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(Medicare Claims Processing Manual)

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Effective January 1, 2014, if the Category B IDE device is provided at no cost, outpatient prospective payment system (OPPS) providers must report a token charge in the covered charge field along with condition code 53 and Value Code FD. For more information on billing no cost items under the OPPS, refer to Chapter 4, 20.6.9 and 61.3.1 of this manual. Practitioner Billing Routine Costs Practitioners shall submit claims for the routine costs of a clinical trial involving a Category B IDE device by billing according to the clinical trial billing instructions found in section 69.6 of this chapter. Category B Device Effective for claims with dates of service on or after January 1, 2014, it is mandatory to report a clinical trial number on claims for items/services provided in clinical trials/studies/registries, or under CED. Providers report the 8-digit number on the following claims locators: 837 professional claim format (do not use CT on the electronic claim) or, CMS -1500 paper form- place in Field 19 (preceded by CT). In addition to the clinical trial number, claims shall include (in either the primary/secondary positions): If ICD -9-CM is applicable, ICD-9 diagnosis code V70.7 If ICD -10-CM is applicable, ICD-10 diagnosis code Z00.6 HCPCS modifier Q0 or Q1 as appropriate Claims submitted without a clinical trial number shall be returned as unprocessable reporting the following messages: CARC 16: Claim/service lacks information which is needed for adjudication. At least one Remark Code must be provided (may be comprised of either NCPDP Reject Reason Code, or Remittance Advice Remark Code that is not an ALERT.) RARC MA50: Missing/incomplete/invalid Investigational Device Exemption number for FDA -approved clinical trial services. RARC MA130: Your claim contains incomplete and/or invalid information, and no appeal rights are afforded because the claim is unprocessable. Please submit a new claim with the complete/correct information. Group Code-Contractual Obligation (CO) Effective for dates of service on or before December 31, 2007, practitioners must bill the Category B IDE device on a line with a QA modifier (FDA IDE) along with the IDE number. However, effective for dates of service on or after January 1, 2008, practitioners will no longer bill a QA modifier to identify a Category B device. Instead, practitioners will bill a Q0 modifier (numeral 0 versus the letter O) (Investigational clinical service provided in a clinical research study that is in an approved clinical research study) along with the IDE number. The following table shows the designated field locations to report the Category B IDE number on institutional and practitioner claims: Data CMS -1450 CMS -1500 837 institutional claim format and 837 professional claim format IDE # Revenue Code Description field Item 23 Segment 2300, REF02(REF01=LX) Contractors will validate the IDE number for the Category B device when modifier Q0 is submitted on the claim along with the IDE number. Claims containing an invalid IDE number will be returned to the provider using the following messages: RARC MA50: Missing/incomplete/invalid Investigational Device Exemption Number for FDA approved clinical trial services. CARC 16: Claim/service lacks information which is needed for adjudication. At least one Remark Code must be provided (may be comprised of either NCPDP Reject Reason Code, or Remittance Advice Remark Code that is not an ALERT. 69 - Qualifying Clinical Trials (Rev. 487, Issued: 03-04-05, Effective and Implementation: N/A) 69.1 General (Rev. 1147, Issued: 01- 05-07, Effective: 11-06-06, Implementation: 02-05-07) The CMS has issued a National Coverage Determination (NCD) which allows Medicare coverage for the routine costs of qualifying clinical trial services as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials. The coverage requirements for routine costs of qualifying clinical trial services are contained in The National Coverage Determinations Manual, Section 310.1. 69.2 - Payment for Qualifying Clinical Trial Services (Rev. 2998, Issued: 07- 25-14, Effective: Upon implementation of ICD-10; 01-01-12 - ASC X12, Implementation: 08-25-2014 - ASC X12; Upon Implementation of ICD -10) For dates of service on or after September 19, 2000, pay for covered services furnished to beneficiaries participating in qualifying clinical trials. Payment is based on the payment methodology applicable for the service that was furnished (e.g., physicia n fee schedule, lab fee schedule, durable medical equipment fee schedule, reasonable charge, etc.). With the exception of managed care enrollees, applicable deductibles and coinsurance rules apply to clinical trial items and services. The Part A and Part B deductibles are assumed to be met for covered clinical trial services billed on a fee service basis for managed care enrollees. NOTE: Effective for claims with dates of service on or after January 1, 2014, it is mandatory to report a clinical trial number on claims for items/services provided in clinical trials/studies/registries, or under CED. This is the number assigned by the National Library of Medicine (NLM) ClinicalTrials.gov Web site when a new study appears in the NLM Clinical Trials data base. This number is listed prominently on each specific studys page and is always preceded by the letters NCT. Contractors verify the validity of a trial/study/registry by consulting CMSs clinical trials/registry web site at: http://www.cms.gov/Medicare/Medicare- General -Information/MedicareApprovedFacilitie/index.html. NOTE: Contractors shall ensure value code D4/amount data from their internal claims processing is mapped/populated to the 837 institutional claim format for a coordination of benefits 837 institutional claim. 69.3 - Medical Records Documentation Requirements (Rev. 487, Issued: 03-04-05, Effective and Implementation: N/A) The billing provider must include in the beneficiary's medical record the following information: trial name, sponsor, and sponsor-assigned protocol number. This information does not need to be submitted with the claim but must be provided if requested for medical review. 69.4 - Local Medical Review Policy (Rev. 487, Issued: 03-04-05, Effective and Implementation: N/A) Do not develop new or revised LMRPs for clinical trial services. Clinical trial services that meet the requirements of the NCD are considered reasonable and necessary. 69.5 - Billing Requirements General (Rev. 2955, Issued: 05- 14-14, Effective, 01-01-14, Implementation, 01- 06-14) Instruct practitioners and institutional providers to enter clinical trial and non -clinical trial services on separate line items when billing both types of services on the same claim. For services that require a Certificate of Medical Necessity (CMN), continue to require CMNs. Items and services provided free-of-charge by research sponsors generally may not be billed to be paid by Medicare, and providers are not required to submi t the charge to Medicare. If it is necessary for a provider to show the items and services that are provided free-of- charge in order to receive payment for the covered routine costs (e.g. administration of a non- covered chemotherapeutic agent), providers are instructed to submit such charges as non- covered at the time of entry, while also assuring that the beneficiary is not held liable. This instruction applies to all hospitals including hospitals located in Maryland under the jurisdiction of the Health Services Cost Review Commission (HSCRC). For OPPS claims, providers must report a token charge for a no cost item in the covered charge field along with the applicable HCPCS modifier (i.e., modifier FB) appended to the procedure code that reports the service provided to furnish the no cost i tem, in instances when claims processing edits require that certain devices be billed with their associated procedures. For more information on billing no cost items under the OPPS, refer to Chapter 4, 20.6.9 and 61.3.1 of this manual. NOTE: Effective for claims with dates of service on or after January 1, 2014, it is mandatory to report a clinical trial number on claims for items/services provided in clinical trials/studies/registries, or under CED. Future updates will be issued in a Recurring Update Notification. 69.6 - Requirements for Billing Routine Costs of Clinical Trials (Rev. 2998, Issued: 07- 25-14, Effective: Upon implementation of ICD-10; 01-01-12 - ASC X12, Implementation: 08-25-2014 - ASC X12; Upon Implementation of ICD -10) Routine Costs Submitted by Practitioners/Suppliers Claims with dates of service on or after January 1, 2008: HCPCS modifier Q1 (numeral 1 instead of the letter i) ; and, If ICD -9-CM is applicable, ICD-9 diagnosis code V70.7 (Examination of participant in clinical trial) reported as the secondary diagnosis (effective September 19, 2000, diagnosis code V70.7 can be reported as either primary or secondary). If ICD -10-CM is applicable, ICD-10 diagnosis code Z00.6 CMS covers costs of healthy volunteers in a qualified clinical trial if it meets the following conditions: The trial is not designed exclusively to test toxicity or disease pathophysiology. The trial must have therapeutic intent. If the trial has therapeutic interventions, it must enroll patients with diagnosed disease rather than healthy volunteers. If the trial is studying diagnostic interventions, it may enroll healthy patients in order to have a proper control group. Effective for claims processed after September 28, 2009, with dates of service on or after January 1, 2008, claims submitted with modifier Q1 shall be returned as unprocessable if ICD-9-CM code V70.7 (if ICD-9 is applicable) or ICD-10-CM code Z00.6 (if ICD-10- CM is applicable) is not submitted on the claim. Contractors shall return the following messages: Claims adjustment Reason Code 16: Claim/service lacks information which is needed for adjudication. As least one Remark Code must be provided (may be comprised of either the Remittance Advice Code or NCPDP Reject Reason Code). Remittance Advice Remark Code M76: Missing/incomplete/invalid diagnosis or condition. Effective for clinical trial claims received after April 1, 2008, (regardless of the date of service) providers can begin to report an 8-digit clinical trial number. The reporting of this number is voluntary through December 31, 2013. Refer to change request (CR) 5790 for more information regarding the 8-digit number. Effective for claims with dates of service on or after January 1, 2014 it is mandatory to report a clinical trial number on claims for items/services provided in clinical trials/studies/registries, or under CED. Providers report the 8-digit number on the following claims locators: 837 professional claim format-Loop 2300 REF02 (REF01=P4) (do not use CT on the electronic claim); or CMS -1500 paper form- place in Field 19 (preceded by CT). In addition to the clinical trial number, claims should include: If ICD -9-CM is applicable, ICD-9 diagnosis code V70.7 If ICD -10-CM is applicable, ICD -10 diagnosis code Z00.6 (in either the primary/secondary positions) HCPCS modifier Q0 or Q1 as appropriate Practitioner claims submitted without a clinical trial number shall be returned as unprocessable using the following messages: CARC 16: Claim/service lacks information which is needed for adjudication. At least one Remark Code must be provided (may be comprised of either NCPDP Reject Reason Code, or Remittance Advice Remark Code that is not an ALERT.) RARC MA50: Missing/incomplete/invalid Investigational Device Exemption number for FDA -approved clinical trial services. RARC MA130: Your claim contains incomplete and/or invalid information, and no appeal rights are afforded because the claim is unprocessable. Please submit a new claim with the complete/correct information. Group Code-Contractual Obligation (CO) Routine Costs Submitted by Institutional Providers All Institutional Clinical Trial Claims

(Medicare Claims Processing Manual)

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clm104c32.pdf

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CMS -1500 paper form- place in Field 19 (preceded by CT). In addition to the clinical trial number, claims should include: If ICD -9-CM is applicable, ICD-9 diagnosis code V70.7 If ICD -10-CM is applicable, ICD -10 diagnosis code Z00.6 (in either the primary/secondary positions) HCPCS modifier Q0 or Q1 as appropriate Practitioner claims submitted without a clinical trial number shall be returned as unprocessable using the following messages: CARC 16: Claim/service lacks information which is needed for adjudication. At least one Remark Code must be provided (may be comprised of either NCPDP Reject Reason Code, or Remittance Advice Remark Code that is not an ALERT.) RARC MA50: Missing/incomplete/invalid Investigational Device Exemption number for FDA -approved clinical trial services. RARC MA130: Your claim contains incomplete and/or invalid information, and no appeal rights are afforded because the claim is unprocessable. Please submit a new claim with the complete/correct information. Group Code-Contractual Obligation (CO) Routine Costs Submitted by Institutional Providers All Institutional Clinical Trial Claims Effective for clinical trial claims received after April 1, 2008, (regardless of the date of service) providers can begin to report an 8-digit clinical trial number. The reporting of this number is voluntary thru December 31, 2013. Refer to CR 5790 for more information regarding the 8-digit number. To bill the 8- digit clinical trial number, institutional providers shall code value code D4 ---where the value code amount equals the 8 -digit clinical trial number. Below are the claim locators in which to bill the 8 -digit number: 837 institutional claim format-Loop 2300 REF02 (REF01=P4) Paper CMS -1450 value code D4 NOTE: Effective for claims with dates of service on or after January 1, 2014, it is mandatory to report a clinical trial number on claims for items/services provided in clinical trials/studies/registries, or under CED. Institutional claims submitted without a clinical trial number shall be return to providers. NOTE: The Q1 modifier is line item specific and must be used to identify items and services that constitute medically necessary routine patient care or treatment of complications arising from a Medicare beneficiarys participation in a Medicare- covered clinical trial. Items and services that are provided solely to satisfy data collection and analysis needs and that are not used in the clinical management of the patient are not covered and may not be billed using the Q1 modifier. Items and services that a re not covered by Medicare by virtue of a statutory exclusion or lack of a benefit category also may not be billed using the Q1 modifier. When billed in conjunction with the V70.7/Z00.6 diagnosis code, t he Q1 modifier will serve as the providers attestation that the service meets the Medicare coverage criteria (i.e., was furnished to a beneficiary who is participating in a Medicare qualifying clinical trial and represents routine patient care, including complications associated with qualifying trial participation). Inpatient Clinical Trial Claims Institutional providers billing clinical trial service(s) must report ICD -9 diagnosis code V70.7 if ICD -9 is applicable or, i f ICD -10-CM is applicable, ICD -10 diagnosis code Z006 in either the primary or secondary position and a condition code 30 regardless of whether all services are related to the clinical trial or not. NOTE: HCPCS codes are not reported on inpatient claims. Therefore, the HCPCS modifier requirements (i.e., Q0/Q1) as outlined in the outpatient clinical trial section immediately below, are not applicable to inpatient clinical trial claims. Outpatient Clinical Trial Claims On all outpatient clinical trial claims, providers need to do the following: Report condition code 30, Report ICD -9 diagnosis code V70.7, if ICD -9-CM is applicable, in the primary or secondary position; Report ICD -10 diagnosis code Z00.6, if ICD-10-CM is applicable, in the primary or secondary position; and Identify all lines that contain an investigational item/service with a HCPCS modifier of: o Q0 for dates of service on or after 1/1/08 Identify all lines that contain a routine service with a HCPCS modifier of: o Q1 for dates of service on or after 1/1/08. For clinical trial billing requirements for patients enrolled in a managed care plan, please refer to Section 69.9 of this chapter. 69.7 - Reserved for Future Use (Rev. 1418, Issued: 01- 18-08, Effective: 01 -01-08, Implementation: 04- 07-08) 69.8 - Handling Erroneous Denials of Qualifying Clinical Trial Services (Rev. 487, Issued: 03- 04-05, Effective and Implementation: N/A) If a service Medicare covers was billed with the appropriate clinical trial coding but was inadvertently denied (e.g., for medical necessity or utilization) and is subsequently brought to your attention, adjust the denied claim. If the denied services wer ent properly coded as clinical trial services, instruct the provider to resubmit the service on a new claim with appropriate clinical trial coding. 69.9 - Billing and Processing Fee for Service Claims for Covered Clinical Trial Services Furnished to Managed Care Enrollees (Rev. 1723, Issued: 05- 01-09, Effective: 10 -01-09, Implementation: 10- 05-09) For dates of service on or after September 19, 2000, and until notified otherwise by CMS, Medicare contractors will pay for covered clinical trial services furnished to beneficiaries enrolled in managed care plans. Providers who furnish covered clinical trial services to managed care beneficiaries must be enrolled with Medicare in order to bill on a fee -for-service basis. Providers that wish to bil l fee for service but have not enrolled with Medicare must contact their local carrier, intermediary, regional home health intermediary or National Supplier Clearinghouse, as appropriate, to obtain an enrollment application. Determine payment for covered clinical trial services furnished to beneficiaries enrolled in managed care plans in accordance with applicable fee for service rules, except that beneficiaries are not responsible for the Part A or Part B deductibles (i.e., a ssume the Part A or Part B deductible has been met). Managed care enrollees are liable for the coinsurance amounts applicable to services paid under Medicare fee for service rules. The clinical trial coding requirements for managed care enrollee claims are the same as those for regular Medicare fee for service claims. However, for beneficiaries enrolled in a managed care plan, institutional providers must not bill outpatient clinica l trial services and non -clinical trial services on the same claim. If covered outpatient services unrelated to the clinical trial are rendered during the same day/stay, the provider must split- bill so that ONLY the clinical trial services are contained o n a single claim and billed as fee -for-service (this allows the Medicare claims processing system to not apply deductible when the patient is found to be in a managed care plan). Any outpatient services unrelated to the clinical trial should be billed to the managed care plan. 69.10 - CWF Editing Of Clinical Trial Claims For Managed Care Enrollees (Rev. 487, Issued: 03- 04-05, Effective and Implementation: N/A) Submit clinical trial services for managed care enrollees to CWF for payment approval. CWF will not reject clinical trial claims for managed care enrollees when all services on the claim transaction record are coded as clinical trial services and the date( s) of service is (are) on or after September 19, 2000. In addition, CWF will not apply Part B deductible to clinical trial claims for managed care enrollees (i.e., CWF will process clinical trial services for managed care enrollees as if the Part B deduct ible has already been met). 69.11 - Resolution of CWF UR 5232 Rejects (Rev. 487, Issued: 03- 04-05, Effective and Implementation: N/A) If you send a claim transaction to CWF that includes both clinical and non -clinical trial services for a managed care enrollee, the entire claim will be rejected with the UR 5232 error code. When you receive a UR 5232 error code split the claim and resubmi t the clinical trial portion to CWF. Process the non- clinical trial portion of the rejected claims in the same manner that other non -clinical trial fee for service claims for managed care enrollees are handled. 70 - Billing Requirements for Islet Cell Transplantation for Beneficiaries in a National Institutes of Health (NIH) Clinical Trial (Rev. 986, Issued: 06- 16-06, Effective: 05 -01-06, Implementation: 07- 31-06) For services performed on or after October 1, 2004, Medicare will cover islet cell transplantation for patients with Type I diabetes who are participating in an NIH sponsored clinical trial. See Pub 100 -04 (National Coverage Determinations Manual) section 260.3.1 for complete coverage policy. The islet cell transplant may be done alone or in combination with a kidney transplant. Islet recipients will also need immunosuppressant therapy to prevent rejection of the transplanted islet cells. Routine follow -up care will be necessary for each trial patient. See Pub 100- 04, section 310 for further guidance relative to routine care. All other uses for islet cell services will remain non -covered. 70.1 - Healthcare Common Procedure Coding System (HCPCS) Codes for Carriers (Rev. 261, Issued: 07- 30-04, Effective: 10 -01-04, Implementation: 10- 04-04) G0341: Percutaneous islet cell transplant, includes portal vein catheterization and infusion Short Descriptor: Percutaneous islet cell trans Type of Service: 2 G0342: Laparoscopy for islet cell transplant, includes portal vein catheterization and infusion Short Descriptor: Laparoscopy islet cell trans Type of Service: 2 G0343: Laparotomy for islet cell transplant, includes portal vein catheterization and infusion Short Descriptor: Laparotomy islet cell transp Type of Service: 2 70.2 - Applicable Modifier for Islet Cell Transplant Claims for Carriers (Rev. 986, Issued: 06- 16-06, Effective: 05 -01-06, Implementation: 07- 31-06) Carriers shall instruct physicians to bill using the above procedure code(s) with modifier QR (Item or service provided in a Medicare- specified study) for all claims for islet cell transplantation and routine follow -up care related to this service. 70.3 - Special Billing and Payment Requirements for Carriers (Rev. 261, Issued: 07- 30-04, Effective: 10 -01-04, Implementation: 10- 04-04) Payment and pricing information will be on the October 2004 update of the Medicare Physician Fee Schedule Database (MPFSDB). Pay for islet cell transplants on the basis of the MPFS. Deductible and coinsurance apply for fee -for-service beneficiaries. 70.4 - Special Billing and Payment Requirements for A/B MACs (A) (Rev. 11021; Issued: 10- 01-21; Effective: 10 -29-21; Implementation: 10 -29-21) If ICD -10 is applicable, ICD -10-PCS codes for the clinical trial are:

(Medicare Claims Processing Manual)

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Carriers shall instruct physicians to bill using the above procedure code(s) with modifier QR (Item or service provided in a Medicare- specified study) for all claims for islet cell transplantation and routine follow -up care related to this service. 70.3 - Special Billing and Payment Requirements for Carriers (Rev. 261, Issued: 07- 30-04, Effective: 10 -01-04, Implementation: 10- 04-04) Payment and pricing information will be on the October 2004 update of the Medicare Physician Fee Schedule Database (MPFSDB). Pay for islet cell transplants on the basis of the MPFS. Deductible and coinsurance apply for fee -for-service beneficiaries. 70.4 - Special Billing and Payment Requirements for A/B MACs (A) (Rev. 11021; Issued: 10- 01-21; Effective: 10 -29-21; Implementation: 10 -29-21) If ICD -10 is applicable, ICD -10-PCS codes for the clinical trial are: ICD-10-PCS Code Code Description 3E030U1 Introduction of Nonautologous Pancreatic Islet Cells into Peripheral Vein, Open Approach 3E033U1 Introduction of Nonautologous Pancreatic Islet Cells into Peripheral Vein, Percutaneous Approach 3E0J3U1 Introduction of Nonautologous Pancreatic Islet Cells into Biliary and Pancreatic Tract, Percutaneous Approach 3E0J7U1 Introduction of Nonautologous Pancreatic Islet Cells into Biliary and Pancreatic Tract, Via Natural or Artificial Opening 3E0J8U1 Introduction of Nonautologous Pancreatic Islet Cells into Biliary and Pancreatic Tract, Via Natural or Artificial Opening Endoscopic E10.9 Type 1 diabetes mellitus without complications E10.65 Type 1 diabetes mellitus with hyperglycemia E10.10 Type 1 diabetes mellitus with ketoacidosis without coma E10.69 Type 1 diabetes mellitus with other specified complication E10.21 Type 1 diabetes mellitus with diabetic nephropathy E10.22 Type 1 diabetes mellitus with diabetic chronic kidney disease E10.29 Type 1 diabetes mellitus with other diabetic kidney complication E10.311 Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edema E10.319 Type 1 diabetes mellitus with unspecified diabetic retinopathy without macular edema E10.3211 Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye E10.3212 Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye E10.3213 Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral E10.3291 Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye E10.3292 Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye E10.3293 Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral E10.3311 Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye E10.3312 Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye E10.3313 Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral E10.3391 Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye E10.3392 Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, left eye E10.3393 Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, bilateral E10.3411 Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye E10.3412 Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye E10.3413 Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral E10.3491 Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye E10.3492 Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left eye E10.3493 Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, bilateral E10.3511 Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye E10.3512 Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye E10.3513 Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral E10.3521 Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye E10.3522 Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye E10.3523 Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral E10.3531 Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye E10.3532 Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye E10.3533 Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral E10.3541 Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, right eye E10.3542 Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye E10.3543 Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral E10.3551 Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, right eye E10.3552 Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, left eye E10.3553 Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, bilateral E10.3591 Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eye E10.3592 Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eye E10.3593 Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateral E10.37x1 Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, right eye E10.37x2 Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, left eye E10.37x3 Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral E10.36 Type 1 diabetes mellitus with diabetic cataract E10.39 Type 1 diabetes mellitus with other diabetic ophthalmic complication E10.40 Type 1 diabetes mellitus with diabetic neuropathy, unspecified E10.41 Type 1 diabetes mellitus with diabetic mononeuropathy E10.42 Type 1 diabetes mellitus with diabetic polyneuropathy E10.43 Type 1 diabetes mellitus with diabetic autonomic (poly)neuropathy E10.44 Type 1 diabetes mellitus with diabetic amyotrophy E10.49 Type 1 diabetes mellitus with other diabetic neurological complication E10.610 Type 1 diabetes mellitus with diabetic neuropathic arthropathy E10.51 Type 1 diabetes mellitus with diabetic peripheral angiopathy without gangrene E10.52 Type 1 diabetes mellitus with diabetic peripheral angiopathy with gangrene E10.59 Type 1 diabetes mellitus with other circulatory complications E10.618 Type 1 diabetes mellitus with other diabetic arthropathy E10.620 Type 1 diabetes mellitus with diabetic dermatitis E10.621 Type 1 diabetes mellitus with foot ulcer E10.622 Type 1 diabetes mellitus with other skin ulcer E10.628 Type 1 diabetes mellitus with other skin complications E10.630 Type 1 diabetes mellitus with periodontal disease E10.638 Type 1 diabetes mellitus with other oral complications If ICD -10 is applicable, ICD -10-CM codes for the clinical trial are: Secondary ICD -10-CM Diagnosis requirement for Clinical Trial: Z00.6 Encounter for examination for normal comparison and control in clinical research program The applicable TOB is 11X. A secondary diagnosis (diagnoses positions 2 9) of ICD-10- CM code Z00.6 (examination of participant or control in clinical research) must be present along with condition code 30 (qualifying clinical trial) Z00.6 and condition code 30 alerts the claims processing system that this is a clinical trial. The procedure is paid under inpatient prospective payment system for hospitals with patients in the trial. Deductible and coinsurance apply for fee -for-service beneficiaries. Inpatient hospitals participating in this trial are entitled to an add -on payment of $18,848.00 for islet isolation services. This amount is in addition to the final IPPS payment made to the hospital. Should two infusions occur during the same hospital sta y, Medicare will pay for two add- ons for isolation of the islet cells, but never for more than two add- ons for a hospital stay. Inpatient hospitals shall report charges for organ acquisition in Revenue Code 0810, 0811, 0812, 0813, or 0819. This includes charges for the pre -transplant items and services related to the acquisition and delivery of the pancreatic islet cell transplants . As is Medicares policy with other organ transplants, Medicare contractors deduct acquisition charges prior to processing through the IPPS Pricer. Pancreata procured for islet cell transplant are not included in the prospective payment. They are paid on a reasonable cost basis. This is a pass- through cost for which interim payments may be made. Effective for services on or after May 1, 2006, contractors shall accept the QR modifier for islet cell transplantation follow up care when performed in an outpatient department of a hospital when the transplant was done in conjunction with an NIH -sponsore d clinical trial, and when billed on type of bill 13X or 85X. All other normal inpatient billing practices apply. 70.5 - Special Billing and Payment Requirements Medicare Advantage (MA) Beneficiaries (Rev. 261, Issued: 07- 30-04, Effective: 10 -01-04, Implementation: 10- 04-04) CMS will make payment directly on a fee -for service basis for the routine costs of pancreatic islet cell transplants as well as transplantation and appropriate related items and services, for MA beneficiaries participating in an NIH -sponsored clinical tria l. MA organizations will not be liable for payment for routine costs of this new clinical trial until MA payments can be appropriately adjusted to take into account the cost of this national coverage decision. Medicare contractors shall make payment on behalf of MA organizations directly to providers of these islet cell transplants in accordance with Medicare payment rules, except that beneficiaries are not responsible for the Part A and Part B deductibles. MA enrollees will be liable for any applicable coinsurance amounts MA organizations have in place for clinical trial benefits. E10.649 Type 1 diabetes mellitus with hypoglycemia without coma E10.8 Type 1 diabetes mellitus with unspecified complications 80 - Billing of the Diagnosis and Treatment of Peripheral Neuropathy with Loss of Protective Sensation in People with Diabetes (Rev. 498, Issued: 03- 11-05, Effective/Implementation: N/A)

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CMS will make payment directly on a fee -for service basis for the routine costs of pancreatic islet cell transplants as well as transplantation and appropriate related items and services, for MA beneficiaries participating in an NIH -sponsored clinical tria l. MA organizations will not be liable for payment for routine costs of this new clinical trial until MA payments can be appropriately adjusted to take into account the cost of this national coverage decision. Medicare contractors shall make payment on behalf of MA organizations directly to providers of these islet cell transplants in accordance with Medicare payment rules, except that beneficiaries are not responsible for the Part A and Part B deductibles. MA enrollees will be liable for any applicable coinsurance amounts MA organizations have in place for clinical trial benefits. E10.649 Type 1 diabetes mellitus with hypoglycemia without coma E10.8 Type 1 diabetes mellitus with unspecified complications 80 - Billing of the Diagnosis and Treatment of Peripheral Neuropathy with Loss of Protective Sensation in People with Diabetes (Rev. 498, Issued: 03- 11-05, Effective/Implementation: N/A) Coverage Requirements - Peripheral neuropathy is the most common factor leading to amputation in people with diabetes. In diabetes, peripheral neuropathy is an anatomically diffuse process primarily affecting sensory and autonomic fibers; however, distal motor findings may be present in advanced cases. Long nerves are affected first, with symptoms typically beginning insidiously in the toes and then advancing proximally. This leads to loss of protective sensation (LOPS), whereby a person is unable to feel minor trauma from mechanical, thermal, or chemical sources. Wh en foot lesions are present, the reduction in autonomic nerve functions may also inhibit wound healing. Peripheral neuropathy with LOPS, secondary to diabetes, is a localized illness of the feet and falls within the regulation's exception to the general exclusionary rule (see 42 C.F.R. 411.15(l)(l)(i)). Foot exams for people with diabetic peripheral neurop athy with LOPS are reasonable and necessary to allow for early intervention in serious complications that typically afflict diabetics with the disease. Effective for services furnished on or after July 1, 2002, Medicare covers, as a physician service, an evaluation (examination and treatment) of the feet no more often than every 6 months for individuals with a documented diagnosis of diabetic sensory neuropathy and LOPS, as long as the beneficiary has not seen a foot care specialist for some other reason in the interim. LOPS shall be diagnosed through sensory testing with the 5.07 monofilament using established guidelines, such as those developed by the N ational Institute of Diabetes and Digestive and Kidney Diseases guidelines. Five sites should be tested on the plantar surface of each foot, according to the National Institute of Diabetes and Digestive and Kidney Diseases guidelines. The areas must be tested randomly since the loss of protective sensation may be patchy in distribution, and the patient may get clues if the test is done rhythmically. Heavily callused areas should be avoided. As suggested by the American Podiatric Medicine Association, an absence of sensation at two or more sites out of 5 tested on either foot when tested with the 5.07 Semmes -Weinstein monofilament must be present and documented to diagnose peripheral neuropathy with loss of protective sensation. 80.1 - General Billing Requirements (Rev. 2783, Issued: 09- 10-13, Effective: 09 -30-13, Implementation: 09- 30-13) The following providers of service may bill you for these services: Hospitals; Critical Access Hospitals Rural Health Clinics; and Free-Standing Federally Qualified Health Clinics (FQHC). 80.2 - Applicable HCPCS Codes (Rev. 498, Issued: 03- 11-05, Effective/Implementation: N/A) G0245 - Initial physician evaluation and management of a diabetic patient with diabetic sensory neuropathy resulting in a loss of protective sensation (LOPS) which must include: 1. The diagnosis of LOPS; 2. A patient history; 3. A physical examination that consists of at least the following elements: (a) visual inspection of the forefoot, hindfoot, and toe web spaces, (b) evaluation of a protective sensation, (c) evaluation of foot structure and biomechanics, (d) evaluation of vascular status and skin integrity, (e) evaluation and recommendation of footwear, and 4. Patient education. G0246 - Follow -up physician evaluation and management of a diabetic patient with diabetic sensory neuropathy resulting in a loss of protective sensation (LOPS) to include at least the following: 1. a patient history; 2. a physical examination that includes: (a) visual inspection of the forefoot, hindfoot, and toe web spaces, (b) evaluation of protective sensation, (c) evaluation of foot structure and biomechanics, (d) evaluation of vascular status and skin integrity, (e) evaluation and recommendation of footwear, and 3. patient education. G0247 - Routine foot care by a physician of a diabetic patient with diabetic sensory neuropathy resulting in a LOPS to include if present, at least the following: (1) local care of superficial (i.e., superficial to muscle and fascia) wounds; (2) debridement of corns and calluses; and (3) trimming and debridement of nails. NOTE : Code G0247 must be billed on the same date of service with either G0245 or G0246 in order to be considered for payment. The short descriptors for the above HCPCS codes are as follows: G0245 INITIAL FOOT EXAM PTLOPS G0246 FOLLOWUP EVAL OF FOOT PT LOP G0247 ROUTINE FOOTCARE PT W LOPS 80.3 - Diagnosis Codes (Rev. 11021; Issued: 10-01- 21; Effective: 10 -29-21; Implementation: 10-29-21) If ICD -10-CM is applicable --Providers should report one of the following diagnosis codes in conjunction with this benefit: ICD-10-CM ICD-10 DX Description E08.40 Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified E08.42 Diabetes mellitus due to underlying condition with diabetic polyneuropathy E09.40 Drug or chemical induced diabetes mellitus with neurological complications with diabetic n E09.42 Drug or chemical induced diabetes mellitus with neurological complications with diabetic p E10.40 Type 1 diabetes mellitus with diabetic neuropathy, unspecified E10.41 Type 1 diabetes mellitus with diabetic mononeuropathy E10.42 Type 1 diabetes mellitus with diabetic polyneuropathy E10.43 Type 1 diabetes mellitus with diabetic autonomic (poly)neuropathy E10.44 Type 1 diabetes mellitus with diabetic amyotrophy E10.49 Type 1 diabetes mellitus with other diabetic neurological complication E10.610 Type 1 diabetes mellitus with diabetic neuropathic arthropathy E11.40 Type 2 diabetes mellitus with diabetic neuropathy, unspecified E11.41 Type 2 diabetes mellitus with diabetic mononeuropathy E11.42 Type 2 diabetes mellitus with diabetic polyneuropathy E11.43 Type 2 diabetes mellitus with diabetic autonomic (poly)neuropathy E11.44 Type 2 diabetes mellitus with diabetic amyotrophy E11.49 Type 2 diabetes mellitus with other diabetic neurological complication E11.610 Type 2 diabetes mellitus with diabetic neuropathic arthropathy E13.40 Other specified diabetes mellitus with diabetic neuropathy, unspecified E13.41 Other specified diabetes mellitus with diabetic mononeuropathy E13.42 Other specified diabetes mellitus with diabetic polyneuropathy E13.43 Other specified diabetes mellitus with diabetic autonomic (poly)neuropathy E13.44 Other specified diabetes mellitus with diabetic amyotrophy E13.49 Other specified diabetes mellitus with other diabetic neurological complication E13.610 Other specified diabetes mellitus with diabetic neuropathic arthropathy Coverage policy can be found in Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, section 70.2.1 Diabetic neuropathy w/ LOPs. (http://www.cms.hhs.gov/manuals/103_cov_determ/ncd103index.asp 80.4 Payment (Rev. 2783, Issued: 09- 10-13, Effective: 09-30-13, Implementation: 09-30-13) Hospital outpatient departments OPPS Critical Access Hospital (CAH) - Method I -- Reasonable cost; Method II -- Technical - reasonable cost, Professional -- 115 percent of the fee schedule Rural Health Clinics/Federally Qualified Health Centers (RHCs/FQHCs) - All inclusive rate. Deductible and coinsurance apply. While these physician services may be appropriately provided to patients of Comprehensive Outpatient Rehabilitation Facilities (CORFs), the CORF does not bill. The services are billed by the physician on a professional claim. Examples of Payment calculation: Part B Deductible Met: $900 (MPFS allowed amount) x 20 percent (co- insurance) = $720 (Medicare reimbursement). Beneficiary is responsible for $180. Part B Deductible Not met: $900 (MPFS allowed amount) - $100 (Part B deductible) = $800 x 20 percent (co-insurance) = $640 (Medicare reimbursement). Beneficiary is responsible for $260. Part B Deductible Met: $800 (actual charged amount) x 20 percent (co- insurance) = $640 (Medicare Reimbursement), beneficiary is responsible for $160 co- insurance. Part B Deductible Not Met: $800 (actual charged amount) - $100 (Part B deductible) = $700 x 20 percent (co -insurance) = $560 (Medicare reimbursement). Beneficiary is responsible for $240, ($100 Part B deductible and $140 co- insurance). Services are paid at 80 percent of the lesser of the fee schedule amount or the actual charges. This service, when furnished in an RHC/FQHC by a physician or non- physician, is considered an RHC/FQHC service. RHCs/FQHCs bill you under bill type 71X or 73X with revenue code 940 and HCPCS G0245, G0246, and G0247. Payment should not be made for this service unless the claim contains a related visit code. Therefore, install an edit in your system to assure payment is not made for revenue code 940 unless the claim also contains a visit revenue code (520 or 521). Applicable Revenue Codes The applicable revenue code is 940, except for hospitals. This service can be performed in other revenue centers such as a clinic (510) for hospitals. Therefore, instruct your hospitals to report these procedures under the revenue center where they are performed. 80.5 - Applicable Revenue Codes (Rev. 498, Issued: 03- 11-05, Effective/Implementation: N/A) The applicable revenue code is 940, except for hospitals. This service can be performed in other revenue centers such as a clinic (510) for hospitals. Therefore, instruct your hospitals to report these procedures under the revenue center where they are performed. 80.6 - Editing Instructions for A/B MACs (A) (Rev. 11021; Issued: 10- 01-21; Effective: 10 -29-21; Implementation: 10 -29-21) Edit 1 - Implement diagnosis to procedure code edits to allow payment only for the LOPS codes, G0245, G0246, and G0247 when submitted with one of the following ICD-10-CM diagnosis codes If ICD -10-CM is applicable:

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Applicable Revenue Codes The applicable revenue code is 940, except for hospitals. This service can be performed in other revenue centers such as a clinic (510) for hospitals. Therefore, instruct your hospitals to report these procedures under the revenue center where they are performed. 80.5 - Applicable Revenue Codes (Rev. 498, Issued: 03- 11-05, Effective/Implementation: N/A) The applicable revenue code is 940, except for hospitals. This service can be performed in other revenue centers such as a clinic (510) for hospitals. Therefore, instruct your hospitals to report these procedures under the revenue center where they are performed. 80.6 - Editing Instructions for A/B MACs (A) (Rev. 11021; Issued: 10- 01-21; Effective: 10 -29-21; Implementation: 10 -29-21) Edit 1 - Implement diagnosis to procedure code edits to allow payment only for the LOPS codes, G0245, G0246, and G0247 when submitted with one of the following ICD-10-CM diagnosis codes If ICD -10-CM is applicable: ICD-10-CM ICD-10 DX Description E08.40 Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified E08.42 Diabetes mellitus due to underlying condition with diabetic polyneuropathy E09.40 Drug or chemical induced diabetes mellitus with neurological complications with diabetic n E09.42 Drug or chemical induced diabetes mellitus with neurological complications with diabetic p E10.40 Type 1 diabetes mellitus with diabetic neuropathy, unspecified E10.41 Type 1 diabetes mellitus with diabetic mononeuropathy E10.42 Type 1 diabetes mellitus with diabetic polyneuropathy E10.43 Type 1 diabetes mellitus with diabetic autonomic (poly)neuropathy E10.44 Type 1 diabetes mellitus with diabetic amyotrophy E10.49 Type 1 diabetes mellitus with other diabetic neurological complication E10.610 Type 1 diabetes mellitus with diabetic neuropathic arthropathy E11.40 Type 2 diabetes mellitus with diabetic neuropathy, unspecified E11.41 Type 2 diabetes mellitus with diabetic mononeuropathy E11.42 Type 2 diabetes mellitus with diabetic polyneuropathy E11.43 Type 2 diabetes mellitus with diabetic autonomic (poly)neuropathy E11.44 Type 2 diabetes mellitus with diabetic amyotrophy E11.49 Type 2 diabetes mellitus with other diabetic neurological complication E11.610 Type 2 diabetes mellitus with diabetic neuropathic arthropathy E13.40 Other specified diabetes mellitus with diabetic neuropathy, unspecified E13.41 Other specified diabetes mellitus with diabetic mononeuropathy E13.42 Other specified diabetes mellitus with diabetic polyneuropathy E13.43 Other specified diabetes mellitus with diabetic autonomic (poly)neuropathy E13.44 Other specified diabetes mellitus with diabetic amyotrophy E13.49 Other specified diabetes mellitus with other diabetic neurological complication E13.610 Other specified diabetes mellitus with diabetic neuropathic arthropathy Deny these services when submitted without one of the appropriate diagnoses. Use the same messages you currently use for procedure to diagnosis code denials. Edit 2 Deny G0247 if it is not submitted on the same claim as G0245 or G0246. Use MSN 21.21 - This service was denied because Medicare only covers this service under certain circumstances. Use RA claim adjustment reason code 107 - The related or qualifying claim/service was not identified on this claim. NOTE: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. 80.7 - CWF General Information (Rev. 4203, Issued: 01- 18-19, Effective: 02-19-19, Implementation: 02-19-19) The term Medicare beneficiary identifier (Mbi) is a general term describing a beneficiary's Medicare identification number. For purposes of this manual, Medicare beneficiary identifier references both the Health Insurance Claim Number (HICN) and the Medicare Beneficiary Identifier (MBI) during the new Medicare card transition period and after for certain business areas that will continue to use the HICN as part of their processes. Though G0245 and G0246 have no technical or professional components, for these codes, CWF will post institutional claims with type of bill 13X as technical, and professional claims as professional. For bill type 85X with revenue code 940, CWF will post as technical. For 85X bill type with revenue code 98X, (Method II), CWF will post as technical and professional. This will allow both the facility and professional service payments to be approved by CWF for payment when the code and date of service match. Therefore, should a claim be received with the same code and same date of service for the same beneficiary, the second claim submitted will not be rejected as a duplicate. Due to the billing and payment methodology of Rural Health Clinics - bill type 71X and Federally Qualified Health Centers - bill type 73X, CWF will post these claims as usual, which will correctly allow claims from these entities that are billed on institu tional claims to reject as duplicates when the HCPCS code, date of service, and Medicare beneficiary identifier are an exact match with a claim billed on a professional claim. Medicare contractors must react to these duplicate claims as they currently do for any other duplicates. 80.8 - CWF Utilization Edits (Rev. 1742, Issued: 05- 22-09, Effective: 06-08-09, Implementation: 06-08-09) Edit 1 - Should CWF receive a claim from an FI for G0245 or G0246 and a second claim from a contractor for either G0245 or G0246 (or vice versa) and they are different dates of service and less than 6 months apart, the second claim will reject. CWF will edit to allow G0245 or G0246 to be paid no more than every 6 months for a particular beneficiary, regardless of who furnished the service. If G0245 has been paid, regardless of whether it was posted as a facility or professional claim, it must be 6 months before G0245 can be paid again or G0246 can be paid. If G0246 has been paid, regardless of whether it was posted as a facility or professional claim, it must be 6 months before G0246 can be paid again or G0245 can be paid. CWF will not impose limits on how man y times each code can be paid for a beneficiary as long as there has been 6 months between each service. The CWF will return a specific reject code for this edit to the contractors and FIs that will be identified in the CWF documentation. Based on the CWF reject code, the contractors and FIs must deny the claims and return the following messages: MSN 18.4 -- This service is being denied because it has not been __ months since your last examination of this kind (NOTE : Insert 6 as the appropriate number of months.) RA claim adjustment reason code 96 Non -covered charges, along with remark code M86 Service denied because payment already made for same/similar procedure within set time frame. Edit 2 The CWF will edit to allow G0247 to pay only if either G0245 or G0246 has been submitted and accepted as payable on the same date of service. CWF will return a specific reject code for this edit to the contractors and FIs that will be identified in the CWF documentation. Based on this reject code, contractors and FIs will deny the claims and return the following m essages: MSN 21.21 - This service was denied because Medicare only covers this service under certain circumstances. RA claim adjustment reason code 107 The related or qualifying claim/service was not identified on this claim. Edit 3 Once a beneficiarys condition has progressed to the point where routine foot care becomes a covered service, payment will no longer be made for LOPS evaluation and management services. Those services would be considered to be included in the regular exams and treatments afforded to the beneficiary on a routine basis. The physician or provider must then just bill the routine foot care codes, per Pub 100-02, Chapter 15, 290. The CWF will edit to reject LOPS codes G0245, G0246, and/or G0247 when on the beneficiarys record it shows that one of the following routine foot care codes were billed and paid within the prior 6 months: 11055, 11056, 11057, 11719, 11720, and/or 11721. The CWF will return a specific reject code for this edit to the contractors and FIs that will be identified in the CWF documentation. Based on the CWF reject code, the contractors and FIs must deny the claims and return the following messages: MSN 21.21 - This service was denied because Medicare only covers this service under certain circumstances. The RA claim adjustment reason code 96 Non -covered charges, along with remark code M86 Service denied because payment already made for same/similar procedure within set time frame. 90 - Stem Cell Transplantation (Rev.12533; Issued: 03 -07-24 Effective: 04 -08-24; Implementation:04 -08-24) A. General Stem cell transplantation is a process in which stem cells are harvested from either a patients (autologous) or donors (allogeneic) bone marrow or peripheral blood for intravenous infusion. Allogeneic and autologous stem cell transplants are covered under Medicare for specific diagnoses. See Pub. 100-03, National Coverage Determinations Manual, section 110.23, for a complete description of covered and noncovered conditions. For Part A hospital inpatient claims processing instructions, refer to Pub. 100-04, chapter 3, section 90. The following sections contain claims processing instructions for all other claims. B. Nationally Covered Indications C. Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) ICD- 10-PCS Procedure Codes 30230G2 Transfusion of Allogeneic Related Bone Marrow into Peripheral Vein, Open Approach 30230G3 Transfusion of Allogeneic Unrelated Bone Marrow into Peripheral Vein, Open Approach 30233U2 Transfusion of Allogeneic Related T -cell Depleted Hematopoietic Stem Cells into Peripheral Vein, Percutaneous Approach 30233U3 Transfusion of Allogeneic Unrelated T -cell Depleted Hematopoietic Stem Cells into Peripheral Vein, Percutaneous Approach 30230Y2 Transfusion of Allogeneic Related Hematopoietic Stem Cells into Peripheral Vein, Open Approach 30230Y3 Transfusion of Allogeneic Unrelated Hematopoietic Stem Cells into Peripheral Vein, Open Approach 30233G2 Transfusion of Allogeneic Related Bone Marrow into Peripheral Vein, Percutaneous Approach 30233G3 Transfusion of Allogeneic Unrelated Bone Marrow into Peripheral Vein, Percutaneous Approach 30243U2 Transfusion of Allogeneic Related T -cell Depleted Hematopoietic Stem Cells into Central Vein, Percutaneous Approach 30243U3 Percutaneous Approach 30233Y2 Transfusion of Allogeneic Related Hematopoietic Stem Cells into Peripheral Vein, Percutaneous Approach 30233Y3 Transfusion of Allogeneic Unrelated Hematopoietic Stem Cells into Peripheral Vein, Percutaneous Approach 30240G2 Transfusion of Allogeneic Related Bone Marrow into Central Vein, Open Approach 30240G3 Transfusion of Allogeneic Unrelated Bone Marrow into Central Vein, Open Approach 30240Y2 Transfusion of Allogeneic Related Hematopoietic Stem Cells into Central Vein, Open Approach 30240Y3 Transfusion of Allogeneic Unrelated Hematopoietic Stem Cells into Central Vein, Open Approach 30243G2 Transfusion of Allogeneic Related Bone Marrow into Central Vein, Percutaneous Approach 30243G3 Transfusion of Allogeneic Unrelated Bone Marrow into Central Vein, Percutaneous Approach 30243Y2 Transfusion of Allogeneic Related Hematopoietic Stem Cells into Central Vein, Percutaneous Approach 30243Y3 Transfusion of Allogeneic Unrelated Hematopoietic Stem Cells into Central Vein, Percutaneous Approach HCPCS Code 38240 See below table for ICD-10-DX Codes:

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HCPCS Code 38240 See below table for ICD-10-DX Codes: a. Effective for services performed on or after August 1, 1978: a. For the treatment of leukemia, leukemia in remission; see table below for ICD - 10-CM codes: C91.00 Acute lymphoblastic leukemia not having achieved remission C91.01 Acute lymphoblastic leukemia, in remission C91.02 Acute lymphoblastic leukemia, in relapse C91.10 Chronic lymphocytic leukemia of B-cell type not having achieved remission C91.11 Chronic lymphocytic leukemia of B-cell type in remission C91.12 Chronic lymphocytic leukemia of B-cell type in relapse C91.30 Prolymphocytic leukemia of B-cell type not having achieved remission C91.31 Prolymphocytic leukemia of B-cell type, in remission C91.32 Prolymphocytic leukemia of B-cell type, in relapse C91.50 Adult T-cell lymphoma/leukemia (HTLV -1-associated) not having achieved remission C91.51 Adult T-cell lymphoma/leukemia (HTLV -1-associated), in remission C91.52 Adult T-cell lymphoma/leukemia (HTLV -1-associated), in relapse C91.60 Prolymphocytic leukemia of T-cell type not having achieved remission C91.61 Prolymphocytic leukemia of T-cell type, in remission C91.62 Prolymphocytic leukemia of T-cell type, in relapse C91.90 Lymphoid leukemia, unspecified not having achieved remission C91.91 Lymphoid leukemia, unspecified, in remission C91.92 Lymphoid leukemia, unspecified, in relapse C91.A0 Mature B-cell leukemia Burkitt -type not having achieved remission C91.A1 Mature B-cell leukemia Burkitt -type, in remission C91.A2 Mature B-cell leukemia Burkitt -type, in relapse C91.Z0 Other lymphoid leukemia not having achieved remission C91.Z1 Other lymphoid leukemia, in remission C91.Z2 Other lymphoid leukemia, in relapse C92.00 Acute myeloblastic leukemia, not having achieved remission C92.01 Acute myeloblastic leukemia, in remission C92.02 Acute myeloblastic leukemia, in relapse C92.10 Chronic myeloid leukemia, BCR/ABL -positive, not having achieved remission C92.11 Chronic myeloid leukemia, BCR/ABL -positive, in remission C92.12 Chronic myeloid leukemia, BCR/ABL -positive, in relapse C92.20 Atypical chronic myeloid leukemia, BCR/ABL -negative, not having achieved remission C92.21 Atypical chronic myeloid leukemia, BCR/ABL -negative, in remission C92.22 Atypical chronic myeloid leukemia, BCR/ABL -negative, in relapse C92.30 Myeloid sarcoma, not having achieved remission C92.31 Myeloid sarcoma, in remission C92.32 Myeloid sarcoma, in relapse C92.40 Acute promyelocytic leukemia, not having achieved remission C92.41 Acute promyelocytic leukemia, in remission C92.42 Acute promyelocytic leukemia, in relapse C92.50 Acute myelomonocytic leukemia, not having achieved remission C92.51 Acute myelomonocytic leukemia, in remission C92.52 Acute myelomonocytic leukemia, in relapse C92.60 Acute myeloid leukemia with 11q23 -abnormality not having achieved remission C92.61 Acute myeloid leukemia with 11q23 -abnormality in remission C92.62 Acute myeloid leukemia with 11q23 -abnormality in relapse C92.90 Myeloid leukemia, unspecified, not having achieved remission C92.91 Myeloid leukemia, unspecified in remission C92.92 Myeloid leukemia, unspecified in relapse C92.A0 Acute myeloid leukemia with multilineage dysplasia, not having achieved remission C92.A1 Acute myeloid leukemia with multilineage dysplasia, in remission C92.A2 Acute myeloid leukemia with multilineage dysplasia, in relapse C92.Z0 Other myeloid leukemia not having achieved remission C92.Z1 Other myeloid leukemia, in remission C92.Z2 Other myeloid leukemia, in relapse C93.00 Acute monoblastic/monocytic leukemia, not having achieved remission C93.01 Acute monoblastic/monocytic leukemia, in remission C93.02 Acute monoblastic/monocytic leukemia, in relapse C93.10 Chronic myelomonocytic leukemia not having achieved remission C93.11 Chronic myelomonocytic leukemia, in remission C93.12 Chronic myelomonocytic leukemia, in relapse C93.30 Juvenile myelomonocytic leukemia, not having achieved remission C93.31 Juvenile myelomonocytic leukemia, in remission C93.32 Juvenile myelomonocytic leukemia, in relapse C93.90 Monocytic leukemia, unspecified, not having achieved remission C93.91 Monocytic leukemia, unspecified in remission C93.92 Monocytic leukemia, unspecified in relapse C93.Z0 Other monocytic leukemia, not having achieved remission C93.Z1 Other monocytic leukemia, in remission C93.Z2 Other monocytic leukemia, in relapse C94.00 Acute erythroid leukemia, not having achieved remission C94.01 Acute erythroid leukemia, in remission C94.02 Acute erythroid leukemia, in relapse C94.20 Acute megakaryoblastic leukemia not having achieved remission C94.21 Acute megakaryoblastic leukemia, in remission C94.22 Acute megakaryoblastic leukemia, in relapse C94.30 Mast cell leukemia not having achieved remission C94.31 Mast cell leukemia, in remission C94.32 Mast cell leukemia, in relapse C94.80 Other specified leukemias not having achieved remission C94.81 Other specified leukemias, in remission C94.82 Other specified leukemias, in relapse C95.00 Acute leukemia of unspecified cell type not having achieved remission C95.01 Acute leukemia of unspecified cell type, in remission C95.02 Acute leukemia of unspecified cell type, in relapse C95.10 Chronic leukemia of unspecified cell type not having achieved remission C95.11 Chronic leukemia of unspecified cell type, in remission C95.12 Chronic leukemia of unspecified cell type, in relapse C95.90 Leukemia, unspecified not having achieved remission C95.91 Leukemia, unspecified, in remission C95.92 Leukemia, unspecified, in relapse D45 Polycythemia vera ii. For the treatment of aplastic anemia; see table below for ICD -10- CM codes) ICD-10 Description D60.0 Chronic acquired pure red cell aplasia D60.1 Transient acquired pure red cell aplasia D60.8 Other acquired pure red cell aplasias D60.9 Acquired pure red cell aplasia, unspecified D61.01 Constitutional (pure) red blood cell aplasia D61.09 Other constitutional aplastic anemia D61.1 Drug -induced aplastic anemia D61.2 Aplastic anemia due to other external agents D61.3 Idiopathic aplastic anemia D61.810 Antineoplastic chemotherapy induced pancytopenia D61.811 Other drug-induced pancytopenia D61.818 Other pancytopenia D61.82 Myelophthisis D61.89 Other specified aplastic anemias and other bone marrow failure syndromes D61.9 Aplastic anemia, unspecified b. Effective for services performed on or after June 3, 1985: c. For the treatment of severe combined immunodeficiency disease (SCID) (ICD -10-CM codes D81.0, D81.1, D81.2, D81.6, D81.7, D81.89, and D81.9) d. For the treatment of Wiskott -Aldrich syndrome ( ICD -10- CM code D82.0) c. Effective for services performed on or after August 4, 2010: For the treatment of Myelodysplastic Syndromes (MDS) (ICD -10- CM codes D46.A, D46.B, D46.C, D46.Z, D46.0, D46.1, D46.4, D46.9, D46.20, D46.21, D46.22, and Z00.6) pursuant to Coverage with Evidence Development (CED) in the context of a Medicare - approved, prospective clinical study. Refer to Pub. 100- 03, NCD Manual, chapter 1, section 110.23, for further information about this policy. See section F below for billing instructions. d. Effective for services performed on or after January 27, 2016: b. Allogeneic HSCT for multiple myeloma (ICD -10-CM codes C90.00, C90.01, C90.02, and Z00.6) is covered by Medicare only for beneficiaries with Durie -Salmon Stage II or III multiple myeloma, or International Staging System (ISS) Stage II or Stage III multiple myeloma, and participating in an approved prospective clinical study. Refer to Pub. 100- 03, NCD Manual, chapter 1, section 110.23, for further information about this policy. See section F below for billing instructions. e. Allogeneic HSCT for myelofibrosis (MF) (ICD -10-CM codes C94.40, C94.41, C94.42, D47.1, D47.4, D75.81, and Z00.6) is covered by Medicare only for beneficiaries with Dynamic International Prognostic Scoring System (DIPSSplus) intermediate -2 or High primary or secondary MF and participating in an approved prospective clinical study. Refer to Pub. 100- 03, NCD Manual, chapter 1, section 110.23, for further information about this policy. See section F below for billing instructions.

