(Medicare Claims Processing Manual)

 For patients in an approved clinical trial under the clinical trial policy the - Q1 modifier must be billed for routine costs and not for the device itself   NOTE:  The - Q0/-Q1 modifiers do not need to be applied to these services (92601- 92604, 92507 & 92521-92524).   100.2  Intermediary Payment Requirements (Rev. 601, Issued: 07- 01-05; Effective:  04 -04-05; Implementation: 07 -25-05)  There are no special payment methods.  Existing payment methods shall apply.  100.3  A/B MACs (Part B) Billing Procedures  (Rev. 11875; Issued:02- 23-23; Effective: 09 -26-22; Implementation: 03 -24-23)  Effective for dates of service performed on and after September 26, 2022, the following applies:   A/B MACs (Part B) shall accept claims for cochlear implantation devices and services for beneficiaries meeting the coverage criteria listed under Publication 100- 03, Chapter 1, section 50.3.  A/B MACs (Part B) shall accept claims for cochlear implantation devices and all related costs for beneficiaries not meeting the coverage criteria listed  under Publication 100- 03, Chapter 1, Section 50.3 provided in an FDA -approved category B IDE clinical trial or a trial under the CMS Clinical Trial policy, that is billed with the - Q0 modifier.  The definition of the - Q0 modifier is, Item or service provided in a Medicare specified study.   A/B MACs (Part B)  shall accept claims for routine costs pertaining to beneficiaries not meeting the coverage criteria listed  under Publication 100- 03, Chapter 1, Section 50.3 who are in a clinical trial under the clinical trial policy that is billed with the - Q1 modifier.  The definition of the - Q1 modifier is, Routine clinical service provided in a clinical research study that is in an approved clinical research study   A/B MACs (Part B) shall accept claims for evaluation and therapeutic services related to cochlear implantation.   NOTE:  The - Q0/-Q1 modifier does not need to be applied to these services (92601- 92604, 92507 & 92521-92524).  These services should be billed on an approved electronic claim form or a paper CMS Form 1500.   100.4  Healthcare Common Procedural Coding System (HCPCS)  (Rev. 11875; Issued:02- 23-23; Effective: 09 -26-22; Implementation: 03 -24-23)  The following HCPCS codes are some of those available for use when billing for cochlear implantation services and devices provided by audiologists or physicians, and for the service of 92507, by speech language pathologists.   69930  Cochlear device implantation, with or without mastoidectomy  L8614  Cochlear Device includes all internal and external components   L8619  Cochlear implant external speech processor and controller, integrated system, replacement   L7510  Repair of prosthetic device, repair or replace minor parts   92507  Treatment of speech, language, voice, communication, and/or auditory processing disorder (includes aural rehabilitation); individual  92521  Evaluation of speech fluency (e.g. stuttering, cluttering)   92522  Evaluation of speech sound production (e.g. articulation, phonological process, apraxia, dysarthria)   92523  Evaluation of speech sound production (e.g. articulation, phonological process, apraxia, dysarthria) with evaluation of language comprehension and expression (e.g. receptive and expressive language).   92524  Behavioral and qualitive analysis of voice and resonance   92601  Diagnostic analysis of cochlear implant, patient under 7 years of age; with programming  (Codes 92601 and 92603 describe post -operative analysis and fitting of previously placed external devices, connection to the cochlear implant, and programming of the stimulator.  Codes 92602 and 92604 describe subsequent sessions for measurements and adjus tment of the external transmitter and re -programming of the internal stimulator.)   92602  Diagnostic analysis of cochlear implant, patient under 7 years of age; subsequent programming.  (Do not report 92602 in addition to 92601.)   92603  Diagnostic analysis of cochlear implant, age 7 years or older; with programming  92604  Diagnostic analysis of cochlear implant, age 7 years or older; subsequent reprogramming   A complete list of audiology codes can be found in Pub 100-4, chapter12, section 30.3.  100.5 - Claim Adjustment Reason Codes (CARCs), Remittance Advice Remark Codes (RARCs), Group Codes, and Medicare Summary Notice (MSN) Messages (Rev. 11875; Issued:02-23- 23; Effective: 09 -26-22; Implementation: 03-24-23)  Contractors shall use the appropriate claim adjustment reason codes (CARCs), remittance advice remark codes (RARCs), group codes, or Medicare summary notice (MSN) messages when denying payment for cochlear implantation devices and services for beneficiaries with moderate -to-profound hearing loss in patients with hearing test scores  40% through 9/25/22;  60% effective 9/26/22.   Use the following messages when denying services on claims:   submitted on a TOB other than 11X, 12X (except surgical procedures), 13X or 85X (For Part A only); or  submitted without the Q0/Q1; or   submitted without diagnostic code Z000.6 or  submitted without one of the CPT/HCPCs listed (92521-92524, 92507, 92601- 92604, L7510, L8614, L8619, 69930)  CARC 50 - These are non -covered services because this is not deemed a medical necessity by the payer  RARC N386 - This decision was based on a National Coverage Determination (NCD). An NCD provides a coverage determination as to whether a particular item or service is covered. A copy of this policy is available at www.cms.gov/mcd/search.asp . If you do not have web access, you may contact the contractor to request a copy of the NCD.  MSN 15.20 = The following policies were used when we made this decision:  NCD 50. 