evekhm/cms_iom_500 huggingface dataset:
Article - Transcutaneous Electrical Nerve Stimulators (TENS) - Policy Article (A52520)
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).Transcutaneous electrical nerve stimulation (TENS) 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.During the rental of a TENS unit, supplies for the unit are included in the rental allowance; there is no additional allowance for items such as electrodes, lead wires, and batteries. If a TENS unit (E0720 or E0730) is purchased, the allowance is all-inclusive of items such as lead wires and one month's supply of items such as electrodes, conductive paste or gel (if needed), and batteries.Refer to the COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY section of the LCD for additional information about coverage criteria and associated documentation.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.
Article - Transcutaneous Electrical Nerve Stimulators (TENS) - Policy Article (A52520)
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.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.For all claims for TENS and related supplies there must be information in the medical record demonstrating that the coverage criteria are met.For acute post-operative pain covered under criterion I of the related LCD, there must be information about:
Article - Transcutaneous Electrical Nerve Stimulators (TENS) - Policy Article (A52520)
The date of surgeryThe nature of the surgeryThe location and severity of the painFor chronic pain covered under criterion II of the related LCD, there must be information in the medical record describing:The location of the painThe severity of the painThe duration of time the beneficiary has had the painThe presumed etiology of the painPrior treatment and results of that treatmentReevaluation of the beneficiary at the end of the trial period, must indicateHow often the beneficiary used the TENS unitThe typical duration of use each timeThe results (effectiveness of therapy)Each claim for code E0731 must be accompanied by the brand, name and model number of the conductive garment.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.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 - Transcutaneous Electrical Nerve Stimulators (TENS) - Policy Article (A52520)
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 TENS is CMS Form 848. In addition to the 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.A CMN is not needed for a TENS rental.MODIFIERSGA, GZ AND KX MODIFIERS:Suppliers must add a KX modifier to codes E0720, E0730, and E0731 only if all of the criteria in the COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY section of the related LCD have been met.For the situation where a KX modifier is required, 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 these codes. When there is an expectation of a reasonable and necessary 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 for E0720, E0730, and E0731 without a GA, GZ or KX modifier as specified above will be rejected as missing information.CODING GUIDELINESA transcutaneous electrical nerve stimulator (TENS) (E0720, E0730) is a device that utilizes electrical current delivered through electrodes placed on the surface of the skin to decrease the patient's perception of pain by inhibiting the transmission of afferent pain nerve impulses and/or stimulating the release of endorphins. A TENS unit must be distinguished from other electrical stimulators (e.g., neuromuscular stimulators) which are used to directly stimulate muscles and/or motor nerves.
Article - Transcutaneous Electrical Nerve Stimulators (TENS) - Policy Article (A52520)
A TENS supply allowance (A4595), is an all-inclusive code and includes items such as electrodes (any type), conductive paste or gel (if needed, depending on the type of electrode), tape or other adhesive (if needed, depending on the type of electrode), adhesive remover, skin preparation materials, batteries (9 volt or AA, single use or rechargeable), and a battery charger (if rechargeable batteries are used).Codes A4556 (Electrodes, [e.g., apnea monitor], per pair), A4558 (Conductive paste or gel), and A4630 (Replacement batteries, medically necessary TENS owned by patient) are not valid for claim submission to the DME MAC. A4595 should be used instead.For code A4557, one unit of service is for lead wires going to two electrodes. If all the lead wires of a 4 lead TENS unit needed to be replaced, billing would be for two units of service.There should be no billing and there will be no separate allowance for replacement electrodes (A4556), conductive paste or gel (A4558), replacement batteries (A4630), or a battery charger used with a TENS unit.Other supplies, including but not limited to the following, will not be separately allowed: adapters (snap, banana, alligator, tab, button, clip), belt clips, adhesive remover, additional connecting cable for lead wires, carrying pouches, or covers.Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.