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System (ISS) Stage II or Stage III multiple myeloma, and participating in an approved prospective clinical study. Refer to Pub. 100- 03, NCD Manual, chapter 1, section 110.23, for further information about this policy. See section F below for billing instructions. e. Allogeneic HSCT for myelofibrosis (MF) (ICD -10-CM codes C94.40, C94.41, C94.42, D47.1, D47.4, D75.81, and Z00.6) is covered by Medicare only for beneficiaries with Dynamic International Prognostic Scoring System (DIPSSplus) intermediate -2 or High primary or secondary MF and participating in an approved prospective clinical study. Refer to Pub. 100- 03, NCD Manual, chapter 1, section 110.23, for further information about this policy. See section F below for billing instructions. f. Allogeneic HSCT for sickle cell disease (SCD) (ICD -10-CM codes D57.00, D57.01, D57.02, D57.03, D57.09, D57.1, D57.20, D57.211, D57.212, D57.213, D57.218, D57.219, D57.40, D57.411, D57.412, D57.413, D57.418, D57.419, D57.42, D57.431, D57.432, D57.433, D57.438, D57.439, D57.44, D57.451, D57.452, D57.453, D57.458, D57.459, D57.80, D57.811,D57.812, D57.813, D57.818, D57.819, and Z00.6) is covered by Medicare only for beneficiaries with severe, symptomatic SCD who participate in an approved prospective clinical study. Refer to Pub.100- 03, NCD Manual, chapter 1, section 110.23, for further i nformation about this policy. See section F below for billing instructions. II. Autologous Stem Cell Transplantation (AuSCT) HCPCS Code 38241 ICD-10-PCS Procedure Codes: 30230C0 Transfusion of Autologous Hematopoietic Stem/Progenitor Cells, Genetically Modified into Peripheral Vein, Open Approach 30230G0 Transfusion of Autologous Bone Marrow into Peripheral Vein, Open Approach 30230Y0 Transfusion of Autologous Hematopoietic Stem Cells into Peripheral Vein, Open Approach 30233G0 Transfusion of Autologous Bone Marrow into Peripheral Vein, Percutaneous Approach 30233C0 Transfusion of Autologous Hematopoietic Stem/Progenitor Cells, Genetically Modified into Peripheral Vein, Percutaneous Approach 30233Y0 Transfusion of Autologous Hematopoietic Stem Cells into Peripheral Vein, Percutaneous Approach 30240C0 Transfusion of Autologous Hematopoietic Stem/Progenitor Cells, Genetically Modified into Central Vein, Open Approach 30240G0 Transfusion of Autologous Bone Marrow into Central Vein, Open Approach 30240Y0 Transfusion of Autologous Hematopoietic Stem Cells into Central Vein, Open Approach 30243C0 Transfusion of Autologous Hematopoietic Stem/Progenitor Cells, Genetically Modified into Central Vein, Percutaneous Approach 30243G0 Transfusion of Autologous Bone Marrow into Central Vein, Percutaneous Approach 30243Y0 Transfusion of Autologous Hematopoietic Stem Cells into Central Vein, Percutaneous Approach Below ICD -10 CM codes Cover autologous SCT (38241) no trial for acute leukemia in remission, resistant non- Hodgkins lymphomas, recurrent/refractory neuroblastoma, advanced Hodgkins Disease on or after 4/28/89, and Cover autologous SCT (38241) no trial for Durie -Salmon stage II/III responsive multiple myeloma and responsive relapse on or after 10/1/00 over autologous SCT (38241) together with high dose melphalan (HDMI) no trial for primary amyloid light chain (AL) amyloidosis on or after 3/15/05

(Medicare Claims Processing Manual)

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clm104c32.pdf

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C81.01 Nodular lymphocyte predominant Hodgkin lymphoma, lymph nodes of head, face, and neck C81.02 Nodular lymphocyte predominant Hodgkin lymphoma, intrathoracic lymph nodes C81.03 Nodular lymphocyte predominant Hodgkin lymphoma, intra - abdominal lymph nodes C81.04 Nodular lymphocyte predominant Hodgkin lymphoma, lymph nodes of axilla and upper limb C81.05 Nodular lymphocyte predominant Hodgkin lymphoma, lymph nodes of inguinal region and lower limb C81.06 Nodular lymphocyte predominant Hodgkin lymphoma, intrapelvic lymph nodes C81.07 Nodular lymphocyte predominant Hodgkin lymphoma, spleen C81.08 Nodular lymphocyte predominant Hodgkin lymphoma, lymph nodes of multiple sites C81.09 Nodular lymphocyte predominant Hodgkin lymphoma, extranodal and solid organ sites C81.11 Nodular sclerosis Hodgkin lymphoma, lymph nodes of head, face, and neck C81.12 Nodular sclerosis Hodgkin lymphoma, intrathoracic lymph nodes C81.13 Nodular sclerosis Hodgkin lymphoma, intra-abdominal lymph nodes C81.14 Nodular sclerosis Hodgkin lymphoma, lymph nodes of axilla and upper limb C81.15 Nodular sclerosis Hodgkin lymphoma, lymph nodes of inguinal region and lower limb C81.16 Nodular sclerosis Hodgkin lymphoma, intrapelvic lymph nodes C81.17 Nodular sclerosis Hodgkin lymphoma, spleen C81.18 Nodular sclerosis Hodgkin lymphoma, lymph nodes of multiple sites C81.19 Nodular sclerosis Hodgkin lymphoma, extranodal and solid organ sites C81.21 Mixed cellularity Hodgkin lymphoma, lymph nodes of head, face, and neck C81.22 Mixed cellularity Hodgkin lymphoma, intrathoracic lymph nodes C81.23 Mixed cellularity Hodgkin lymphoma, intra-abdominal lymph nodes C81.24 Mixed cellularity Hodgkin lymphoma, lymph nodes of axilla and upper limb C81.25 Mixed cellularity Hodgkin lymphoma, lymph nodes of inguinal region and lower limb C81.26 Mixed cellularity Hodgkin lymphoma, intrapelvic lymph nodes C81.27 Mixed cellularity Hodgkin lymphoma, spleen C81.28 Mixed cellularity Hodgkin lymphoma, lymph nodes of multiple sites C81.29 Mixed cellularity Hodgkin lymphoma, extranodal and solid organ sites C81.31 Lymphocyte depleted Hodgkin lymphoma, lymph nodes of head, face, and neck C81.32 Lymphocyte depleted Hodgkin lymphoma, intrathoracic lymph nodes C81.33 Lymphocyte depleted Hodgkin lymphoma, intra -abdominal lymph nodes C81.34 Lymphocyte depleted Hodgkin lymphoma, lymph nodes of axilla and upper limb C81.35 Lymphocyte depleted Hodgkin lymphoma, lymph nodes of inguinal region and lower limb C81.36 Lymphocyte depleted Hodgkin lymphoma, intrapelvic lymph nodes C81.37 Lymphocyte depleted Hodgkin lymphoma, spleen C81.38 Lymphocyte depleted Hodgkin lymphoma, lymph nodes of multiple sites C81.39 Lymphocyte depleted Hodgkin lymphoma, extranodal and solid organ sites C81.41 Lymphocyte -rich Hodgkin lymphoma, lymph nodes of head, face, and neck C81.42 Lymphocyte -rich Hodgkin lymphoma, intrathoracic lymph nodes C81.43 Lymphocyte -rich Hodgkin lymphoma, intra-abdominal lymph nodes C81.44 Lymphocyte -rich Hodgkin lymphoma, lymph nodes of axilla and upper limb C81.45 Lymphocyte -rich Hodgkin lymphoma, lymph nodes of inguinal region and lower limb C81.46 Lymphocyte -rich Hodgkin lymphoma, intrapelvic lymph nodes C81.47 Lymphocyte -rich Hodgkin lymphoma, spleen C81.48 Lymphocyte -rich Hodgkin lymphoma, lymph nodes of multiple sites C81.49 Lymphocyte -rich Hodgkin lymphoma, extranodal and solid organ sites C81.71 Other Hodgkin lymphoma, lymph nodes of head, face, and neck C81.72 Other Hodgkin lymphoma, intrathoracic lymph nodes C81.73 Other Hodgkin lymphoma, intra-abdominal lymph nodes C81.74 Other Hodgkin lymphoma, lymph nodes of axilla and upper limb C81.75 Other Hodgkin lymphoma, lymph nodes of inguinal region and lower limb C81.76 Other Hodgkin lymphoma, intrapelvic lymph nodes C81.77 Other Hodgkin lymphoma, spleen C81.78 Other Hodgkin lymphoma, lymph nodes of multiple sites C81.91 Hodgkin lymphoma, unspecified, lymph nodes of head, face, and neck C81.92 Hodgkin lymphoma, unspecified, intrathoracic lymph nodes C81.93 Hodgkin lymphoma, unspecified, intra-abdominal lymph nodes C81.94 Hodgkin lymphoma, unspecified, lymph nodes of axilla and upper limb C81.95 Hodgkin lymphoma, unspecified, lymph nodes of inguinal region and lower limb C81.96 Hodgkin lymphoma, unspecified, intrapelvic lymph nodes C81.97 Hodgkin lymphoma, unspecified, spleen C81.98 Hodgkin lymphoma, unspecified, lymph nodes of multiple sites C81.99 Hodgkin lymphoma, unspecified, extranodal and solid organ sites C82.01 Follicular lymphoma grade I, lymph nodes of head, face, and neck C82.02 Follicular lymphoma grade I, intrathoracic lymph nodes C82.03 Follicular lymphoma grade I, intra-abdominal lymph nodes C82.04 Follicular lymphoma grade I, lymph nodes of axilla and upper limb C82.05 Follicular lymphoma grade I, lymph nodes of inguinal region and lower limb C82.06 Follicular lymphoma grade I, intrapelvic lymph nodes C82.07 Follicular lymphoma grade I, spleen C82.08 Follicular lymphoma grade I, lymph nodes of multiple sites C82.09 Follicular lymphoma grade I, extranodal and solid organ sites C82.11 Follicular lymphoma grade II, lymph nodes of head, face, and neck C82.12 Follicular lymphoma grade II, intrathoracic lymph nodes C82.13 Follicular lymphoma grade II, intra-abdominal lymph nodes C82.14 Follicular lymphoma grade II, lymph nodes of axilla and upper limb C82.15 Follicular lymphoma grade II, lymph nodes of inguinal region and lower limb C82.16 Follicular lymphoma grade II, intrapelvic lymph nodes C82.17 Follicular lymphoma grade II, spleen C82.18 Follicular lymphoma grade II, lymph nodes of multiple sites C82.19 Follicular lymphoma grade II, extranodal and solid organ sites C82.21 Follicular lymphoma grade III, unspecified, lymph nodes of head, face, and neck C82.22 Follicular lymphoma grade III, unspecified, intrathoracic lymph nodes C82.23 Follicular lymphoma grade III, unspecified, intra -abdominal lymph nodes C82.24 Follicular lymphoma grade III, unspecified, lymph nodes of axilla and upper limb C82.25 Follicular lymphoma grade III, unspecified, lymph nodes of inguinal region and lower limb C82.26 Follicular lymphoma grade III, unspecified, intrapelvic lymph nodes C82.27 Follicular lymphoma grade III, unspecified, spleen C82.28 Follicular lymphoma grade III, unspecified, lymph nodes of multiple sites C82.29 Follicular lymphoma grade III, unspecified, extranodal and solid organ sites C82.31 Follicular lymphoma grade IIIa, lymph nodes of head, face, and neck C82.32 Follicular lymphoma grade IIIa, intrathoracic lymph nodes C82.33 Follicular lymphoma grade IIIa, intra-abdominal lymph nodes C82.34 Follicular lymphoma grade IIIa, lymph nodes of axilla and upper limb C82.35 Follicular lymphoma grade IIIa, lymph nodes of inguinal region and lower limb C82.36 Follicular lymphoma grade IIIa, intrapelvic lymph nodes C82.37 Follicular lymphoma grade IIIa, spleen C82.38 Follicular lymphoma grade IIIa, lymph nodes of multiple sites C82.39 Follicular lymphoma grade IIIa, extranodal and solid organ sites C82.41 Follicular lymphoma grade IIIb, lymph nodes of head, face, and neck C82.42 Follicular lymphoma grade IIIb, intrathoracic lymph nodes C82.43 Follicular lymphoma grade IIIb, intra-abdominal lymph nodes C82.44 Follicular lymphoma grade IIIb, lymph nodes of axilla and upper limb C82.45 Follicular lymphoma grade IIIb, lymph nodes of inguinal region and lower limb C82.46 Follicular lymphoma grade IIIb, intrapelvic lymph nodes C82.47 Follicular lymphoma grade IIIb, spleen C82.48 Follicular lymphoma grade IIIb, lymph nodes of multiple sites C82.49 Follicular lymphoma grade IIIb, extranodal and solid organ sites C82.51 Diffuse follicle center lymphoma, lymph nodes of head, face, and neck C82.52 Diffuse follicle center lymphoma, intrathoracic lymph nodes C82.53 Diffuse follicle center lymphoma, intra-abdominal lymph nodes C82.54 Diffuse follicle center lymphoma, lymph nodes of axilla and upper limb C82.55 Diffuse follicle center lymphoma, lymph nodes of inguinal region and lower limb C82.56 Diffuse follicle center lymphoma, intrapelvic lymph nodes C82.57

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C82.45 Follicular lymphoma grade IIIb, lymph nodes of inguinal region and lower limb C82.46 Follicular lymphoma grade IIIb, intrapelvic lymph nodes C82.47 Follicular lymphoma grade IIIb, spleen C82.48 Follicular lymphoma grade IIIb, lymph nodes of multiple sites C82.49 Follicular lymphoma grade IIIb, extranodal and solid organ sites C82.51 Diffuse follicle center lymphoma, lymph nodes of head, face, and neck C82.52 Diffuse follicle center lymphoma, intrathoracic lymph nodes C82.53 Diffuse follicle center lymphoma, intra-abdominal lymph nodes C82.54 Diffuse follicle center lymphoma, lymph nodes of axilla and upper limb C82.55 Diffuse follicle center lymphoma, lymph nodes of inguinal region and lower limb C82.56 Diffuse follicle center lymphoma, intrapelvic lymph nodes C82.57 Diffuse follicle center lymphoma, spleen C82.58 Diffuse follicle center lymphoma, lymph nodes of multiple sites C82.59 Diffuse follicle center lymphoma, extranodal and solid organ sites C82.61 Cutaneous follicle center lymphoma, lymph nodes of head, face, and neck C82.62 Cutaneous follicle center lymphoma, intrathoracic lymph nodes C82.63 Cutaneous follicle center lymphoma, intra-abdominal lymph nodes C82.64 Cutaneous follicle center lymphoma, lymph nodes of axilla and upper limb C82.65 Cutaneous follicle center lymphoma, lymph nodes of inguinal region and lower limb C82.66 Cutaneous follicle center lymphoma, intrapelvic lymph nodes C82.67 Cutaneous follicle center lymphoma, spleen C82.68 Cutaneous follicle center lymphoma, lymph nodes of multiple sites C82.69 Cutaneous follicle center lymphoma, extranodal and solid organ sites C82.81 Other types of follicular lymphoma, lymph nodes of head, face, and neck C82.82 Other types of follicular lymphoma, intrathoracic lymph nodes C82.83 Other types of follicular lymphoma, intra -abdominal lymph nodes C82.84 Other types of follicular lymphoma, lymph nodes of axilla and upper limb C82.85 Other types of follicular lymphoma, lymph nodes of inguinal region and lower limb C82.86 Other types of follicular lymphoma, intrapelvic lymph nodes C82.87 Other types of follicular lymphoma, spleen C82.88 Other types of follicular lymphoma, lymph nodes of multiple sites C82.89 Other types of follicular lymphoma, extranodal and solid organ sites C82.91 Follicular lymphoma, unspecified, lymph nodes of head, face, and neck C82.92 Follicular lymphoma, unspecified, intrathoracic lymph nodes C82.93 Follicular lymphoma, unspecified, intra-abdominal lymph nodes C82.94 Follicular lymphoma, unspecified, lymph nodes of axilla and upper limb C82.95 Follicular lymphoma, unspecified, lymph nodes of inguinal region and lower limb C82.96 Follicular lymphoma, unspecified, intrapelvic lymph nodes C82.97 Follicular lymphoma, unspecified, spleen C82.98 Follicular lymphoma, unspecified, lymph nodes of multiple sites C82.99 Follicular lymphoma, unspecified, extranodal and solid organ sites C83.01 Small cell B-cell lymphoma, lymph nodes of head, face, and neck C83.02 Small cell B-cell lymphoma, intrathoracic lymph nodes C83.03 Small cell B-cell lymphoma, intra-abdominal lymph nodes C83.04 Small cell B-cell lymphoma, lymph nodes of axilla and upper limb C83.05 Small cell B-cell lymphoma, lymph nodes of inguinal region and lower limb C83.06 Small cell B-cell lymphoma, intrapelvic lymph nodes C83.07 Small cell B-cell lymphoma, spleen C83.08 Small cell B-cell lymphoma, lymph nodes of multiple sites C83.09 Small cell B-cell lymphoma, extranodal and solid organ sites C83.11 Mantle cell lymphoma, lymph nodes of head, face, and neck C83.12 Mantle cell lymphoma, intrathoracic lymph nodes C83.13 Mantle cell lymphoma, intra-abdominal lymph nodes C83.14 Mantle cell lymphoma, lymph nodes of axilla and upper limb C83.15 Mantle cell lymphoma, lymph nodes of inguinal region and lower limb C83.16 Mantle cell lymphoma, intrapelvic lymph nodes C83.17 Mantle cell lymphoma, spleen C83.18 Mantle cell lymphoma, lymph nodes of multiple sites C83.19 Mantle cell lymphoma, extranodal and solid organ sites C83.31 Diffuse large B-cell lymphoma, lymph nodes of head, face, and neck C83.32 Diffuse large B-cell lymphoma, intrathoracic lymph nodes C83.33 Diffuse large B-cell lymphoma, intra-abdominal lymph nodes C83.34 Diffuse large B -cell lymphoma, lymph nodes of axilla and upper limb C83.35 Diffuse large B -cell lymphoma, lymph nodes of inguinal region and lower limb C83.36 Diffuse large B-cell lymphoma, intrapelvic lymph nodes C83.37 Diffuse large B-cell lymphoma, spleen C83.38 Diffuse large B-cell lymphoma, lymph nodes of multiple sites C83.39 Diffuse large B-cell lymphoma, extranodal and solid organ sites C83.51 Lymphoblastic (diffuse) lymphoma, lymph nodes of head, face, and neck C83.52 Lymphoblastic (diffuse) lymphoma, intrathoracic lymph nodes C83.53 Lymphoblastic (diffuse) lymphoma, intra-abdominal lymph nodes C83.54 Lymphoblastic (diffuse) lymphoma, lymph nodes of axilla and upper limb C83.55 Lymphoblastic (diffuse) lymphoma, lymph nodes of inguinal region and lower limb C83.56 Lymphoblastic (diffuse) lymphoma, intrapelvic lymph nodes C83.57 Lymphoblastic (diffuse) lymphoma, spleen C83.58 Lymphoblastic (diffuse) lymphoma, lymph nodes of multiple sites C83.59 Lymphoblastic (diffuse) lymphoma, extranodal and solid organ sites C83.71 Burkitt lymphoma, lymph nodes of head, face, and neck C83.72 Burkitt lymphoma, intrathoracic lymph nodes C83.73 Burkitt lymphoma, intra-abdominal lymph nodes C83.74 Burkitt lymphoma, lymph nodes of axilla and upper limb C83.75 Burkitt lymphoma, lymph nodes of inguinal region and lower limb C83.76 Burkitt lymphoma, intrapelvic lymph nodes C83.77 Burkitt lymphoma, spleen C83.78 Burkitt lymphoma, lymph nodes of multiple sites C83.79 Burkitt lymphoma, extranodal and solid organ sites C83.81 Other non-follicular lymphoma, lymph nodes of head, face, and neck C83.82 Other non-follicular lymphoma, intrathoracic lymph nodes C83.83 Other non-follicular lymphoma, intra-abdominal lymph nodes C83.84 Other non -follicular lymphoma, lymph nodes of axilla and upper limb C83.85 Other non -follicular lymphoma, lymph nodes of inguinal region and lower limb C83.86 Other non-follicular lymphoma, intrapelvic lymph nodes C83.87 Other non-follicular lymphoma, spleen C83.88 Other non-follicular lymphoma, lymph nodes of multiple sites C83.89 Other non-follicular lymphoma, extranodal and solid organ sites C83.91 Non-follicular (diffuse) lymphoma, unspecified, lymph nodes of head, face, and neck C83.92 Non-follicular (diffuse) lymphoma, unspecified, intrathoracic lymph nodes C83.93 Non-follicular (diffuse) lymphoma, unspecified, intra-abdominal lymph nodes C83.94 Non-follicular (diffuse) lymphoma, unspecified, lymph nodes of axilla and upper limb C83.95 Non-follicular (diffuse) lymphoma, unspecified, lymph nodes of inguinal region and lower limb C83.96 Non-follicular (diffuse) lymphoma, unspecified, intrapelvic lymph nodes C83.97 Non-follicular (diffuse) lymphoma, unspecified, spleen C83.98 Non-follicular (diffuse) lymphoma, unspecified, lymph nodes of multiple sites C83.99 Non-follicular (diffuse) lymphoma, unspecified, extranodal and solid organ sites C84.01 Mycosis fungoides, lymph nodes of head, face, and neck C84.02 Mycosis fungoides, intrathoracic lymph nodes C84.03 Mycosis fungoides, intra-abdominal lymph nodes C84.04 Mycosis fungoides, lymph nodes of axilla and upper limb C84.05 Mycosis fungoides, lymph nodes of inguinal region and lower limb C84.06 Mycosis fungoides, intrapelvic lymph nodes C84.07 Mycosis fungoides, spleen C84.08 Mycosis fungoides, lymph nodes of multiple sites C84.09 Mycosis fungoides, extranodal and solid organ sites C84.11 Sezary disease, lymph nodes of head, face, and neck C84.12 Sezary disease, intrathoracic lymph nodes C84.13 Sezary disease, intra-abdominal lymph nodes

