evekhm/cms_iom_500 huggingface dataset:
Article - Wheelchair Seating - Policy Article (A52505)
It has a removable vapor permeable or waterproof cover or it has a waterproof surface; andThe cushion and cover meet the minimum standards of the California Bulletin 117, California Bulletin 133, or equivalent (such as standards established by the ASTM, the EPA, or other national or international standards agencies),for flame resistance; andIt has a permanent label indicating the model and the manufacturer; andIt has a warranty that provides for repair or full replacement if manufacturing defects are identified or the surface does not remain intact due to normal wear within 18 months.Included in this definition are cushions which have a planar surface but have positioning features within the cushion which are made of a firmer material than the surface material.A positioning back cushion may have materials or components that may be added or removed to help address orthopedic deformities or postural asymmetries.A custom fabricated seat cushion (E2609) and a custom fabricated back cushion (E2617) are cushions that are individually made for a specific beneficiary starting with basic materials including:liquid foam or a block of foam andsheets of fabric or liquid coating material.The cushion must be fabricated using one or more of the following techniques to capture the individual shape of the beneficiary:molded-to-beneficiary-model technique;direct molded-to-beneficiary technique;CAD/CAM technology, which:allows for the use of direct digital scanning of the beneficiary or of a mold made directly from the beneficiary;allows for direct milling of either (1) a beneficiary-specific model used to shape the cushion contour or (2) the cushion contours; ordetailed measurements of the beneficiary used to create a configured cushion.The cushion must have structural features that significantly exceed the minimum requirements for a seat or back positioning cushion. The cushion must have a removable vapor permeable or waterproof cover or it must have a waterproof surface. A custom fabricated cushion may include certain prefabricated components (e.g., gel or multi-cellular air inserts); these components must not be billed separately. If a custom fabricated seat and back are integrated into a one-piece cushion, code as E2609 plus E2617.
Article - Wheelchair Seating - Policy Article (A52505)
If foam-in-place or other material is used to fit a substantially prefabricated cushion to an individual beneficiary, the cushion must be billed as a prefabricated cushion, not custom fabricated.A powered wheelchair seat cushion (E2610) is a battery-powered, prefabricated cushion in which an air pump provides either sequential inflation or deflation of the air cells or a low interface pressure throughout the cushion. One type of powered seat cushion is an alternating pressure cushion.Pediatric seating system codes E2291, E2292, E2293, E2294 may only be billed with pediatric wheelchair base codes.A headrest extension (E0966) is a sling support for the head. Code E0955 describes any type of cushioned headrest.A headrest (E0955) describes any type of cushioned headrest which may contain one or more cushions to position the head and fixed mounting hardware.Lateral positioning items are used to provide lateral thigh or knee support (E0953) or lateral trunk or hip support (E0956). These are provided in a variety of shapes and sizes to suit the needs of the user.The code for a seat or back cushion includes any rigid or semi-rigid base or posterior panel, respectively, that is an integral part of the cushion.A solid insert is a separate rigid piece of wood or plastic which is inserted in the cover of a cushion to provide additional support. If a supplier chooses to bill separately for a solid insert used with a seat cushion use code E0992 whether it is a manual or a power wheelchair. Code A9900 must be used for a solid insert used with a back cushion.A solid support base for a seat cushion is a rigid piece of plastic or other material which is attached with hardware to the seat frame of a wheelchair in place of a sling seat. A cushion is placed on top of the support base. Use code E2231 for a solid support base that is used with a manual wheelchair. A solid support base is included in the allowance for the power wheelchair codes. There should be no separate billing with power wheelchairs.If a supplier chooses to bill separately for mounting hardware, either nonadjustable or adjustable, for a seat or back cushion or solid support base, code A9900 must be used.
