin surface at the fracture location via ultrasound conductive coupling gel in order to stimulate fracture healing.Ultrasound conductive coupling gel is billed using code A4559.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.
Article - Oxygen and Oxygen Equipment - Policy Article (A52514)
CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary) and Social Security Act 1834(a)(5)(E).Oxygen and oxygen equipment is covered under the Durable Medical Equipment benefit (Social Security Act 1861(s)(6)). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.REASONABLE USEFUL LIFETIME (RUL):The reasonable useful lifetime for oxygen equipment is 5 years. The RUL is not based on the chronological age of the equipment. It starts on the initial date of service and runs for 5 years from that date.RUL also does not take into account exchanges of equipment, new suppliers, or changes of modality (concentrator, gaseous, liquid).Stationary and portable oxygen equipment is often provided at the same time therefore the RUL for both items runs concurrently. When the RUL of a beneficiarys portable oxygen equipment differs from the RUL of the beneficiarys stationary oxygen equipment, the RUL of the stationary oxygen equipment shall govern the application of RUL-based rules and processes for both types, stationary and portable, of oxygen equipment.Until such time as the end date of the RUL of the stationary oxygen equipment is reached, the supplier must continue to furnish both the portable and stationary oxygen equipment.
Article - Oxygen and Oxygen Equipment - Policy Article (A52514)
If the end date of the RUL of the portable oxygen equipment precedes the end date of the RUL of the stationary oxygen equipment, the end date of the RUL of the portable oxygen equipment is adjusted (extended) to coincide with the end date of the RUL of the stationary oxygen equipment.If the end date of the RUL of the portable oxygen equipment follows the end date of the RUL of the stationary oxygen equipment, the end date of the RUL of the portable oxygen equipment is adjusted (shortened) to coincide with the end date of the RUL of the stationary oxygen equipment.
Article - Oxygen and Oxygen Equipment - Policy Article (A52514)
When the end date of the RUL of the stationary oxygen equipment occurs, the beneficiary may elect to obtain replacement of both the stationary and the portable oxygen equipment.If the beneficiary elects to obtain replacement of the stationary and the portable oxygen equipment, both types of oxygen equipment must be replaced at the same time.When the stationary and the portable oxygen equipment are replaced, a new 36-month rental period and new RUL is started for both the replacement stationary oxygen equipment and the replacement portable oxygen equipment.Beginning January 1, 2011, a beneficiary who resides in a DMEPOS competitive bidding area (CBA) may obtain replacement of both the stationary and portable oxygen systems only from a contract supplier having a competitive bidding contract for the CBA in which the beneficiary permanently resides.A grandfathered supplier for oxygen and other grandfathered equipment as of January 1, 2011, who has continued to furnish such equipment that has not yet reached the 36-month rental cap, does not qualify to furnish replacement equipment once the end date of the RUL of the stationary equipment is reached, if the beneficiary resides in the CBA when the end of the RUL has been reached, unless the status of the grandfathered supplier has changed to a contract supplier for the current round of the competitive bidding program.OXYGEN EQUIPMENT:Initial 36 monthsReimbursement for oxygen equipment is limited to 36 monthly rental payments. Payment for accessories (e.g., cannula, tubing, etc.), delivery, back-up equipment, maintenance, and repairs is included in the rental allowance. Payment for oxygen contents (stationary and/or portable) is included in the allowance for stationary equipment (E0424, E0439, E1390, E1391).Payment for stationary equipment is increased for beneficiaries requiring greater than 4 liters per minute (LPM) of oxygen flow and decreased for beneficiaries requiring less than 1 LPM. If a beneficiary qualifies for additional payment for greater than 4 LPM of oxygen and also meets the requirements for portable oxygen, the appropriate modifiers (QB or QF) must be used.The supplier who provides oxygen equipment for the first month must continue to provide any necessary oxygen equipment and all related items and services through the 36-month rental period, unless one of the following exceptions is met:
Article - Oxygen and Oxygen Equipment - Policy Article (A52514)
Beneficiary relocates temporarily or permanently outside of the suppliers service areaBeneficiary elects to obtain oxygen from a different supplierIndividual case exceptions made by CMS or DME MACItem becomes subject to competitive biddingProviding different oxygen equipment/modalities (e.g., concentrator [stationary or portable], gaseous, liquid, trans-filling equipment) is not permitted unless one of the following requirements is met:Supplier replaces the equipment with the same or equivalent itemTreating practitioners orders different equipmentBeneficiary chooses to receive an upgrade and signs an Advance Beneficiary Notice of Non-coverage (ABN)CMS or the DME MAC determines that a change in equipment is warrantedA new 36-month rental period can begin only in the following situations:Specific incident of damage beyond repair (e.g., dropped and broken, fire, flood, etc.) or the item is stolen or lostBreak-in-need for at least 60 days plus the days remaining in the month of discontinuation and new medical necessity is established (see BREAK-IN-SERVICE below)A new 36-month rental period doesnotstart in the following situations:Replacing equipment due to malfunction, wear and tear, routine maintenance, repairProviding different equipment based on a treating practitioner order or beneficiary request for an upgradeBreak-in-need less than 60 days plus the days remaining in the month of discontinuation (see BREAK-IN-SERVICE below)Break-in-billing (see BREAK-IN-SERVICE below)Changing suppliers
Article - Oxygen and Oxygen Equipment - Policy Article (A52514)
Months 37-60There is no further payment for oxygen equipment during the 5-year reasonable useful lifetime (RUL) of the equipment after 36 rental payments have been made. If use of portable equipment (E0431, E0433, E0434, E1392, K0738) begins after the use of stationary equipment begins, payment for the portable equipment can continue after payment for the stationary equipment ends until 36 rental payments have been made for the portable equipment.For information on payment for contents and maintenance, see separate sections below.The supplier who provided the equipment during the 36th rental month is required to continue to provide the equipment, accessories, contents (if applicable), maintenance, and repair of the oxygen equipment during the 5 year reasonable useful lifetime of the equipment.Rules for providing different equipment/modalities are the same in months 37-60 as they are in the initial 36 months (see above).A new 36-month rental period can begin only in the following situation:There is a specific incident of damage beyond repair (e.g., dropped and broken, fire, flood, etc.) or the item is stolen or lostA new 36-month rental period does not start in the following situations:Replacing equipment due to malfunction, wear and tear, routine maintenance, repairProviding different equipment based on a treating practitioner order or beneficiary request for an upgradeBreak-in-need (see BREAK-IN-SERVICE below)Break-in-billing (see BREAK-IN-SERVICE below)Changing suppliers