Proposed LCD - Osteogenesis Stimulators (DL33796)

CMS National Coverage PolicyCMS Pub. 100-03 (Medicare National Coverage Determination Manual), Chapter 1, Section 150.2Coverage Indications, Limitations, and/or Medical NecessityFor 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.The purpose of a Local Coverage Determination (LCD) is to provide information regarding reasonable and necessary criteria based on Social Security Act  1862(a)(1)(A) provisions.In addition to the reasonable and necessary criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement:The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.Refer to the Supplier Manual for additional information on documentation requirements.Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.For the items addressed in this LCD, the reasonable and necessary criteria, based on Social Security Act  1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.A non-spinal electrical osteogenesis stimulator (E0747) is covered only if any of the following criteria are met:Nonunion of a long bone fracture (see Appendices section) defined as radiographic evidence that fracture healing has ceased for three or more months prior to starting treatment with the osteogenesis stimulator, orFailed fusion of a joint other than in the spine where a minimum of nine months has elapsed since the last surgery, orCongenital pseudarthrosis.Nonunion of a long bone fracture must be documented by a minimum of two sets of radiographs obtained prior to starting treatment with the osteogenesis stimulator, separated by a minimum of 90 days, each including multiple views of the fracture site, and with a written interpretation by a treating practitioner stating that there has been no clinically significant evidence of fracture healing between the two sets of radiographs.A non-spinal electrical osteogenesis stimulator will be denied as not medically necessary if none of the criteria above are met.A spinal electrical osteogenesis stimulator (E0748) is covered only if any of the following criteria are met:Failed spinal fusion where a minimum of nine months has elapsed since the last surgery, orFollowing a multilevel spinal fusion surgery (see Appendices section), orFollowing spinal fusion surgery where there is a history of a previously failed spinal fusion at the same site.A spinal electrical osteogenesis stimulator will be denied as not medically necessary if none of the criteria above are met.An ultrasonic osteogenesis stimulator (E0760) is covered only if all of the following criteria are met:Nonunion of a fracture documented by a minimum of two sets of radiographs obtained prior to starting treatment with the osteogenesis stimulator, separated by a minimum of 90 days. Each radiograph set must include multiple views of the fracture site accompanied by a written interpretation by a treating practitioner stating that there has been no clinically significant evidence of fracture healing between the two sets of radiographs; andThe fracture is not of the skull or vertebrae; andThe fracture is not tumor related.An ultrasonic osteogenesis stimulator will be denied as not medically necessary if any of the criteria above are not met.Use of an ultrasonic osteogenesis stimulator for the treatment of a fresh fracture or delayed union will be denied as not medically necessary.Ultrasound conductive coupling gel is covered and separately payable if an ultrasonic osteogenesis stimulator is covered.An ultrasonic osteogenesis stimulator will be denied as not medically necessary if it is used with other noninvasive osteogenesis stimulators.GENERALA Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not reasonable and necessary.For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) base items that require a Written Order Prior to Delivery (WOPD), the supplier must have received a signed SWO before the DMEPOS item is delivered to a beneficiary. If a supplier delivers a DMEPOS item without first receiving a WOPD, the claim shall be denied as not reasonable and necessary. Refer to the LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.For DMEPOS base items that require a WOPD, and also require separately billed associated options, accessories, and/or supplies, the supplier must have received a WOPD which lists the base item and which may list all the associated options, accessories, and/or supplies that are separately billed prior to the delivery of the items. In this scenario, if the supplier separately bills for associated options, accessories, and/or supplies without first receiving a completed and signed WOPD of the base item prior to delivery, the claim(s) shall be denied as not reasonable and necessary.An item/service is correctly coded when it meets all the coding guidelines listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC articles. Claims that do not meet coding guidelines shall be denied as not reasonable and necessary/incorrectly coded.Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. Proof of delivery documentation must be made available to the Medicare contractor upon request. All services that do not have appropriate proof of delivery from the supplier shall be denied as not reasonable and necessary.REFILL REQUIREMENTSFor DMEPOS items and supplies provided on a recurring basis, billing must be based on prospective, not retrospective use. For DMEPOS products that are supplied as refills to the original order, suppliers must contact the beneficiary prior to dispensing the refill and not automatically ship on a pre-determined basis, even if authorized by the beneficiary. This shall be done to ensure that the refilled item remains reasonable and necessary, existing supplies are approaching exhaustion, and to confirm any changes or modifications to the order. Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date. For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product. This is regardless of which delivery method is utilized.For all DMEPOS items that are provided on a recurring basis, suppliers are required to have contact with the beneficiary or caregiver/designee prior to dispensing a new supply of items. Suppliers must not deliver refills without a refill request from a beneficiary. Items delivered without a valid, documented refill request will be denied as not reasonable and necessary.Suppliers must not dispense a quantity of supplies exceeding a beneficiary's expected utilization. Suppliers must stay attuned to changed or atypical utilization patterns on the part of their clients. Suppliers must verify with the treating practitioners that any changed or atypical utilization is warranted. Regardless of utilization, a supplier must not dispense more than a three (3)-month quantity at a time.General InformationAssociated InformationDOCUMENTATION REQUIREMENTSSection 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider. It is expected that the beneficiary's medical records will reflect the need for the care provided. The beneficiary's medical records include the treating practitioner's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.GENERAL DOCUMENTATION REQUIREMENTSIn order to justify payment for DMEPOS items, suppliers must meet the following requirements:SWOMedical Record Information (including continued need/use if applicable)Correct CodingProof of DeliveryRefer to the LCD-related Standard Documentation Requirements article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information regarding these requirements.Refer to the Supplier Manual for additional information on documentation requirements.Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSItems covered in this LCD have additional policy-specific requirements that must be met prior to Medicare reimbursement.Refer to the LCD-related Policy article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information.MISCELLANEOUSAPPENDICESA multilevel spinal fusion is one which involves 3 or more vertebrae (e.g., L3-L5, L4-S1, etc).A long bone is limited to a clavicle, humerus, radius, ulna, femur, tibia, fibula, metacarpal, or metatarsal.UTILIZATION GUIDELINESRefer to Coverage Indications, Limitations and/or Medical NecessitySources of InformationN/ABibliographyNA