Article - Wheelchair Seating - Policy Article (A52505)
If a supplier chooses to bill separately for mounting hardware, either nonadjustable or adjustable, for a seat or back cushion or solid support base, code A9900 must be used.The only products which may be billed using codes E2601, E2602, E2603, E2604, E2605, E2606, E2607, E2608, E2610, E2611, E2612, E2613, E2614, E2615, E2616, E2620, E2621, and E2622, E2623, E2624, E2625 and the only brand name products that may be billed using codes E2609 or E2617 are those products for which a written coding verification review (CVR) has been made by the Pricing, Data Analysis, and Coding (PDAC) contractor. Information concerning the documentation that must be submitted to the PDAC for a written CVR can be found on the PDAC web site or by contacting the PDAC. A Product Classification List (PCL) with products which have received a written CVR can be found on the PDAC web site.If the prefabricated seat cushion, prefabricated back cushion, or a brand name custom fabricated seat or back cushion has not received a written CVR from the PDAC or if the PDAC has reviewed and determined that the product does not meet the criteria for the code, then it must be billed with code K0669.If a product is billed to Medicare using one of the HCPCS codes 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.Pediatric size positioning accessories are billed with the codes described in this policy. Codes E1025, E1026, E1027 (lateral thoracic and lateral/anterior supports) are invalid for claim submission.
Article - Wheelchair Seating - Policy Article (A52505)
Pediatric size positioning accessories are billed with the codes described in this policy. Codes E1025, E1026, E1027 (lateral thoracic and lateral/anterior supports) are invalid for claim submission.Code E1028 (swingaway or removable mounting hardware upgrade) may be billed in addition to codes E0953, E0955, E0956, E0957. It must not be billed in addition to code E0960. It must not be used for mounting hardware related to a wheelchair seat cushion or back cushion code.Wheelchair seat and back cushion codes are all-inclusive. Use of HCPCS code K0108 or any other HCPCS code to separately bill for added components such as the foam blocks, gel packs, air cells, or equivalent material is incorrect coding.The right (RT) and left (LT) modifiers must be used when applicable. Effective for claims with dates of service (DOS) on or after 3/1/2019, when the same HCPCS code for bilateral items (left and right) is billed on the same DOS, bill each item on two separate claim lines using the RT and LT modifiers and 1 unit of service (UOS) on each claim line. Do not use the RTLT modifier on the same claim line and billed with 2 UOS. Claims billed without modifiers RT and/or LT, or with RTLT on the same claim line and 2 UOS, will be rejected as incorrect coding.TESTING METHODOLOGYThere are two testing methods that may be used to document wheelchair seat cushion criteria: the simulation method and the human subject method. Simulation tests are used to measure loaded contour depth and bottoming out. Human subject tests are used to measure peak interface pressure.Simulation TestSimulation tests measure loaded contour depth and bottoming out. They use standardized models of the human buttocks known as cushion-loading indenters (CLIs). There are two CLIs that are used for simulation testing, a 25 mm CLI and a 40 mm CLI. Specific design features of acceptable CLIs can be found on the PDAC web site.Test method for determining 25 mm and 40 mm of contour depth:Place the test cushion on a flat, horizontal surface. Cushions with curved bases must be stable during contour measurement testing.
Article - Wheelchair Seating - Policy Article (A52505)
Test method for determining 25 mm and 40 mm of contour depth:Place the test cushion on a flat, horizontal surface. Cushions with curved bases must be stable during contour measurement testing.Align the CLI so that it is centered from the sides of the cushion and so that the ischial tuberosities of the models are 11-15 cm from the rear edge of the cushion. The ischial tuberosity portion of the CLI should be aligned with the analogous portion of the test cushion.Load the CLI to 140 Newtons (31 pounds) & wait 5 minutes.Contact of the lateral buttons with the cushion indicates that the cushion has contoured to 25 or 40 mm depending on the CLI used - i.e., that it has passed the test for that trial.Repeat the test two times waiting 5 minutes between trials.A cushion must pass the respective contour test during all trials to meet the minimum criteria specified in the cushion definition section.Overload test method for measuring bottoming out:Record the height of the CLI from the horizontal surface at the end of the loaded contour depth test described above.Add 47 Newtons (10 pounds) to the CLI and record the height from the horizontal surface after 1 minute.Subtract the height at overload (#2) from the height at standard load (#1).Round the value in #3 to the nearest 5mm.Remove the overload weight and repeat the test twice, waiting 5 minutes between tests and measuring the height in #1 and #2 each