(Medicare Claims Processing Manual)

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lymphoma, unspecified, extranodal and solid organ sites C84.01 Mycosis fungoides, lymph nodes of head, face, and neck C84.02 Mycosis fungoides, intrathoracic lymph nodes C84.03 Mycosis fungoides, intra-abdominal lymph nodes C84.04 Mycosis fungoides, lymph nodes of axilla and upper limb C84.05 Mycosis fungoides, lymph nodes of inguinal region and lower limb C84.06 Mycosis fungoides, intrapelvic lymph nodes C84.07 Mycosis fungoides, spleen C84.08 Mycosis fungoides, lymph nodes of multiple sites C84.09 Mycosis fungoides, extranodal and solid organ sites C84.11 Sezary disease, lymph nodes of head, face, and neck C84.12 Sezary disease, intrathoracic lymph nodes C84.13 Sezary disease, intra-abdominal lymph nodes C84.14 Sezary disease, lymph nodes of axilla and upper limb C84.15 Sezary disease, lymph nodes of inguinal region and lower limb C84.16 Sezary disease, intrapelvic lymph nodes C84.17 Sezary disease, spleen C84.18 Sezary disease, lymph nodes of multiple sites C84.19 Sezary disease, extranodal and solid organ sites C84.41 Peripheral T-cell lymphoma, not classified, lymph nodes of head, face, and neck C84.42 Peripheral T-cell lymphoma, not classified, intrathoracic lymph nodes C84.43 Peripheral T -cell lymphoma, not classified, intra -abdominal lymph nodes C84.44 Peripheral T -cell lymphoma, not classified, lymph nodes of axilla and upper limb C84.45 Peripheral T -cell lymphoma, not classified, lymph nodes of inguinal region and lower limb C84.46 Peripheral T-cell lymphoma, not classified, intrapelvic lymph nodes C84.47 Peripheral T-cell lymphoma, not classified, spleen C84.48 Peripheral T -cell lymphoma, not classified, lymph nodes of multiple sites C84.49 Peripheral T -cell lymphoma, not classified, extranodal and solid organ sites C84.61 Anaplastic large cell lymphoma, ALK -positive, lymph nodes of head, face, and neck C84.62 Anaplastic large cell lymphoma, ALK -positive, intrathoracic lymph nodes C84.63 Anaplastic large cell lymphoma, ALK -positive, intra -abdominal lymph nodes C84.64 Anaplastic large cell lymphoma, ALK -positive, lymph nodes of axilla and upper limb C84.65 Anaplastic large cell lymphoma, ALK -positive, lymph nodes of inguinal region and lower limb C84.66 Anaplastic large cell lymphoma, ALK -positive, intrapelvic lymph nodes C84.67 Anaplastic large cell lymphoma, ALK -positive, spleen C84.68 Anaplastic large cell lymphoma, ALK -positive, lymph nodes of multiple sites C84.69 Anaplastic large cell lymphoma, ALK -positive, extranodal and solid organ sites C84.71 Anaplastic large cell lymphoma, ALK -negative, lymph nodes of head, face, and neck C84.72 Anaplastic large cell lymphoma, ALK -negative, intrathoracic lymph nodes C84.73 Anaplastic large cell lymphoma, ALK -negative, intra -abdominal lymph nodes C84.74 Anaplastic large cell lymphoma, ALK -negative, lymph nodes of axilla and upper limb C84.75 Anaplastic large cell lymphoma, ALK -negative, lymph nodes of inguinal region and lower limb C84.76 Anaplastic large cell lymphoma, ALK -negative, intrapelvic lymph nodes C84.77 Anaplastic large cell lymphoma, ALK -negative, spleen C84.78 Anaplastic large cell lymphoma, ALK -negative, lymph nodes of multiple sites C84.79 Anaplastic large cell lymphoma, ALK -negative, extranodal and solid organ sites C84.91 Mature T/NK -cell lymphomas, unspecified, lymph nodes of head, face, and neck C84.92 Mature T/NK -cell lymphomas, unspecified, intrathoracic lymph nodes C84.93 Mature T/NK -cell lymphomas, unspecified, intra-abdominal lymph nodes C84.94 Mature T/NK -cell lymphomas, unspecified, lymph nodes of axilla and upper limb C84.95 Mature T/NK -cell lymphomas, unspecified, lymph nodes of inguinal region and lower limb C84.96 Mature T/NK -cell lymphomas, unspecified, intrapelvic lymph nodes C84.97 Mature T/NK -cell lymphomas, unspecified, spleen C84.98 Mature T/NK -cell lymphomas, unspecified, lymph nodes of multiple sites C84.99 Mature T/NK -cell lymphomas, unspecified, extranodal and solid organ sites C84.A1 Cutaneous T-cell lymphoma, unspecified lymph nodes of head, face, and neck C84.A2 Cutaneous T-cell lymphoma, unspecified, intrathoracic lymph nodes C84.A3 Cutaneous T-cell lymphoma, unspecified, intra-abdominal lymph nodes C84.A4 Cutaneous T-cell lymphoma, unspecified, lymph nodes of axilla and upper limb C84.A5 Cutaneous T-cell lymphoma, unspecified, lymph nodes of inguinal region and lower limb C84.A6 Cutaneous T-cell lymphoma, unspecified, intrapelvic lymph nodes C84.A7 Cutaneous T-cell lymphoma, unspecified, spleen C84.A8 Cutaneous T-cell lymphoma, unspecified, lymph nodes of multiple sites C84.A9 Cutaneous T -cell lymphoma, unspecified, extranodal and solid organ sites C84.Z1 Other mature T/NK -cell lymphomas, lymph nodes of head, face, and neck C84.Z2 Other mature T/NK -cell lymphomas, intrathoracic lymph nodes C84.Z3 Other mature T/NK -cell lymphomas, intra -abdominal lymph nodes C84.Z4 Other mature T/NK -cell lymphomas, lymph nodes of axilla and upper limb C84.Z5 Other mature T/NK -cell lymphomas, lymph nodes of inguinal region and lower limb C84.Z6 Other mature T/NK -cell lymphomas, intrapelvic lymph nodes C84.Z7 Other mature T/NK -cell lymphomas, spleen C84.Z8 Other mature T/NK -cell lymphomas, lymph nodes of multiple sites C84.Z9 Other mature T/NK -cell lymphomas, extranodal and solid organ sites C85.11 Unspecified B-cell lymphoma, lymph nodes of head, face, and neck C85.12 Unspecified B-cell lymphoma, intrathoracic lymph nodes C85.13 Unspecified B-cell lymphoma, intra-abdominal lymph nodes C85.14 Unspecified B -cell lymphoma, lymph nodes of axilla and upper limb C85.15 Unspecified B -cell lymphoma, lymph nodes of inguinal region and lower limb C85.16 Unspecified B-cell lymphoma, intrapelvic lymph nodes C85.17 Unspecified B-cell lymphoma, spleen C85.18 Unspecified B-cell lymphoma, lymph nodes of multiple sites C85.19 Unspecified B-cell lymphoma, extranodal and solid organ sites C85.21 Mediastinal (thymic) large B -cell lymphoma, lymph nodes of head, face, and neck C85.22 Mediastinal (thymic) large B-cell lymphoma, intrathoracic lymph nodes C85.23 Mediastinal (thymic) large B -cell lymphoma, intra -abdominal lymph nodes C85.24 Mediastinal (thymic) large B -cell lymphoma, lymph nodes of axilla and upper limb C85.25 Mediastinal (thymic) large B -cell lymphoma, lymph nodes of inguinal region and lower limb C85.26 Mediastinal (thymic) large B-cell lymphoma, intrapelvic lymph nodes C85.27 Mediastinal (thymic) large B-cell lymphoma, spleen C85.28 Mediastinal (thymic) large B -cell lymphoma, lymph nodes of multiple sites C85.29 Mediastinal (thymic) large B -cell lymphoma, extranodal and solid organ sites C85.81 Other specified types of non-Hodgkin lymphoma, lymph nodes of head, face, and neck C85.82 Other specified types of non -Hodgkin lymphoma, intrathoracic lymph nodes C85.83 Other specified types of non-Hodgkin lymphoma, intra - abdominal lymph nodes C85.84 Other specified types of non-Hodgkin lymphoma, lymph nodes of axilla and upper limb C85.85 Other specified types of non-Hodgkin lymphoma, lymph nodes of inguinal region and lower limb C85.86 Other specified types of non -Hodgkin lymphoma, intrapelvic lymph nodes C85.87 Other specified types of non-Hodgkin lymphoma, spleen C85.88 Other specified types of non-Hodgkin lymphoma, lymph nodes of multiple sites C85.89 Other specified types of non -Hodgkin lymphoma, extranodal and solid organ sites C85.91 Non-Hodgkin lymphoma, unspecified, lymph nodes of head, face, and neck C85.92 Non-Hodgkin lymphoma, unspecified, intrathoracic lymph nodes C85.93 Non-Hodgkin lymphoma, unspecified, intra-abdominal lymph nodes C85.94 Non-Hodgkin lymphoma, unspecified, lymph nodes of axilla and upper limb C85.95 Non-Hodgkin lymphoma, unspecified, lymph nodes of inguinal region and lower limb C85.96 Non-Hodgkin lymphoma, unspecified, intrapelvic lymph nodes C85.97 Non-Hodgkin lymphoma, unspecified, spleen C85.98 Non-Hodgkin lymphoma, unspecified, lymph nodes of multiple sites C85.99 Non-Hodgkin lymphoma,

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lymphoma, spleen C85.88 Other specified types of non-Hodgkin lymphoma, lymph nodes of multiple sites C85.89 Other specified types of non -Hodgkin lymphoma, extranodal and solid organ sites C85.91 Non-Hodgkin lymphoma, unspecified, lymph nodes of head, face, and neck C85.92 Non-Hodgkin lymphoma, unspecified, intrathoracic lymph nodes C85.93 Non-Hodgkin lymphoma, unspecified, intra-abdominal lymph nodes C85.94 Non-Hodgkin lymphoma, unspecified, lymph nodes of axilla and upper limb C85.95 Non-Hodgkin lymphoma, unspecified, lymph nodes of inguinal region and lower limb C85.96 Non-Hodgkin lymphoma, unspecified, intrapelvic lymph nodes C85.97 Non-Hodgkin lymphoma, unspecified, spleen C85.98 Non-Hodgkin lymphoma, unspecified, lymph nodes of multiple sites C85.99 Non-Hodgkin lymphoma, unspecified, extranodal and solid organ sites C86.0 Extranodal NK/T -cell lymphoma, nasal type C86.1 Hepatosplenic T-cell lymphoma C86.2 Enteropathy -type (intestinal) T-cell lymphoma C86.3 Subcutaneous panniculitis -like T-cell lymphoma C86.4 Blastic NK-cell lymphoma C86.5 Angioimmunoblastic T-cell lymphoma C86.6 Primary cutaneous CD30 -positive T-cell proliferations C88.0 Waldenstrom macroglobulinemia C88.2 Heavy chain disease C88.3 Immunoproliferative small intestinal disease C88.4 Extranodal marginal zone B -cell lymphoma of mucosa - associated lymphoid tissue [MALT -lymphoma] C88.8 Other malignant immunoproliferative diseases C88.9 Malignant immunoproliferative disease, unspecified C90.00 Multiple myeloma not having achieved remission C90.01 Multiple myeloma in remission C90.02 Multiple myeloma in relapse C90.10 Plasma cell leukemia not having achieved remission C90.11 Plasma cell leukemia in remission C90.20 Extramedullary plasmacytoma not having achieved remission C90.21 Extramedullary plasmacytoma in remission C90.22 Extramedullary plasmacytoma in relapse C90.30 Solitary plasmacytoma not having achieved remission C90.31 Solitary plasmacytoma in remission C90.32 Solitary plasmacytoma in relapse C91.01 Acute lymphoblastic leukemia, in remission C91.11 Chronic lymphocytic leukemia of B-cell type in remission C91.31 Prolymphocytic leukemia of B-cell type, in remission C91.51 Adult T-cell lymphoma/leukemia (HTLV -1-associated), in remission C91.61 Prolymphocytic leukemia of T-cell type, in remission C91.91 Lymphoid leukemia, unspecified, in remission C91.A1 Mature B-cell leukemia Burkitt -type, in remission C91.Z1 Other lymphoid leukemia, in remission C92.01 Acute myeloblastic leukemia, in remission C92.11 Chronic myeloid leukemia, BCR/ABL -positive, in remission C92.21 Atypical chronic myeloid leukemia, BCR/ABL -negative, in remission C92.31 Myeloid sarcoma, in remission C92.41 Acute promyelocytic leukemia, in remission C92.51 Acute myelomonocytic leukemia, in remission C92.61 Acute myeloid leukemia with 11q23 -abnormality in remission C92.91 Myeloid leukemia, unspecified in remission C92.A1 Acute myeloid leukemia with multilineage dysplasia, in remission C92.Z1 Other myeloid leukemia, in remission C93.01 Acute monoblastic/monocytic leukemia, in remission C93.11 Chronic myelomonocytic leukemia, in remission C93.31 Juvenile myelomonocytic leukemia, in remission C93.91 Monocytic leukemia, unspecified in remission C93.Z1 Other monocytic leukemia, in remission C94.01 Acute erythroid leukemia, in remission C94.21 Acute megakaryoblastic leukemia, in remission C94.31 Mast cell leukemia, in remission C94.81 Other specified leukemias, in remission C95.01 Acute leukemia of unspecified cell type, in remission C95.11 Chronic leukemia of unspecified cell type, in remission C95.91 Leukemia, unspecified, in remission C96.0 Multifocal and multisystemic (disseminated) Langerhans -cell histiocytosis C96.20 Malignant mast cell neoplasm, unspecified C96.21 Aggressive systemic mastocytosis C96.22 Mast cell sarcoma C96.29 Other malignant mast cell neoplasm C96.4 Sarcoma of dendritic cells (accessory cells) C96.5 Multifocal and unisystemic Langerhans -cell histiocytosis C96.6 Unifocal Langerhans -cell histiocytosis C96.9 Malignant neoplasm of lymphoid, hematopoietic and related tissue, unspecified C96.A Histiocytic sarcoma C96.Z Other specified malignant neoplasms of lymphoid, hematopoietic and related tissue D45 Polycythemia vera D47.Z9 Other specified neoplasms of uncertain behavior of lymphoid, hematopoietic and related tissue E85.4 Organ -limited amyloidosis E85.81 Light chain (AL) amyloidosis E85.89 Other amyloidosis E85.9 Amyloidosis, unspecified