3 Spanish translation: Las siguientes polticas fueron utilizadas cuando se tom esta decisin: NCD 50.3)  Contractors processing institutional claims shall use the following MSN message in addition to MSN 15.20:  MSN 15.19 - Local Coverage Determinations (LCDs) help Medicare decide what is covered. An LCD was used for your claim. You can compare your case to the LCD, and send information from your doctor if you think it could change our decision. Call 1-800-MEDICAR E (1-800-633-4227) for a copy of the LCD.  Spanish Version - Las Determinaciones Locales de Cobertura (LCDs en ingls) le ayudan a decidir a Medicare lo que est cubierto. Un LCD se us para su reclamacin. Usted puede comparar su caso con la determinacin y enviar informacin de su mdico si piensa que puede cambiar nuestra decisin. Para obtener una copia del LCD, llame al 1-800- MEDICARE (1 -800-633-4227).  NOTE: Due to system requirement, FISS has combined messages 15.19 and 15.20 so that, when used for the same line item, both messages will appear on the same MSN.    Group Code: CO (Contractual Obligation) assigning financial liability to the provider        A/B MACs (Part A) shall deny for any covered dx audiology/therapy services related to cochlear implantation with the following messages:  Use the following messages when denying services on claims:   Submitted on a TOB other than 11X, 12X (except surgical procedures), 13X or 85X (Part A only), or  submitted without diagnostic code Z00.6  submitted without one of the CPT/HCPCs listed (92521-92524, 92507, 92601- 92604, L7510, L8614, L8619, 69930)  CARC 50 - These are non -covered services because this is not deemed a medical necessity by the payer  RARC N386 - This decision was based on a National Coverage Determination (NCD). An NCD provides a coverage determination as to whether a particular item or service is covered. A copy of this policy is available at www.cms.gov/mcd/search.asp . If you do not have web access, you may contact the contractor to request a copy of the NCD.  MSN 15.20 = The following policies were used when we made this decision: NCD 50. 3   Spanish translation: Las siguientes polticas fueron utilizadas cuando se tom esta decisin: NCD 50.3)  Contractors processing institutional claims shall use the following MSN message in addition to MSN 15.20:  MSN 15.19 - Local Coverage Determinations (LCDs) help Medicare decide what is covered. An LCD was used for your claim. You can compare your case to the LCD, and send information from your doctor if you think it could change our decision. Call 1-800-MEDICAR E (1-800-633-4227) for a copy of the LCD.  Spanish Version - Las Determinaciones Locales de Cobertura (LCDs en ingls) le ayudan a decidir a Medicare lo que est cubierto. Un LCD se us para su reclamacin. Usted puede comparar su caso con la determinacin y enviar informacin de su mdico si piensa que puede cambiar nuestra decisin. Para obtener una copia del LCD, llame al 1-800- MEDICARE (1 -800-633-4227).  NOTE: Due to system requirement, FISS has combined messages 15.19 and 15.20 so that, when used for the same line item, both messages will appear on the same MSN.    Group Code: CO (Contractual Obligation) assigning financial liability to the provider         A/B/MACs (Part B) shall deny claims for evaluation and therapeutic services related to cochlear implantation. NOTE: Modifiers - Q0/-Q1 do not need to be applied to these services (92601 92604, 92521-92524 or any applicable audiology codes).  Use the following messages when denying services on claims:   Submitted without one of the CPT/HCPCs listed (92521-92524, 92507, 92601- 92604).   CARC 50 - These are non -covered services because this is not deemed a medical necessity by the payer  RARC N386 - This decision was based on a National Coverage Determination (NCD). An NCD provides a coverage determination as to whether a particular item or service is covered. A copy of this policy is available at www.cms.gov/mcd/search.asp . If you do not have web access, you may contact the contractor to request a copy of the NCD.  MSN 15.20 - The following policies were used when we made this decision: NCD 50. 3   Spanish translation: Las siguientes polticas fueron utilizadas cuando se tom esta decisin: NCD 50.3)  Group Code - CO (Contractual Obligation) assigning financial liability to the provider        110  Coverage and Billing for Ultrasound Stimulation for Nonunion Fracture Healing  (Rev. 597, Issued: 06-24-05, Effective: 04-27-05, Implementation: 08-01-05)  An ultrasonic osteogenic stimulator is a non- invasive device that emits low intensity, pulsed ultrasound.  This device is applied to the surface of the skin at the fracture site and ultrasound waves are emitted via a conductive coupling gel to stimulate fracture healing.  The ultrasonic osteogenic stimulators are not to be used concurrently with other non- invasive osteogenic devices.   110.1  Coverage Requirements  (Rev. 597, Issued: 06-24-05, Effective: 04-27-05, Implementation: 08-01-05)  Effective for dates of service on and after April 27, 2005, ultrasonic osteogenic stimulators are covered as medically reasonable and necessary for the treatment of nonunion bone fractures prior to surgical intervention.  In demonstrating nonunion fracture s, CMS expects:    A minimum of 2 sets of radiographs, obtained prior to starting treatment with the osteogenic stimulator, separated by a minimum of 90 days.  Each radiograph set must include multiple views of the fracture site accompanied with a written interpretation by a  physician stating that there has been no clinically significant evidence of fracture healing between the 2 sets of radiographs.