time.Determine the median of the three values recorded in #4. This is the "overload deflection".If the overload deflection is greater than or equal to 5mm, then the cushion is determined not to have bottomed out during the test.Simulated use testing:There must be simulation of 12 or 18 months of use of the cushion (depending on the cushion type - see Definitions section). Following simulated use, the measurements for loaded contour depth and overload as described above must be repeated.Test report:There must be a report of the tests which includes:The name and address of the facility performing the tests and the date(s) of the tests; andThe manufacturer and brand name/number of the test cushion; andThe weight of the cushion to the nearest 250 gm; andThe width and length of the cushion; and
Article - Wheelchair Seating - Policy Article (A52505)
The manufacturer and brand name/number of the test cushion; andThe weight of the cushion to the nearest 250 gm; andThe width and length of the cushion; andThe temperature and relative humidity of the room where the tests are conducted; andIdentification of which CLI was used (25 mm or 40mm); andThe results of the three loaded contour depth tests and the overload deflection test prior to simulated used testing; andA description of the method used to simulate cushion use; andA statement specifying the number of months of use that were simulated; andMeasurements as described in #7 obtained after simulated use testing; andA statement attesting that the testing methodology described in this policy was followed; andThe printed name and signature of the person performing or supervising the tests and the signature date.Human Subject TestsThe ability to demonstrate that there is an important reduction in interface pressure in comparison with a standard reference cushion when tested with human subjects is the basis for this approach. Human subject tests must be performed by an entity that has received human subject testing approval from an Institutional Review Board approved by the US Department of Health and Human Services. Ten (10) wheelchair users must be studied, at least five of which must be clinically insensate on the body surface contacting the cushion.Interface pressure measurements are taken with each subject seated on the cushion being tested as well as on a standardized reference cushion (see below). The measurements are obtained with a transducer placed on top of the cushion. Subjects must be seated on the cushion and interface pressure transducer for at least 60 seconds before data is collected. The subject should be positioned in their typical posture as determined by query and independent facility judgment. Three measurements are taken on each subject on each cushion separated by a complete unloading of the cushion for at least 60 seconds.The standard reference cushion must be an uncovered 75 mm ( 5mm) thick high resiliency foam with a rated 25% indentation force deflection (IFD) equal to 45 pounds (density range of 2.6-2.9 pounds/cubic ft and IFD range of 40-49 pounds).There must be a report of the tests which includes:The name and address of the facility performing the tests and the date(s) of the tests; andThe manufacturer and brand name/number of the test cushion; andInformation about the interface pressure measurement device utilized:Manufacturer and brand name
Article - Wheelchair Seating - Policy Article (A52505)
The name and address of the facility performing the tests and the date(s) of the tests; andThe manufacturer and brand name/number of the test cushion; andInformation about the interface pressure measurement device utilized:Manufacturer and brand nameDate of most recent calibrationPercent error of measurement at 50 and 100 mm Hg pressure; andActual 25% IFD and density of the reference cushion (obtained from the foam manufacturer or supplier) and actual thickness of the reference cushion; andInformation on each subject (coding subjects to preserve confidentiality) including:AgeHeightWeightDisabilityButtocks sensation status; andInterface pressure measurements for each subject on the test cushion and on the reference cushion:If the transducer covers the entire seating area, the entire map showing the pressure in each cell must be submitted. The anatomical locations (as determined by palpation) of the right and left ischial tuberosities and the sacrum/coccyx must be identified on each map. (Data can be submitted as a hard copy map or utilizing the device software.) or,If the transducer only covers a portion of the seat surface, measurements must be taken at the following three locations (as determined by palpation): right and left ischial tuberosities and sacrum/coccyx. The report must identify the anatomical location of each set of measurements. The report must list the pressure in each cell at each specified location. The values for the three locations are considered a single test; andThe Peak Pressure Index (PPI) for each subject on the test cushion and on the reference cushion. The PPI is determined as follows:For each test, identify the cell in the sacro-ischial zone with the highest pressure;Determine the greatest sum of pressures in the identified cell and the adjacent cells in a 9-10 square centimeter area. If there are multiple cells with the same "highest pressure", consider all of them in the determination of the "greatest sum". [Note: A 3 cm by 3 cm square or a 3.5 cm diameter circular area are examples of a 9-10 sq cm area. For example, if using an interface pressure sensing array with a cell size of 1 sq cm, 9 cells (a 3 by 3 array) are used and if using a sensing array with a cell size of 2.5 sq cm, 4 cells (a 2 by 2 array) are used.];