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clm104c32.pdf

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a. Effective for services performed on or after April 28, 1989: Acute leukemia in remission who have a high probability of relapse and who have no human leucocyte antigens (HLA)- matched (ICD -10-CM diagnosis codes C91.01, C92.01, C92,41, C92.51, C92.61, C92.A1, C93.01, C94.01, C94.21, C94.41, C95.01); Resistant non- Hodgkin's lymphomas or those presenting with poor prognostic features following an initial response (ICD - 10-CM diagnosis codes C82.01- C85.29, C85.81- C86.6, C96.4, and C96.Z -C96.9); Recurrent or refractory neuroblastoma (see ICD -10-CM codes Neoplasm by site, malignant for the appropriate diagnosis code) following ranges are reported: C00 - C96, and D00 - D09 Resistant non- Hodgkins lymphomas); or, Advanced Hodgkin's disease who have failed conventional therapy and have no HLA -matched donor (ICD -10-CM codes C81.01 - C81.99). a. Effective for services performed on or after October 1, 2000: Single AuSCT is only covered for Durie -Salmon Stage II or III multiple myeloma patients (ICD -10-CM codes C90.00, C90.01, C90.02 and D47.Z9) that fit the following requirements: Newly diagnosed or responsive multiple myeloma. This includes those patients with previously untreated disease, those with at least a partial response to prior chemotherapy (defined as a 50% decrease either in measurable paraprotein [serum and/or urine] or in bone marrow infiltration, sustained for at least 1 month), and those in responsive relapse; and Adequate cardiac, renal, pulmonary, and hepatic function. b. Effective for services performed on or after March 15, 2005: When recognized clinical risk factors are employed to select patients for transplantation, high dose melphalan (HDM) together with AuSCT is reasonable and necessary for Medicare beneficiaries of any age group with primary amyloid light chain (AL) amyloidosis (ICD -10-CM codes E85.4, E85.81, E85.89 and E85.9) who meet the following criteria: Amyloid deposition in 2 or fewer organs; and, Cardiac left ventricular ejection fraction (EF) greater than 45%. E85.4 Organ- limited amyloidosis E85.81 Light chain (AL) amyloidosis E85.89 Other amyloidosis E85.9 Amyloidosis, unspecified As the applicable ICD -10 CM codes E85.4, E85.81, E85.9, and E85.89 for amyloidosis do not differentiate between primary and non- primary, A/B MACs (B) should perform prepay reviews on all claims with a diagnosis of ICD - 10-CM code E85.4, E85.81, E85.9, and E85.89 to determine whether payment is appropriate. C. Nationally Non-Covered Indications I. Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) Effective for claims with dates of service on or after May 24, 1996, through January 27, 2016, allogeneic HSCT is not covered as treatment for multiple myeloma (if ICD-10-CM is applicable, ICD- 10-CM codes C90.00, C90.01, C90.02 and D47.Z9). II. Autologous Stem Cell Transplantation (AuSCT) AuSCT is not considered reasonable and necessary within the meaning of l862(a)(1)(A) of the Act and is not covered under Medicare for the following conditions: Acute leukemia not in remission prior to October 1, 2000 ( if ICD-10-CM is applicable, ICD -10-CM codes C91.00, C92.00, C93.00, C94.00, and C95.00) Chronic granulocytic leukemia prior to October 1, 2000 (if ICD-10-CM is applicable, ICD -10-CM code C92.10); 1.Solid tumors prior to October 1, 2000 (other than neuroblastoma) (if ICD -10-CM is applicable, ICD -10- CM codes C00.0 C80.2 and D00.0 D09.9); 2. Multiple myeloma prior to October 1, 2000 (if ICD -10-CM is applicable, ICD -10-CM codes C90.00, C90.01, C90.02 and D47.Z9); 3. Tandem transplantation, on or after October 1, 2000 (if ICD-10-CM is applicable, ICD -10-CM codes C90.00, C90.01, C90.02, and D47.Z9) ; 4. Non- primary amyloidosis on or after 10/01/00, for all Medicare beneficiaries 5. Primary AL amyloidosis effective October 1, 2000, through March 14, 2005 for Medicare beneficiaries age 64. (if ICD -10-CM is applicable, ICD -10-CM codes E85.4, E85.81, E85.9, and E85.89); As the ICD -10-CM is applicable, as the applicable ICD -10 CM codes E85.4, E85.81, E85.9, and E85.89 for amyloidosis do not differentiate between primary and non- primary, A/B MACs (B) should perform prepay reviews on all claims with a diagnosis of ICD -10-CM code E85.4, E85.81, E85.9, and E85.89 to determine whether payment is appropriate. 2. Other All other indications for stem cell transplantation not otherwise noted above as covered or non- covered remain at local Medicare Administrative Contractor discretion. 3. Suggested MSN and RA Messages The contractor shall use an appropriate MSN and CARC message such as the following: MSN - 15.4, The information provided does not support the need for this service or item; CARC - 150, Payment adjusted because the payer deems the information submitted does not support this level of service. 4. Clinical Trials for Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for Myelodysplastic Syndrome (MDS), Multiple Myeloma, Myelofibrosis (MF), and for Sickle Cell Disease (SCD) Background Effective for services performed on or after August 4, 2010, contractors shall pay for claims for allogeneic HSCT for the treatment of Myelodysplastic Syndromes (MDS) pursuant to Coverage with Evidence Development (CED) in the context of a Medicare- approved, prospective clinical study. Effective for services performed on or after January 27, 2016, contractors shall pay for claims for allogeneic HSCT for the treatment of multiple myeloma, myelofibrosis (MF), and for sickle cell disease (SCD) pursuant to CED, in the context of a Medicare -approved, prospective clinical study. Refer to Pub.100- 03, National Coverage Determinations Manual, Chapter 1, section 110.23, for more information about this policy, and Pub. 100 -04, Medicare Claims Processing Manual, Chapter 3, section 90.3, for information on inpatient billing of this CED. Adjudication Requirements Payable Conditions. For claims with dates of service on and after August 4, 2010, contractors shall pay for claims for allogeneic HSCT for MDS when the service was provided pursuant to a Medicare- approved clinical study under CED; these services are paid only in the inpatient setting (Type of Bill (TOB) 11X), as outpatient Part B (TOB 13X), and in Method II critical access hospitals (TOB 85X). Contractors shall require the following coding in order to pay for these claims: Existing Medicare -approved clinical trial coding conventions, as required in Pub. 100- 04, Medicare Claims Processing Manual, Chapter 32, section 69, and inpatient billing requirements regarding acquisition of stem cells in Pub. 100- 04, Medicare Claims Processing Manual, Chapter 3, section 90.3.1. If ICD -10-CM is applicable, ICD -10-PCS, procedure codes 30230G2, 30230G3, 30230Y2, 30230Y3, 30233G2, 30233G3, 30233Y2, 30233Y3, 30240G2, 30240G3, 30240Y2, 30240Y3, 30243G2, 30243G3, 30243Y2, and 30243Y3. If Outpatient Hospital or Professional Claims: HCPCS procedure code 38240 If ICD -10-CM is applicable, ICD -10-CM codes D46.A, D46.B, D46.C, D46.Z, D46.0, D46.1, D46.4, D46.9, D46.20, D46.21, D46.22, and Z00.6. Professional claims only: place of service codes 19, 21, or 22. Payable Conditions. For claims with dates of service on and after January 27, 2016, contractors shall pay for claims for allogeneic HSCT for multiple myeloma, myelofibrosis (MF), and for sickle cell disease (SCD) when the service was provided pursuant to a Medicare -approved clinical study under CED; these services are paid only in the inpatient setting (Type of Bill (TOB) 11X), as outpatient Part B (TOB 13X), and in Method II critical access hospitals (TOB 85X). Contractors shall require the following coding in order to pay for these claims: Existing Medicare -approved clinical trial coding conventions, as required in Pub. 100- 04, Medicare Claims Processing Manual, Chapter 32, section 69, and inpatient billing requirements regarding acquisition of stem cells in Pub. 100- 04, Medicare Claims Processing Manual, Chapter 3, section 90.3.1. ICD-10-PCS codes 30230G2, 30230G3, 30230Y2, 30230Y3, 30233G2, 30233G3, 30233Y2, 30233Y3, 30240G2, 30240G3, 30240Y2, 30240Y3, 30243G2, 30243G3, 30243Y2, and 30243Y3.

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Contractors shall require the following coding in order to pay for these claims: Existing Medicare -approved clinical trial coding conventions, as required in Pub. 100- 04, Medicare Claims Processing Manual, Chapter 32, section 69, and inpatient billing requirements regarding acquisition of stem cells in Pub. 100- 04, Medicare Claims Processing Manual, Chapter 3, section 90.3.1. ICD-10-PCS codes 30230G2, 30230G3, 30230Y2, 30230Y3, 30233G2, 30233G3, 30233Y2, 30233Y3, 30240G2, 30240G3, 30240Y2, 30240Y3, 30243G2, 30243G3, 30243Y2, and 30243Y3. ICD-10-CM diagnosis codes C90.00, C90.01, C90.02, C94.40, C94.41, C94.42, D47.1, D47.4, D75.81, D57.00, D57.01, D57.02, D57.03, D57.09, D57.1, D57.20, D57.211, D57.212, D57.213, D57.218, D57.219, D57.40, D57.411, D57.412, D57.413, D57.418, D57.419, D57.42, D57.431, D57.432, D57.433, D57.438, D57.439, D57.44, D57.451, D57.452, D57.453, D57.458, and D57.459, D57.80, D57.811, D57.812, D57.813, D57.818, D57.819, and Z00.6. If Outpatient Hospital or Professional Claims: HCPCS procedure code 38240 Professional claims only: place of service codes 19, 21, or 22. Denials. Contractors shall deny claims failing to meet any of the above criteria. In addition, contractors shall apply the following requirements: Providers shall issue a hospital issued notice of non- coverage (HINN) or advance beneficiary notice (ABN) to the beneficiary if the services performed are not provided in accordance with CED. Contractors shall deny claims that do not meet the criteria for coverage with the following messages: CARC 50 - These are non -covered services because this is not deemed a 'medical necessity' by the payer. NOTE: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. 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 a http:www.cms.hhs.gov/mcd/search.asp. If you do not have web access, you may contact the contractor to request a copy of the NCD. Group Code Patient Responsibility (PR) if HINN/ABN issued, otherwise Contractual Obligation (CO) MSN 16.77 This service/item was not covered because it was not provided as part of a qualifying trial/study. (Este servicio/artculo no fue cubierto porque no estaba incluido como parte de un ensayo clnico/estudio calificado.) MSN 15.20 The following policies [NCD 110.23] were used when we made this decision. (Las siguientes polticas [NCD 110.23] fueron utilizadas cuando se tom esta decisin.) 90.1 - General (Rev. 486, Issued: 03- 04-05, Effective Date/Implementation Date: N/A) Allogeneic Stem Cell Transplantation. Allogeneic stem cell transplantation is a procedure in which a portion of a healthy donors stem cells is obtained and prepared for intravenous infusion to restore normal hematopoietic function in recipients having an inherited or acquired hematopoietic de ficiency or defect. Expenses incurred by a donor are a covered benefit to the recipient/beneficiary but, except for physician services, are not paid separately. Services to the donor include physician services, hospital care in connection with screening the stem cell, and ordinary follow -up care. Autologous Stem Cell Transplantation Autologous stem cell transplantations is a technique for restoring stem cells using the patients own previously stored cells. Autologous stem cell transplants are covered for certain specified diagnoses for services rendered on or after April 28, 1989. 90.2 - HCPCS and Diagnosis Coding ICD-9-CM Applicable (Rev.11035, Issued:10 -13-21, Effective: 11-17-21; Implementation: 11-21) Allogeneic Stem Cell Transplantation Effective for services performed on or after August 1, 1978:For the treatment of leukemia or leukemia in remission, providers shall use appropriate ICD -10 diagnosis codes noted in section 90 and HCPCS code 38240. For the treatment of aplastic anemia, providers shall use appropriate ICD -10 diagnosis codes noted in section 90 and HCPCS code 38240. Effective for services performed on or after June 3, 1985: For the treatment of severe combined immunodeficiency disease, providers shall use appropriate ICD -10 diagnosis codes noted in section 90 and HCPCS code 38240. For the treatment of Wiskott- Aldrich syndrome, providers shall use appropriate ICD -10-CM code D82.0 and HCPCS code 38240. Autologous Stem Cell Transplantation .--Is covered under the following circumstances effective for services performed on or after April 28, 1989: For the treatment of patients with acute leukemia in remission who have a high probability of relapse and who have no human leucocyte antigens (HLA) matched, providers shall use appropriate ICD -10 diagnosis codes noted in section 90 for lymphoid; myeloid; monocytic; acute erythremia; erythroleukemia; unspecified cell type and HCPCS code 38241. For the treatment of resistant non- Hodgkins lymphomas for those patients presenting with poor prognostic features following an initial response, providers shall use appropriate ICD -10 diagnosis codes noted in section 90 and HCPCS code 38241. For the treatment of recurrent or refractory neuroblastoma, providers shall use ICD - 10-CM codes Neoplasm by site, malignant, the appropriate HCPCS code and HCPCS code 38241. For the treatment of advanced Hodgkins disease for patients who have failed conventional therapy and have no HLA -matched donor, providers shall use appropriate ICD -10 diagnosis codes and HCPCS code 38241 Autologous Stem Cell Transplantation .--Is covered under the following circumstances effective for services furnished on or after October 1, 2000: For the treatment of multiple myeloma (only for beneficiaries who are less than age 78, have Durie-Salmon stage II or III newly diagnosed or responsive multiple myeloma, and have adequate cardiac, renal, pulmonary and hepatic functioning), providers shall use appropriate ICD-10- CM code and HCPCS code 38241. For the treatment of recurrent or refractory neuroblastoma, providers shall use appropriate code (see ICD-10-CM neoplasm by site, malignant) and HCPCS code 38241. Effective for services performed on or after March 15, 2005, when recognized clinical risk factors are employed to select patients for transplantation, high-dose melphalan (HDM) together with autologous stem cell transplantation (HDM/AuSCT) is reasonable and necessary for Medicare beneficiaries of any age group for the treatment of primary amyloid light chain (AL) amyloidosis, ICD-10- CM codes E85.4, E85.81, E85.9, and E85.89 who meet the following criteria: Amyloid deposition in 2 or fewer organs; and, Cardiac left ventricular ejection fraction (EF) greater than 45%. 90.2.1 - HCPCS and Diagnosis Coding for Stem Cell Transplantation - ICD-10-CM Applicable (Rev. 11035, Issued:10 -13-21, Effective: 11-17-21; Implementation: 11-17-21) ICD-10 is applicable to services on and after the implementation of ICD-. For services provided use the appropriate code from the ICD -10 CM codes the table below.. See 90.2 for a list of covered conditions

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Effective for services performed on or after March 15, 2005, when recognized clinical risk factors are employed to select patients for transplantation, high-dose melphalan (HDM) together with autologous stem cell transplantation (HDM/AuSCT) is reasonable and necessary for Medicare beneficiaries of any age group for the treatment of primary amyloid light chain (AL) amyloidosis, ICD-10- CM codes E85.4, E85.81, E85.9, and E85.89 who meet the following criteria: Amyloid deposition in 2 or fewer organs; and, Cardiac left ventricular ejection fraction (EF) greater than 45%. 90.2.1 - HCPCS and Diagnosis Coding for Stem Cell Transplantation - ICD-10-CM Applicable (Rev. 11035, Issued:10 -13-21, Effective: 11-17-21; Implementation: 11-17-21) ICD-10 is applicable to services on and after the implementation of ICD-. For services provided use the appropriate code from the ICD -10 CM codes the table below.. See 90.2 for a list of covered conditions ICD-10 Description C91.00 Acute lymphoblastic leukemia not having achieved remission C91.01 Acute lymphoblastic leukemia, in remission C91.02 Acute lymphoblastic leukemia, in relapse C91.10 Chronic lymphocytic leukemia of B-cell type not having achieved remission C91.11 Chronic lymphocytic leukemia of B-cell type in remission C91.12 Chronic lymphocytic leukemia of B-cell type in relapse C91.30 Prolymphocytic leukemia of B-cell type not having achieved remission C91.31 Prolymphocytic leukemia of B-cell type, in remission C91.32 Prolymphocytic leukemia of B-cell type, in relapse C91.50 Adult T-cell lymphoma/leukemia (HTLV -1-associated) not having achieved remission C91.51 Adult T-cell lymphoma/leukemia (HTLV -1-associated), in remission C91.52 Adult T-cell lymphoma/leukemia (HTLV -1-associated), in relapse C91.60 Prolymphocytic leukemia of T-cell type not having achieved remission C91.61 Prolymphocytic leukemia of T-cell type, in remission C91.62 Prolymphocytic leukemia of T-cell type, in relapse C91.90 Lymphoid leukemia, unspecified not having achieved remission C91.91 Lymphoid leukemia, unspecified, in remission C91.92 Lymphoid leukemia, unspecified, in relapse C91.A0 Mature B-cell leukemia Burkitt -type not having achieved remission C91.A1 Mature B-cell leukemia Burkitt -type, in remission C91.A2 Mature B-cell leukemia Burkitt -type, in relapse C91.Z0 Other lymphoid leukemia not having achieved remission C91.Z1 Other lymphoid leukemia, in remission C91.Z2 Other lymphoid leukemia, in relapse C92.00 Acute myeloblastic leukemia, not having achieved remission C92.01 Acute myeloblastic leukemia, in remission C92.02 Acute myeloblastic leukemia, in relapse C92.10 Chronic myeloid leukemia, BCR/ABL -positive, not having achieved remission C92.11 Chronic myeloid leukemia, BCR/ABL -positive, in remission C92.12 Chronic myeloid leukemia, BCR/ABL -positive, in relapse C92.20 Atypical chronic myeloid leukemia, BCR/ABL -negative, not having achieved remission C92.21 Atypical chronic myeloid leukemia, BCR/ABL -negative, in remission C92.22 Atypical chronic myeloid leukemia, BCR/ABL -negative, in relapse C92.30 Myeloid sarcoma, not having achieved remission C92.31 Myeloid sarcoma, in remission C92.32 Myeloid sarcoma, in relapse C92.40 Acute promyelocytic leukemia, not having achieved remission C92.41 Acute promyelocytic leukemia, in remission C92.42 Acute promyelocytic leukemia, in relapse C92.50 Acute myelomonocytic leukemia, not having achieved remission C92.51 Acute myelomonocytic leukemia, in remission C92.52 Acute myelomonocytic leukemia, in relapse C92.60 Acute myeloid leukemia with 11q23 -abnormality not having achieved remission C92.61 Acute myeloid leukemia with 11q23 -abnormality in remission C92.62 Acute myeloid leukemia with 11q23 -abnormality in relapse C92.90 Myeloid leukemia, unspecified, not having achieved remission C92.91 Myeloid leukemia, unspecified in remission C92.92 Myeloid leukemia, unspecified in relapse C92.A0 Acute myeloid leukemia with multilineage dysplasia, not having achieved remission C92.A1 Acute myeloid leukemia with multilineage dysplasia, in remission C92 A2 At l id lk i ith ltili d li i l C92.Z0 Other myeloid leukemia not having achieved remission C92.Z1 Other myeloid leukemia, in remission C92.Z2 Other myeloid leukemia, in relapse C93.00 Acute monoblastic/monocytic leukemia, not having achieved remission C93.01 Acute monoblastic/monocytic leukemia, in remission C93.02 Acute monoblastic/monocytic leukemia, in relapse C93.10 Chronic myelomonocytic leukemia not having achieved remission C93.11 Chronic myelomonocytic leukemia, in remission C93.12 Chronic myelomonocytic leukemia, in relapse C93.30 Juvenile myelomonocytic leukemia, not having achieved remission C93.31 Juvenile myelomonocytic leukemia, in remission C93.32 Juvenile myelomonocytic leukemia, in relapse C93.90 Monocytic leukemia, unspecified, not having achieved remission C93.91 Monocytic leukemia, unspecified in remission C93.92 Monocytic leukemia, unspecified in relapse C93.Z0 Other monocytic leukemia, not having achieved remission C93.Z1 Other monocytic leukemia, in remission C93.Z2 Other monocytic leukemia, in relapse C94.00 Acute erythroid leukemia, not having achieved remission C94.01 Acute erythroid leukemia, in remission C94.02 Acute erythroid leukemia, in relapse C94.20 Acute megakaryoblastic leukemia not having achieved remission C94.21 Acute megakaryoblastic leukemia, in remission C94.22 Acute megakaryoblastic leukemia, in relapse C94.30 Mast cell leukemia not having achieved remission C94.31 Mast cell leukemia, in remission C94.32 Mast cell leukemia, in relapse C94.80 Other specified leukemias not having achieved remission C94.81 Other specified leukemias, in remission C94.82 Other specified leukemias, in relapse C95.00 Acute leukemia of unspecified cell type not having achieved remission C95.01 Acute leukemia of unspecified cell type, in remission C95.02 Acute leukemia of unspecified cell type, in relapse C95.10 Chronic leukemia of unspecified cell type not having achieved remission C95.11 Chronic leukemia of unspecified cell type, in remission C95.12 Chronic leukemia of unspecified cell type, in relapse C95.90 Leukemia, unspecified not having achieved remission C95.91 Leukemia, unspecified, in remission C95.92 Leukemia, unspecified, in relapse D45 Polycythemia vera III. For the treatment of aplastic anemia; see table below for ICD-10- CM codes) If ICD- 10-CM is applicable, the following ranges of ICD- 10-CM codes are also covered for AuSCT: Resistant non-Hodgkins lymphomas, ICD-10-CM diagnosis codes C82.01- C85.29, C85.81- C86.6, C96.4, and C96.Z -C96.9. Tandem transplantation (multiple rounds of autologous stem cell transplantation) for patients with multiple myeloma, ICD -10-CM codes C90.00, C90.01, C90.02 and D47.Z9 NOTE: The following conditions are not covered: Acute leukemia not in remission Chronic granulocytic leukemia Solid tumors (other than neuroblastoma) Multiple myeloma For Medicare beneficiaries age 64 or older, all forms of amyloidosis, primary and non-primary Non-primary amyloidosis Also coverage for conditions other than those specifically designated as covered in 90.2 or specifically designated as non -covered in this section or in 90.3will be at the discretion of the individual contractor. ICD-10 Description D60.0 Chronic acquired pure red cell aplasia D60.1 Transient acquired pure red cell aplasia D60.8 Other acquired pure red cell aplasias D60.9 Acquired pure red cell aplasia, unspecified D61.01 Constitutional (pure) red blood cell aplasia D61.09 Other constitutional aplastic anemia D61.1 Drug -induced aplastic anemia D61.2 Aplastic anemia due to other external agents D61.3 Idiopathic aplastic anemia D61.810 Antineoplastic chemotherapy induced pancytopenia D61.811 Other drug-induced pancytopenia D61.818 Other pancytopenia D61.82 Myelophthisis D61.89 Other specified aplastic anemias and other bone marrow failure syndromes D61.9 Aplastic anemia, unspecified 90.3 - Non-Covered Conditions (Rev.11035, Issued:10 -13-21, Effective: 11-17-21; Implementation: 11-17-21) Autologous stem cell transplantation is not covered for the following conditions:

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Autologous stem cell transplantation is not covered for the following conditions: a) Acute leukemia not in remission prior to October 1, 2000 (if ICD -10-CM is applicable, ICD -10-CM codes C91.00, C92.00, C93.00, C94.00, and C95.00) b) Chronic granulocytic leukemia prior to October 1, 2000 (if ICD-10-CM is applicable, ICD-10-CM code C92.10); c) Solid tumors prior to October 1, 2000 (other than neuroblastoma) (if ICD - 10-CM is applicable, ICD-10-CM codes C00.0 C80.2 and D00.0 D09.9); d) Multiple myeloma prior to October 1, 2000 (if ICD -10-CM is applicable, ICD-10-CM codes C90.00, C90.01, C90.02 and D47.Z9); e) Tandem transplantation, on or after October 1, 2000 (if ICD -10-CM is applicable, ICD-10-CM codes C90.00, C90.01, C90.02, and D47.Z9) ; f) Non- primary amyloidosis on or after 10/01/00, for all Medicare beneficiaries g) Primary AL amyloidosis effective October 1, 2000, through March 14, 2005 for Medicare beneficiaries age 64. (if ICD-10-CM is applicable, ICD-10- CM codes E85.4, E85.81, E85.9, and E85.89); NOTE: Coverage for conditions other than those specifically designated as covered in 90.2 or 90.2.1 or specifically designated as non -covered in this section will be at the discretion of the individual A/B MAC (B). 90.4 - Edits (Rev.11035, Issued:10 -13-21, Effective: 11-17-21; Implementation: 11-17-21) NOTE: Coverage for conditions other than those specifically designated as covered in 80.2 or specifically designated as non- covered in this section will be at the discretion of the individual A/B MAC (B). Appropriate diagnosis to procedure code edits should be implemented for the non-covered conditions and services in 90.2 90.2.1, and 90.3 as applicable As the ICD-10-CM codes E85.4, E85.81, E85.89, and E85.9 amyloidosis does not differentiate between primary and non-primary, A/B MACs (B) should perform prepay reviews on all claims with a diagnosis of ICD -10-CM codes E85.4, E85.81, E85.89, and E85.9 and a HCPCS procedure code of 38241 to determine whether payment is appropriate. 90.5 - Suggested MSN and RA Messages (Rev.11035, Issued:10 -13-21, Effective: 11-17-21; Implementation: 11-17-21) The contractor shall use an appropriate MSN and CARC message such as the following: MSN - 15.4, The information provided does not support the need for this service or item; CARC - 150, Payment adjusted because the payer deems the information submitted does not support this level of service. 90.6 - Clinical Trials for Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for Myelodysplastic Syndrome (MDS) (Rev. 11035, Issued:10 -13-21, Effective: 11-17-21; Implementation: 11-21) Myelodysplastic Syndrome (MDS) refers to a group of diverse blood disorders in which the bone marrow does not produce enough healthy, functioning blood cells. These disorders are varied with regard to clinical characteristics, cytologic and pathologic features, and cytogenetics. On August 4, 2010, the Centers for Medicare & Medicaid Services (CMS) issued a national coverage determination (NCD) stating that CMS believes that the evidence does not demonstrate that the use of allogeneic hematopoietic stem cell transplantation (HSCT) improves health outcomes in Medicare beneficiaries with MDS. Therefore, allogeneic HSCT for MDS is not reasonable and necessary under 1862(a)(1)(A) of the Social Security Act (the Act). However, allogeneic HSCT for MDS is reasonable and necessary under 1862(a)(1)(E) of the Act and therefore covered by Medicare ONLY if provided pursuant to a Medicare -approved clinical study under Coverage with Evidence Development (CED). Refer to Pub.100- 03, National Coverage Determinations Manual, Chapter 1, section 110.8.1, for more information about this policy, and Pub. 100- 04, Medicare Claims Processing Manual, Chapter 3, section 90.3.1, for information on CED. B Adjudication Requirements Payable Conditions. For claims with dates of service on and after August 4, 2010, contractors shall pay for claims for HSCT for MDS when the service was provided pursuant to a Medicare -approved clinical study under CED; these services are paid only in the inpatient setting (Type of Bill (TOB) 11X), as outpatient Part B (TOB 13X), and in Method II critical access hospitals (TOB 85X). Contractors shall require the following coding in order to pay for these claims: Existing Medicare -approved clinical trial coding conventions, as required in Pub. 100- 04, Medicare Claims Processing Manual, Chapter 32, section 69, and inpatient billing requirements regarding acquisition of stem cells in Pub. 100- 04, Medicare Claims Processing Manual, Chapter 3, section 90.3.3. If ICD -10-CM is applicable, ICD -10-PCS, procedure codes 30230C0, 30230G0, 30230Y0, 30233G0, 30233C0, 30233Y0, 30240C0, 30240G0, 30240Y0, 30243C0, 30243G0, and30243Y0 If Outpatient Hospital or Professional Claims: HCPCS procedure code 38240 If ICD -10-CM is applicable, ICD -10-CM diagnosis codes, D46.A, D46.B, D46.C, D46.Z, D46.0, D46.1, D46.20, D46.21, D46.22, D46.4, D46.9, and Z00.6 Professional claims only: place of service codes 21 or 22. Denials. Contractors shall deny claims failing to meet any of the above criteria. In addition, contractors shall apply the following requirements: Providers shall issue a hospital issued notice of non-coverage (HINN) or advance beneficiary notice (ABN) to the beneficiary if the services performed are not provided in accordance with CED. Contractors shall deny claims that do not meet the criteria for coverage with the following messages: CARC 50 - These are non -covered services because this is not deemed a 'medical necessity' by the payer. NOTE: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. 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 a t http://www.cms.hhs.gov/mcd/search.asp. If you do not have web access, you may contact the contractor to request a copy of the NCD. Group Code Patient Responsibility (PR) if HINN/ABN issued, otherwise Contractual Obligation (CO) MSN 16.77 This service/item was not covered because it was not provided as part of a qualifying trial/study. (Este servicio/artculo no fue cubierto porque no estaba incluido como parte de un ensayo clnico/estudio calificado.) 100 Billing Requirements for Expanded Coverage of Cochlear Implantation (Rev. 11875; Issued:02- 23-23; Effective: 09 -26-22; Implementation: 03 -24-23) Effective for dates of services on and after September 26, 2022, the Centers for Medicare & Medicaid Services (CMS) has expanded the coverage for cochlear implantation to cover bilateral pre- or post - linguistic, sensorineural, moderate -to-profound hearing loss in individuals with hearing test scores equal to or less than 60% correct in the best aided listening condition on recorded tests of open -set sentence recognition and who demonstrate limited benefit from amplification. (See Publication 100 -03, Chapter 1, Section 50.3, for complete coverage criteria). In addition, CMS is covering cochlear implants for beneficiaries not meeting the coverage criteria listed under Publication 100- 03, Chapter 1, Section 50.3 when performed in context with: A Food and Drug Administration (FDA) -approved category B investigational device exemption (IDE) clinical trial as defined at 42 CFR 405.201; or As a routine cost in a clinical trial under the CMS clinical trial policy (see Pub. 100 -03, section 310.1). 100.1 A/B MACs (Part A) Billing Procedures (Rev. 11875; Issued:02- 23-23; Effective: 09 -26-22; Implementation: 03 -24-23) There are no special payment methods. Existing payment methods shall apply. 100.1.1 Applicable Bill Types (Rev. 601, Issued: 07- 01-05; Effective: 04 -04-05; Implementation: 07 -25-05) 11X, 12X (see note below), 13X, 83X, 85X NOTE : Surgical procedures are not acceptable on 12x bill types. 100.1.2 Special Billing Requirements for A/B MACs (A) for Inpatient Billing (Rev. 11875; Issued:02- 23-23; Effective: 09 -26-22; Implementation: 03 -24-23) The second or subsequent diagnosis code must be ICD -10-CM Z00.6 (Encounter for exam for normal comparison and control in clinical research program). These diagnoses alert the claims processing system that this is a clinical trial. For patients in an FDA -approved category B IDE clinical trial the - Q0 modifier must be reported with the cochlear implantation device and all other related costs or; (see note below) 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.

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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.

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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. For further coverage information, please refer to the National Coverage Determinations Manual, Pub. 100-03, chapter 1, section 150.2. 110.2 Intermediary Billing Requirements (Rev. 597, Issued: 06-24-05, Effective: 04-27-05, Implementation: 08-01-05) The RHHIs will pay for ultrasonic osteogenic stimulators only when services are submitted on type of bills (TOBs) listed under Pub. 100- 04, Medicare Claims Processing Manual, chapter 32, section 100.3. Fiscal intermediaries (FIs) must educate hospitals that there are no covered services for Ultrasonic Osteogenic Stimulation for which hospitals can be paid by the FI. NOTE: Hospitals can not bill for Ultrasonic Osteogenic Stimulators. 110.3 Bill Types (Rev. 597, Issued: 06- 24-05, Effective: 04 -27-05, Implementation: 08- 01-05) Only the following TOBs can bill for Ultrasonic Osteogenic Stimulators: 32X, 33X, 34X, which is payable under the DMEPOS Fee Schedule. NOTE: Ultrasonic Osteogenic Stimulators must be in the patients home health plan of care if billed on TOBs 32X or 33X. 110.4 Carrier and Intermediary Billing Instructions (Rev. 597, Issued: 06- 24-05, Effective: 04 -27-05, Implementation: 08- 01-05) Effective for dates of service on or after April 27, 2005, contractors shall allow payment for ultrasonic osteogenic stimulators with the following current procedural terminology (CPT) code: 20979 - Low intensity ultrasound stimulation to aid bone healing, noninvasive (nonoperative) 110.5 DMERC Billing Instructions (Rev. 816, Issued: 01- 20-06, Effective: 04 -27-05, Implementation: 04- 03-06) Effective for dates of service on or after April 27, 2005, DMERCs shall allow payment for ultrasonic osteogenic stimulators with the following HCPCS codes: E0760 for low intensity ultrasound (include modifier KF), or; E1399 for other ultrasound stimulation (include modifier KF) 120 - Presbyopia- Correcting (P -C IOLS) and Astigmatism -Correcting Intraocular Lenses (A -C IOLs) (General Policy Information) (Rev. 1228; Issued: 04- 27-07; Effective: 01 -22-07; Implementation: 05 -29-07) Per CMS Ruling 05- 01, issued May 3, 2005, Medicare will allow beneficiaries to pay additional charges associated with insertion of a P -C IOL following cataract surgery. Presbyopia is a type of age -associated refractive error that results in progressive loss of the focusing power of the lens of the eye, causing difficulty seeing objects at near distance, or close -up. Presbyopia occurs as the natural lens of the eye becomes thicker and less flexible with age. A presbyopia -correcting IOL is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia (absence of the lens of the eye) following cataract extraction that is intended to provide near, intermediate and distance vision without the need for eyeglasses or contact lenses. Per CMS -1536- Ruling, effective for services on and after January 22, 2007, Medicare will allow beneficiaries to pay additional charges (which are non- covered by Medicare as these additional charges are not part of a Medicare benefit category) for insertion of an A- C IOL. Regular astigmatism is a visual condition where part of an image is blurred due to uneven corneal curvature. A normal cornea has the same curvature at all axes, whereas the curvature of an astigmatic cornea differs in two primary axes, resulting in vision that is distorted at all distances. The A -C IOL is intended to provide what is otherwise achieved by two separate items; an implantable conventional IOL (one that is not astigmatism- correcting) that is covered by Medicare, and the surgical correction, eyeglasses or contact lenses that are no t covered by Medicare. A list of A -C IOLs and P- C IOLs can be accessed online at http://www.cms.hhs.gov/HospitalOutpatientPPS/01_overview.asp 120.1 - Payment for Services and Supplies (Rev. 1430; Issued: 02-01- 08; Effective: 01 -01-08; Implementation: 03 -03-08) For an IOL inserted following removal of a cataract in a hospital, on either an outpatient or inpatient basis, that is paid under the hospital Outpatient Prospective Payment System (OPPS) or the Inpatient Prospective Payment System (IPPS), respectively; or in a Medicare -approved ambulatory surgical center (ASC) that is paid under the ASC fee schedule: Medicare does not make separate payment to the hospital or ASC for an IOL inserted subsequent to extraction of a cataract. Payment for the IOL is packaged into the payment for the surgical cataract extraction/lens replacement procedure. Any person or ASC, who presents or causes to be presented a bill or request for payment for an IOL inserted during or subsequent to cataract surgery for which payment is made under the ASC fee schedule, is subject to a civil money penalty. For a P -C IOL or A -C IOL inserted subsequent to removal of a cataract in a hospital, on either an outpatient or inpatient basis, that is paid under the OPPS or the IPPS, respectively; or in a Medicare-approved ASC that is paid under the ASC fee schedule: The facility shall bill for the removal of a cataract with insertion of a conventional IOL, regardless of whether a conventional, P -C IOL, or A -C IOL is inserted. When a beneficiary receives a P -C or A -C IOL following removal of a cataract, hospitals and ASCs shall report the same CPT code that is used to report removal of a cataract with insertion of a conventional IOL. Physicians, hospitals and ASCs may also report an additional HCPCS code, V2788, to indicate any additional charges that accrue when a P -C IOL or A -C IOL is inserted in lieu of a conventional IOL until January 1, 2008. Effective for A -C IOL insertion services on or after January 1, 2008, physicians, hospitals and ASCs should use V2787 to report any additional charges that accrue. On or after January 1, 2008, physicians, hospitals, and ASCs should continue to report HCPCS code V2788 to indicate any additional charges that accrue for insertion of a P-C IOL. See Section 120.2 for coding guidelines. There is no Medicare benefit category that allows payment of facility charges for services and supplies required to insert and adjust a P- C or A -C IOL following removal of a cataract that exceed the facility charges for services and supplies required for the insertion and adjustment of a conventional IOL. There is no Medicare benefit category that allows payment of facility charges for subsequent treatments, services and supplies required to examine and monitor the beneficiary who receives a P -C or A-C IOL following removal of a cataract that exceeds the fa cility charges for subsequent treatments, services and supplies required to examine and monitor a beneficiary after cataract surgery followed by insertion of a conventional IOL. A - For a P -C IOL or A -C IOL inserted in a physician's office - A physician shall bill for a conventional IOL, regardless of a whether a conventional, P -C IOL, or A -C IOL is inserted (see section 120.2, General Billing Requirements) - There is no Medicare benefit category that allows payment of physician charges for services and supplies required to insert and adjust a P -C or A -C IOL following removal of a cataract that exceed the physician charges for services and supplies for the insertion and adjustment of a conventional IOL. - There is no Medicare benefit category that allows payment of physician charges for subsequent treatments, service and supplies required to examine and monitor a beneficiary following removal of a cataract with insertion of a P -C or A -C IOL that exceed physician charges for services and supplies to examine and monitor a beneficiary following removal of a cataract with insertion of a conventional IOL. B - For a P -C IOL or A -C IOL inserted in a hospital - A physician may not bill Medicare for a P -C or A -C IOL inserted during a cataract procedure performed in a hospital setting because the payment for the lens is included in the payment made to the facility for the surgical procedure. - There is no Medicare benefit category that allows payment of physician charges for services and supplies required to insert and adjust a P -C or A -C IOL following removal of a cataract that exceed the physician charges for services and supplies require d for the insertion of a conventional IOL. C - For a P -C IOL or A -C IOL inserted in an Ambulatory Surgical Center - Refer to Chapter 14, Section 40.3 for complete guidance on payment for P -C IOL or A -C IOL in Ambulatory Surgical Centers. 120.2 - Coding and General Billing Requirements (Rev. 1430; Issued: 02- 01-08; Effective: 01 -01-08; Implementation: 03 -03-08) Physicians and hospitals must report one of the following Current Procedural Terminology (CPT) codes on the claim: 66982 - Extracapsular cataract removal with insertion of intraocular lens prosthesis (one stage procedure), manual or mechanical technique (e.g., irrigation and aspiration or phacoemulsification), complex requiring devices or techniques not generally used in routine cataract surgery (e.g., iris expansion device, suture support for intraocular lens, or primary posterior capsulorrhexi s) or performed on patients in the amblyogenic development stage. 66983 - Intracapsular cataract with insertion of intraocular lens prosthesis (one stage procedure) 66984 - Extracapsular cataract removal with insertion of intraocular lens prosthesis (one stage procedure), manual or mechanical technique (e.g., irrigation and aspiration or phacoemulsification) 66985 - Insertion of intraocular lens prosthesis (secondary implant), not associated with concurrent cataract extraction 66986 - Exchange of intraocular lens In addition, physicians inserting a P -C IOL or A -C IOL in an office setting may bill code V2632 (posterior chamber intraocular lens) for the IOL. Medicare will make payment for the lens based on reasonable cost for a conventional IOL. Place of Service (PO S) = 11. Effective for dates of service on and after January 1, 2006, physician, hospitals and ASCs may also bill the non-covered charges related to the P -C function of the IOL using HCPCS code V2788. Effective for dates of service on and after January 22, 2007 through January 1, 2008, non- covered charges related to A -C function of the IOL can be billed using HCPCS code V2788. The type of service indicator for the non -covered billed charges is Q. (The type of service is applied by the Medicare carrier and not the provider). Effective for A -C IOL insertion services on or after January 1, 2008, physicians, hospitals and ASCs should use V2787 rather than V2788 to report any additional charges that accrue.