Article - Urological Supplies - Policy Article (A52521)
CMS National Coverage PolicyN/AArticle Text
Article - Urological Supplies - Policy Article (A52521)
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).Urological supplies are covered under the Prosthetic Device benefit (Social Security Act  1861(s)(8)). 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.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 prior to delivery, it will be eligible for coverage.GENERAL
Article - Urological Supplies - Policy Article (A52521)
GENERALUrinary catheters and external urinary collection devices are covered to drain or collect urine for a beneficiary who has permanent urinary incontinence or permanent urinary retention. Permanent urinary retention is defined as retention that is not expected to be medically or surgically corrected in that beneficiary within 3 months.If the catheter or the external urinary collection device meets the coverage criteria then the related supplies that are necessary for their effective use are also covered. Urological supplies that are used for purposes not related to the covered use of catheters or external urinary collection devices (i.e., drainage and/or collection of urine from the bladder) will be denied as non-covered.The beneficiary must have a permanent impairment of urination. This does not require a determination that there is no possibility that the beneficiary's condition may improve sometime in the future. If the medical record, including the judgment of the treating practitioner, indicates the condition is of long and indefinite duration (ordinarily at least 3 months), the test of permanence is considered met. Catheters and related supplies will be denied as non-covered in situations in which it is expected that the condition will be temporary.The use of a urological supply for the treatment of chronic urinary tract infection or other bladder condition in the absence of permanent urinary incontinence or retention is non-covered. Since the beneficiary's urinary system is functioning, the criteria for coverage under the prosthetic benefit provision are not met.When inserting an inFlow device or using urological supplies in a treating practitioners office as part of a professional service that is billed to Medicare, the supplies are considered incident to the professional services of the health care practitioner and are not separately payable. Claims for these devices must not be submitted. Claims for the professional service, which includes the device, must be submitted to the A/B MAC.
Article - Urological Supplies - Policy Article (A52521)
If additional inFlow devices or urological supplies are sent home with the beneficiary, claims for these devices may be billed to the DME MAC only if the beneficiary's condition meets the definition of permanence as defined in the Prosthetic Device benefit. In this situation, use the place of service corresponding to the beneficiary's residence; Place of Service Office (POS) 11 must not be used. If the beneficiary's condition is expected to be temporary, urological supplies may not be billed. In this situation, they are considered as supplies provided incident to a treating practitioner's service and payment is included in the allowance for the treating practitioner services, which are processed by the A/B MAC.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.When the prescribing practitioner is also the supplier, and is permitted to furnish specific items of DMEPOS, a separate order is not required; however, the medical record must still contain all of the required order elements.CONTINUED MEDICAL NEEDFor all DMEPOS items, the initial justification for medical need is established at the time the item(s) is first ordered, therefore, beneficiary medical records demonstrating that the item is reasonable and necessary are created just prior to, or at the time of, the creation of the initial prescription. Once initial medical need is established, unless continued coverage requirements are specified in the LCD, ongoing need for urological supplies is assumed to drain or collect urine for a beneficiary who has permanent urinary incontinence or permanent urinary retention. There is no requirement for further documentation of continued medical need as long as the beneficiary continues to meet the Prosthetic Devices benefit.MODIFIERSAU MODIFIER:
Article - Urological Supplies - Policy Article (A52521)
MODIFIERSAU MODIFIER:When codes A4217, A4450, and A4452 are used with Urological Supplies, they must be billed with the AU modifier. For this policy, codes A4217, A4450, and A4452 are the only three codes for which the AU modifier may be used. Claim lines for codes A4217, A4450 and A4452 billed for urological supplies without an AU modifier will be rejected as missing information.KX, GA, GY and GZ MODIFIERS:Suppliers must add a KX modifier to a code for the inFlow device, a catheter, an external urinary collection device, or a supply used with one of these items only if both 1 and 2 are met.
Article - Urological Supplies - Policy Article (A52521)
The statutory benefit criteria described in the NONMEDICAL NECESSITY COVERAGE AND PAYMENT RULES section above are met, andThe applicable reasonable and necessary (R&N) criteria described in the COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY section of the related LCD are met.