Article - Wheelchair Seating - Policy Article (A52505)
For each test, calculate the average of the cells with the greatest sum of pressures;Calculate the average of the results obtained in step (c) for the 3 tests on the test cushion and the 3 tests on the reference cushion. These values are the PPIs for the subject on each cushion; andA statement attesting that the testing methodology described in this policy was followed; andThe printed name and signature of the person performing or supervising the tests and the signature date.To determine if the minimum performance characteristics specified in the Definitions section for a particular type of cushion have been met, calculate the average PPI for the 10 subjects on the test cushion and the average PPI for the 10 subjects on the reference cushion. Divide the average PPI on the test cushion by the average PPI on the reference cushion and multiply the value by 100 to give the percentage comparison of Peak Pressure Indexes. If the comparative pressures are less than the specified values (125% or 85% depending on the cushion), then the minimum performance characteristics with respect to pressure have been met.
Article - External Infusion Pumps - Policy Article (A52507)
CMS National Coverage PolicyN/AArticle Text
Article - External Infusion Pumps - Policy Article (A52507)
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).External infusion pumps 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.Drugs are only covered as a supply to a covered DME infusion pump. Drugs billed alone (without a covered pump being used) will be denied as statutorily noncovered (no benefit).Infusion drugs started in a practitioners office, whether with or without a pump, must be billed to the local carrier and not the DME MAC. In these cases, the drug or biological may potentially be covered under section 1861(s)(2)(A) and (B) of the Act and is billable to the A/B MAC even though the entire administration of the drug or biological did not occur in the practitioners office or the hospital outpatient department. Equipment, such as an external infusion pump used to begin administration of the drug or biological that the patient takes home to complete the infusion, is not separately billable as durable medical equipment for a drug or biological paid under the section 1861(s)(2)(A) and (B) incident to benefit. These claims will be rejected as wrong jurisdiction.Disposable drug delivery systems, including elastomeric infusion pumps (A4305, A4306, A9274) are non-covered devices because they do not meet the Medicare definition of durable medical equipment. Drugs and supplies used with disposable drug delivery systems are also non-covered items.
Article - External Infusion Pumps - Policy Article (A52507)
Catheter insertion devices for use with external insulin infusion pump infusion cannulas are included in the allowance for code A4224 and are not separately payable.The DME MACs do not process claims for implantable infusion pumps (E0782, E0783, E0785, and E0786) or drugs and supplies used in conjunction with an implantable infusion pump. Claims for these items must be submitted to the A/B MAC.Replacement batteries (K0601, K0602, K0603, K0604, K0605) are not separately payable when billed with a rented infusion pump.Medicare only pays for one pump (K0455) for administering epoprostenol and treprostinil; the supplier is responsible for ensuring that there is an appropriate and acceptable contingency plan to address any emergency situations or mechanical failures of the equipment. A second pump provided as a backup will be denied as not separately payable.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.POLICY SPECIFIC DOCUMENTATION REQUIREMENTS
Article - External Infusion Pumps - Policy Article (A52507)
POLICY SPECIFIC DOCUMENTATION REQUIREMENTSCoverage of an external infusion pump for the administration of continuous subcutaneous insulin as outlined in the related LCDs Coverage Indications, Limitations, and/or Medicalsectionunder criteria IV. C. and D. requires a frequency of glucose self-testing an average of at least 4 times per day. A beneficiary using a continuous glucose monitor (CGM) is inherently testing more than the 4 times per day glucose monitoring requirement. Documentation of the use of a CGM device in the beneficiarys medical records would meet the testing requirement in the External Infusion Pump LCD.In 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.DME INFORMATION FORM (DIF)Providers and suppliers no longer need to submit a DME Information Form (DIF) for services rendered on or after January 1, 2023.