Article - Urological Supplies - Policy Article (A52521)
If all of the criteria in the NONMEDICAL NECESSITY COVERAGE AND PAYMENT RULES section above are not met, a GY modifier must be added to the code.If all of the applicable R&N criteria in the COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY section in the related LCD have not been met, a GA or GZ modifier must be added to the code. When there is an expectation of a medical necessity (R&N) 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 KX, GA, GY or GZ modifier will be rejected as missing information.MISCELLANEOUSAdhesive strips or tape used with male external catheters are included in the allowance for the code and are not separately payable.Catheter insertion trays (A4310, A4311, A4312, A4313, A4314, A4315, A4316, A4353, and A4354) that contain component parts of the urinary collection system, (e.g., drainage bags and tubing) are inclusive sets and payment for additional component parts will be allowed only per the stated criteria in each section of the policy.Irrigation supplies that are used for care of the skin or perineum of incontinent beneficiaries are non-covered.Claims for sterile water/saline (A4217) and tape (A4450 or A4452) that are billed without an AU modifier or another modifier indicating coverage under a different policy will be rejected as missing information.Extension tubing (A4331) will be covered for use with a latex urinary leg bag (A5112). It is included in the allowance for codes A4314, A4315, A4316, A4354, A4357, A4358, and A5105 and should not be separately billed with these codes.Other supplies used in the management of incontinence, including but not limited to the following items, will be denied as non-covered because they are not prosthetic devices nor are they required for the effective use of a prosthetic device:
Article - Urological Supplies - Policy Article (A52521)
Creams, salves, lotions, barriers (liquid, spray, wipes, powder, paste) or other skin care products (A6250)Catheter care kits (A9270)Adhesive remover (A4455, A4456) (Coverage remains for use with ostomy supplies.)Catheter clamp or plug (A9270)Non-Disposable underpads (A4553)Disposable underpads, e.g., Chux (A4554)Diapers, or incontinent garments, disposable or reusable (A4520)Drainage bag holder or stand (A9270)Urinary suspensory without leg bag (A9270)Measuring container (A9270)Urinary drainage tray (A9270)Gauze pads (A6216, A6217, A6218) and other dressings (coverage remains under other benefits, e.g. surgical dressings)Other incontinence products not directly related to the use of a covered urinary catheter or external urinary collection device (A9270)Disposable external urethral clamp or compression device, with pad and/or pouch, (A4360)
Article - Urological Supplies - Policy Article (A52521)
CODING GUIDELINESThe general term "external urinary collection devices" used in this policy includes male external catheters and female pouches or meatal cups. This term does not include diapers or other types of absorptive pads.A meatal cup female external urinary collection device (A4327) is a plastic cup, which is held in place around the female urethra by suction or pressure and is connected to a urinary drainage container such as a bag or bottle.A pouch type female external collection device (A4328) is a plastic pouch which is attached to the periurethral area with adhesive and which can be connected to a urinary drainage container such as a bag or bottle.A urinary catheter-anchoring device described by code A4333 has an adhesive surface, which attaches to the beneficiary's skin and a mechanism for releasing and re-anchoring the catheter multiple times without changing the anchoring device.A urinary catheter-anchoring device described by code A4334 is a strap, which goes around a beneficiary's leg and has a mechanism for releasing and re-anchoring the catheter multiple times without changing the anchoring device.An intermittent urinary catheter with insertion supplies (A4353) is a kit, which includes a catheter and all supplies necessary for a single, sterile insertion (see below). Code A4353 may be used if any of the following 1, 2 or 3 is supplied:A single sterile package containing both an intermittent urinary catheter and all necessary insertion/collection supplies; orA sterile intermittent urinary catheter plus a separately-packaged sterile kit containing all necessary insertion/collection supplies; orA sterile no-touch type of catheter system.
Article - Urological Supplies - Policy Article (A52521)
The insertion kit (A4353) described in #1 and #2 above contains an intermittent urinary catheter (packaged separately from the other components in #2), lubricant, gloves, antiseptic solution, applicators, a drape, and a collection tray/bag in a sterile package intended for single use. The collection tray/bag is a separate item included within the kit; therefore, materials that serve as non-sterile packaging to contain all of the items in the kit do not meet this requirement. Except as noted in #2 above, code A4353 must not be billed if individual insertion kit components are provided as separate items. When providing a sterile kit, all components are included and packaged as a kit. Separate billing of individual components is considered as unbundling.The product described in #3 is a single-catheter system that is functionally equivalent to a complete sterile insertion kit (A4353) containing a catheter and the additional components as described in the previous paragraph. In order to be coded as A4353, a no-touch type of catheter system must be a sterile, all-inclusive, self-contained system capable of accomplishing intermittent catheterization with sterile technique without the use of additional supplies such as gloves, lubricant, collection chamber, etc. Additional individual components must not be separately billed. Separate billing of additional supply items is considered as unbundling.Therapeutic agent for urinary irrigation (A4321) is defined as a solution containing agents in addition to saline or sterile water (for example acetic acid or hydrogen peroxide) which is used for the treatment or prevention of urinary catheter obstruction.Code A5105 should be used when billing for a urinary suspensory with leg bag.A4326 is a male external catheter with an integrated collection chamber that does not require the use of an additional leg bag.Irrigation solutions containing antibiotics and chemotherapeutic agents should be coded A9270. Irrigating solutions, such as acetic acid or hydrogen peroxide, which is used for the treatment or prevention of urinary obstruction, should be coded A4321.Adhesive strips or tape used with code A4349 (MALE EXTERNAL CATHETER, WITH OR WITHOUT ADHESIVE, DISPOSABLE, EACH) should not be billed separately.