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66986 - Exchange of intraocular lens In addition, physicians inserting a P -C IOL or A -C IOL in an office setting may bill code V2632 (posterior chamber intraocular lens) for the IOL. Medicare will make payment for the lens based on reasonable cost for a conventional IOL. Place of Service (PO S) = 11. Effective for dates of service on and after January 1, 2006, physician, hospitals and ASCs may also bill the non-covered charges related to the P -C function of the IOL using HCPCS code V2788. Effective for dates of service on and after January 22, 2007 through January 1, 2008, non- covered charges related to A -C function of the IOL can be billed using HCPCS code V2788. The type of service indicator for the non -covered billed charges is Q. (The type of service is applied by the Medicare carrier and not the provider). Effective for A -C IOL insertion services on or after January 1, 2008, physicians, hospitals and ASCs should use V2787 rather than V2788 to report any additional charges that accrue. When denying the non- payable charges submitted with V2787 or V2788, contractors shall use an appropriate Medical Summary Notice (MSN) such as 16.10 (Medicare does not pay for this item or service) and an appropriate claim adjustment reason code such as 96 (non- covered charges) for claims submitted with the non-payable charges. Hospitals and physicians may use the proper CPT code(s) to bill Medicare for evaluation and management services usually associated with services following cataract extraction surgery, if appropriate. A - Applicable Bill Types The hospital applicable bill types are 12X, 13X, 83X and 85X. B - Other Special Requirements for Hospitals Hospitals shall continue to pay CAHs method 2 claims under current payment methodologies for conditional IOLs. 120.3 - Provider Notification Requirements (Rev. 1228; Issued: 04- 27-07; Effective: 01 -22-07; Implementation: 05 -29-07) When a beneficiary requests insertion of a P -C or A -C IOL instead of a conventional IOL following removal of a cataract: Prior to the procedure to remove a cataractous lens and insert a P -C or A -C lens, the facility and the physician must inform the beneficiary that Medicare will not make payment for services that are specific to the insertion, adjustment or other subsequent treatments related to the P-C or A -C functionality of the IOL. The P -C or A -C functionality of a P -C or A -C IOL does not fall into a Medicare benefit category, and, therefore, is not covered. Therefore, the facility and physician are not required to provide an Advanced Beneficiary Notice to beneficiaries who request a P -C or A -C IOL. Although not required, CMS strongly encourages facilities and physicians to issue a Notice of Exclusion from Medicare Benefits to beneficiaries in order to clearly identify the non- payable aspects of a P -C or A -C IOL insertion. This notice may be found in English at http:\\cms.hhs.gov/medicare/bni/20007_English.pdf Spanish language at: http://cms.hhs.gov/medicare/bni/20007_Spanish.pdf . 120.4 - Beneficiary Liability (Rev. 1228; Issued: 04-27- 07; Effective: 01 -22-07; Implementation: 05 -29-07) When a beneficiary requests insertion of a P -C or A -C IOL instead of a conventional IOL following removal of a cataract and that procedure is performed, the beneficiary is responsible for payment of facility and physician charges for services and supplies attributable to the P -C or A -C functionality of the P- C or A -C IOL: In determining the beneficiary's liability, the facility and physician may take into account any additional work and resources required for insertion, fitting, vision acuity testing, and monitoring of the P -C or A -C IOL that exceed the work and resources attributable to insertion of a conventional IOL. The physician and the facility may not charge for cataract extraction with insertion of a P- C or A -C IOL unless the beneficiary requests this service. o The physician and the facility may not require the beneficiary to request a P- C or A -C IOL as a condition of performing a cataract extraction with IOL insertion. 130 - External Counterpulsation (ECP) Therapy (Rev. 898, Issued: 03- 31-06; Effective/Implementation Dates: 03 -31-06) Commonly referred to as enhanced external counterpulsation, is a non- invasive outpatient treatment for coronary artery disease refractory medical and/or surgical therapy. Effective for dates of service July 1, 1999, and after, Medicare will cover ECP when its use is in patients with stable angina (Class III or Class IV, Canadian Cardiovascular Society Classification or equivalent classification) who, in the opinion of a cardiologist or cardiothoracic surgeon, are not readily amenable to surgical intervention, such as PTCA or cardiac bypass, becaus e: Their condition is inoperable, or at high risk of operative complications or post- operative failure; Their coronary anatomy is not readily amenable to such procedures; or They have co -morbid states that create excessive risk. (Refer to Publication 100-03, section 20.20 for further coverage criteria.) 130.1 - Billing and Payment Requirements (Rev. 12109; Issued:06-29- 23; Effective: 10 -02-23; Implementation: 10-02-23) Effective for dates of service on or after January 1, 2000, use HCPCS code G0166 (External counterpulsation, per session) to report ECP services. The codes for external cardiac assist (92971), ECG rhythm strip and report (93040 or 93041), pulse oximetry (94760 or 94761) and plethysmography (93922 or 93923) or other monitoring tests for examining the effects of this treatment are not clinically necessary with this service and should not be paid on the same day, unless they occur in a clinical setting not connected with the delivery of the ECP. Daily evaluation and management service, e.g., 99201- 99205, 99211- 99215, 99217- 99220, 99241-99245, and G0463 cannot be billed with the ECP treatments. Any evaluation and management service must be justified with adequate documentation of the medical necessity of the visit. Deductible and coinsurance apply. Note: Please note that effective December 31, 2020 evaluation and management service code 99201 is end-dated. Effective December 31, 2022 codes 99217,99218,99219,99220 and 99241 are end dated. For Part A, remove CPT codes 99202- 99215, 99242- 99245 and repl ace with G0463 (the OPPS equivalent of E/M codes) effective retroactive to 10/1/2015. 130.2 - Special Intermediary Billing and Payment Requirements (Rev. 898, Issued: 03- 31-06; Effective/Implementation Dates: 03 -31-06) Payment is made to hospitals for the facility costs it incurs under Part B on a reasonable cost basis. Payment is also made to PPS -exempt hospitals for the facility costs it incurs on a reasonable cost basis. Deductible and coinsurance apply. Applicable bill types are 12X, 13X, 83X or 85X. 140 - Cardiac Rehabilitation (CR) Programs, Intensive Cardiac Rehabilitation (ICR) Programs, and Pulmonary Rehabilitation (PR) Programs On or After January 1, 2024 (Rev. 12497; Issued: 02- 08-24; Effective: 01 -01-24; Implementation: 03 -12-24) Cardiac rehabilitation (CR) means a physician or nonphysician practitioner supervised program that furnishes physician prescribed exercise; cardiac risk factor modification, including education, counseling, and behavioral intervention; psychosocial assessment; and outcomes assessment. Intensive cardiac rehabilitation (ICR) progra m means a physician or nonphysician practitioner supervised program that furnishes CR and has shown, in peer -reviewed published research, that it improves patients cardiovascular disease through specific outcome measurements described in 42 CFR 410.49(c). Nonphysician practitioner means a physician assistant, nurse practitioner, or clinical nurse specialist as those terms are defined in section 1861(aa)(5)(A) of the Social Security Act (the Act). Effective January 1, 2024, Medicare Part B pays for CR/ICR if specific criteria are met by the Medicare beneficiary, the CR/ICR program itself, the setting in which it is administered, and the physician a dministering the program. Pulmonary rehabilitation (PR) means a physician or nonphysician practitioner supervised program for chronic obstructive pulmonary disease (COPD) and certain other chronic respiratory diseases designed to optimize physical and social performance and autonomy. Nonphysician practitioner means a physician assistant, nurse practitioner, or clinical nurse specialist as those terms are defined in section 1861(aa)(5)(A) of the Act. Effective January 1, 2024, Medicare Part B pays for PR if specific criteria are met by the Medicare beneficiary, the PR program itself, the setting in which it is administered, and the physician administering the program, as outlined below. 140.1 CR Program Services Furnished On or Before December 31, 2009 (Rev. 11426; Issued: 05- 20-22; Effective: 01 -01-22; Implementation: 07 -05-22) Medicare covers CR exercise programs for patients who meet the following criteria: Have a documented diagnosis of acute myocardial infarction (MI) within the preceding 12 months; or Have had coronary bypass surgery; or, Have stable angina pectoris; or, Have had heart valve repair/replacement; or, Have had percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting; or, Have had a heart or heart -lung transplant. Effective for dates of services on or after March 22, 2006, services provided in connection with a CR exercise program may be considered reasonable and necessary for up to 36 sessions. Patients generally receive 2 to 3 sessions per week for 12 to 18 weeks. The contractor has discretion to cover CR beyond 18 weeks. Coverage must not exc eed a total of 72 sessions for 36 weeks. CR programs shall be performed incident to physicians services in outpatient hospitals, or outpatient settings such as clinics or offices. Follow the policies for services incident to the services of a physician as they apply in each setting. For example, see Pub. 100-02, Chapter 6, 2.4.1, and Pub. 100-02, Chapter 15, 60.1. (Refer to Publication 100-03, 20.10 for further coverage guidelines.) 140.1.1 - Coding Requirements for Cardiac Rehabilitation Services Furnished On or Before Dec. 31, 2009 (Rev. 12497; Issued: 02-08- 24; Effective: 01 -01-24; Implementation: 03-12-24) The following are the applicable Healthcare Common Procedure Coding System (HCPCS) codes: 93797 - Physician or other qualified health care professional services for outpatient cardiac rehabilitation; without continuous ECG monitoring (per session); and 93798 - Physician or other qualified health care professional services for outpatient cardiac rehabilitation; with continuous ECG monitoring (per session). Note: The above HCPCS descriptors are effective January 1, 2013. Effective for dates of service on or after January 1, 2008, and before January 1, 2010, providers and practitioners may report more than one unit of CPT code 93797 or 97398 for a date of service if more than one CR session lasting at least 1 hour each is provided on the same day. In order to report more than one session for a given date of service, each session must last a minimum of 60 minutes. For example, if the CR provided on a given day total 1 hour and 50 minutes, then only one session should be billed to report the CR provided on that day. 140.2 Cardiac Rehabilitation Program Services Effective for Dates of Service On or After January 1, 2024 (Rev. 12497; Issued: 02-08- 24; Effective: 01 -01-24; Implementation: 03-12-24)

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The following are the applicable Healthcare Common Procedure Coding System (HCPCS) codes: 93797 - Physician or other qualified health care professional services for outpatient cardiac rehabilitation; without continuous ECG monitoring (per session); and 93798 - Physician or other qualified health care professional services for outpatient cardiac rehabilitation; with continuous ECG monitoring (per session). Note: The above HCPCS descriptors are effective January 1, 2013. Effective for dates of service on or after January 1, 2008, and before January 1, 2010, providers and practitioners may report more than one unit of CPT code 93797 or 97398 for a date of service if more than one CR session lasting at least 1 hour each is provided on the same day. In order to report more than one session for a given date of service, each session must last a minimum of 60 minutes. For example, if the CR provided on a given day total 1 hour and 50 minutes, then only one session should be billed to report the CR provided on that day. 140.2 Cardiac Rehabilitation Program Services Effective for Dates of Service On or After January 1, 2024 (Rev. 12497; Issued: 02-08- 24; Effective: 01 -01-24; Implementation: 03-12-24) As specified at 42 CFR 410.49, Medicare Part B covers CR for beneficiaries who have experienced one or more of the following: An acute MI within the preceding 12 months; A coronary artery bypass surgery; Current stable angina pectoris; Heart valve repair or replacement; PTCA or coronary stenting; A heart or heart -lung transplant; Stable, chronic heart failure defined as patients with left ventricular ejection fraction of 35% or less and New York Heart Association (NYHA) class II to IV symptoms despite being on optimal heart failure therapy for at least 6 weeks, on or after February 18, 2014; or, Other cardiac conditions as specified through a national coverage determination (NCD). CR must include all of the following components: Physician prescribed exercise each day CR items and services are furnished. Cardiac risk factor modification, including education, counseling, and behavioral intervention, tailored to the individuals needs. Psychosocial assessment. Outcomes assessment. An individualized treatment plan detailing how components are utilized for each patient. The individualized treatment plan must be established, reviewed, and signed by a physician every 30 days. Medicare Part B pays for CR in a physicians office or a hospital outpatient setting. All settings must have a physician or nonphysician practitioner immediately available and accessible for medical consultations and emergencies at all times when items and services are being furnished under the program. This provision is satisfied if the physician or nonphysician practitioner meets the requirements for direct supervision for physician office services, at 42 CFR 410.26, and for hospital outpatient services a t 42 CFR 410.27. Note: Nonphysician practitioners are eligible to supervise CR effective January 1, 2024. As specified at 42 CFR 410.49(f)(1), the number of CR sessions are limited to a maximum of 2 1-hour sessions per day for up to 36 sessions over up to 36 weeks with the option for an additional 36 sessions over an extended period of time if approved by the Medicare Administrative Contractor (MAC). 140.2.1 Coding Requirements for CR Services Furnished On or After January 1, 2010 (Rev. 12497; Issued: 02- 08-24; Effective: 01 -01-24; Implementation: 03 -12-24) The following are the applicable Current Procedural Technology (CPT) codes for CR services: 93797 Physician or other qualified health care professional services for outpatient cardiac rehabilitation; without continuous ECG monitoring (Per Session) 93798 Physician or other qualified care health professional services for outpatient cardiac rehabilitation; with continuous ECG monitoring (Per Session) Note: The above HCPCS descriptors are effective January 1, 2013. Effective for dates of service on or after January 1, 2010, hospitals and practitioners may report a maximum of 2 1 -hour sessions per day. In order to report one session of CR in a day, the duration of treatment must be at least 31 minutes. Two sessions of CR may only be reported in the same day if the duration of treatment is at least 91 minutes. In other words, the first session would account for 60 minutes and the second session would account for at least 31 minutes if two sessions are reported. If seve ral shorter periods of CR are furnished on a given day, the minutes of service during those periods must be added together for reporting in 1-hour session increments. Example : If the patient receives 20 minutes of CR in the day, no CR session may be reported because less than 31 minutes of services were furnished. Example : If a patient receives 20 minutes of CR in the morning and 35 minutes of CR in the afternoon of a single day, the hospital or practitioner would report 1 session of CR under 1 unit of the appropriate CPT code for the total duration of 55 minutes of CR on that day. Example : If the patient receives 70 minutes of CR in the morning and 25 minutes of CR in the afternoon of a single day, the hospital or practitioner would report two sessions of CR under the appropriate CPT code(s) because the total duration of CR on that day of 95 minutes exceeds 90 minutes. Example : If the patient receives 70 minutes of CR in the morning and 85 minutes of CR in the afternoon of a single day, the hospital or practitioner would report two sessions of CR under the appropriate CPT code(s) for the total duration of CR of 155 minutes. A m aximum of two sessions per day may be reported, regardless of the total duration of CR. sessions after 36 (to include completed ICR sessions prior to switch). In these cases, and consistent with the information above, the - KX modifier must be included on the claim should the beneficiary participate in more than 36 CR sessions following the sw itch. See Pub. 100- 06, Medicare Financial Management Manual, chapter 6, section 420, and Pub. 100-02, Medicare Benefit Policy Manual, chapter 15, section 232, and Pub. 100- 08, Medicare Program Integrity Manual, chapter 10, section 10.2.2.5 for detailed information regarding CR and ICR policy and claims processing. 140.2.2 Claims Processing Requirements for Cardiac Rehabilitation (CR) and Intensive Cardiac Rehabilitation (ICR) Services Furnished On or After January 1, 2010 (Rev. 11426; Issued: 05- 20-22; Effective: 01 -01-22; Implementation: 07 -05-22) NOTE : A beneficiary may switch from an ICR program to a CR program. The beneficiary is limited to a one -time switch, multiple switches are not allowable. Once the beneficiary switches from ICR to CR he or she will be limited to the number of sessions remaining in the program. For example, a beneficiary who switches from ICR to CR after 12 sessions will have 24 sessions of CR remaining, (i.e., 12 sessions of ICR + 24 sessions of CR = total of 36 sessions). Should a beneficiary experience more than one indica tion simultaneously, he or she may participate in a single series of CR or ICR sessions (i.e., a patient who had a MI within 12 months and currently experiences stable angina is entitled to one series of CR sessions, up to 36 1- hour sessions with contractor discretion for an additional 36 sessions; or one series of ICR sessions, up to 72 1- hour sessions over a period up to 18 weeks). Beneficiaries may not switch from CR to ICR. Upon completion of a CR or ICR program, beneficiaries must experience another in dication in order to be eligible for coverage of more CR or ICR. Contractors shall accept the inclusion of the - KX modifier on the claim line(s) as an attestation by the provider of the service that documentation is on file verifying that further treatment beyond 36 sessions of CR up to a total of 72 sessions meets the requirements of the medical policy or, for ICR, that any further sessions beyond 72 sessions within a 126- day period counting from the date of the first session, or for any sessions provided after 126 days from the date of the first session, meet the requi rements of the medical policy. Beneficiaries who switch from ICR to CR may also be eligible for up to 72 combined sessions with contractor discretion for CR sessions after 36 (to include completed ICR sessions prior to switch). In these cases, and consiste nt with the information above, the - KX modifier must be included on the claim should the beneficiary participate in more than 36 CR sessions following the switch. See Pub. 100- 06, Medicare Financial Management Manual, chapter 6, section 420, and Pub. 100-02, Medicare Benefit Policy Manual, chapter 15, section 232, and Pub. 100- 08, Medicare Program Integrity Manual, chapter 10, section 10.2.2.5 for detailed information regarding CR and ICR policy and claims processing. 140.2.2.1 Correct Place of Service (POS) Code for CR and ICR Services on Professional Claims (Rev. 3058, Issued: 08- 29-14, Effective: 02 -18-14, Implementation: 08- 18-14) Effective for claims with dates of service on and after January 1, 2010, place of service (POS) code 11 shall be used for CR and ICR services provided in a physicians office and POS 22 shall be used for services provided in a hospital outpatient setting. All other POS codes shall be denied. Contractors shall adjust their prepayment procedure edits as appropriate. The following messages shall be used when contractors deny CR and ICR claims for POS: Claim Adjustment Reason Code (CARC) 171 Payment is denied when performed/billed by this type of provider in this type of facility. NOTE: Refer to the 832 Healthcare Policy Identification Segment (loop 2110 Service payment Information REF), if present. Remittance Advice Remark Code (RARC) N428 - Service/procedure not covered when performed in this place of service. Medicare Summary Notice (MSN) 21.25 - This service was denied because Medicare only covers this service in certain settings. Group Code PR (Patient Responsibility) - Where a claim is received with the GA modifier indicating that a signed ABN is on file. Group Code CO (Contractor Responsibility) Where a claim is received with the GZ modifier indicating that no signed ABN is on file. 140.2.2.2 Requirements for CR and ICR Services on Institutional Claims (Rev. 3084, Issued: 10- 03-14, Effective: 05 -06-14, Implementation: 11- 04-14) Effective for claims with dates of service on and after January 1, 2010, contractors shall pay for CR and ICR services when submitted on Types of Bill (TOBs) 13X and 85X only. All other TOBs shall be denied. The following messages shall be used when contractors deny CR and ICR claims for TOBs other than 13X and 85X: Claim Adjustment Reason Code (CARC) 171 Payment is denied when performed/billed by this type of provider in this type of facility. NOTE: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. Remittance Advice Remark Code (RARC) N428 - Service/procedure not covered when performed in this place of service. Medicare Summary Notice (MSN) 21.25 - This service was denied because Medicare only covers this service in certain settings. Group Code PR (Patient Responsibility) Where a claim is received with the GA modifier indicating that a signed ABN is on file. Group Code CO (Contractor Responsibility) Where a claim is received with the GZ modifier indicating that no signed ABN is on file. 140.2.2.3 Frequency Edits for CR and ICR Claims (Rev. 11426; Issued: 05- 20-22; Effective: 01 -01-22; Implementation: 07 -05-22) Effective for claims with dates of service on or after January 1, 2010, contractors shall deny all CR claims (both professional and institutional claims) that exceed 2 units per date of service for CR and 6 units per date of service for ICR. The following messages shall be used when contractors deny CR and ICR claims for exceeding units per date of service: CARC 119 - Benefit maximum for this time period or occurrence has been reached. RARC N362 - The number of days or units of service exceeds our acceptable maximum. MSN 20.5 - These services cannot be paid because your benefits are exhausted at this time. Spanish Version - Estos servicios no pueden ser pagados porque sus beneficios se han agotado.

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Group Code PR (Patient Responsibility) Where a claim is received with the GA modifier indicating that a signed ABN is on file. Group Code CO (Contractor Responsibility) Where a claim is received with the GZ modifier indicating that no signed ABN is on file. 140.2.2.3 Frequency Edits for CR and ICR Claims (Rev. 11426; Issued: 05- 20-22; Effective: 01 -01-22; Implementation: 07 -05-22) Effective for claims with dates of service on or after January 1, 2010, contractors shall deny all CR claims (both professional and institutional claims) that exceed 2 units per date of service for CR and 6 units per date of service for ICR. The following messages shall be used when contractors deny CR and ICR claims for exceeding units per date of service: CARC 119 - Benefit maximum for this time period or occurrence has been reached. RARC N362 - The number of days or units of service exceeds our acceptable maximum. MSN 20.5 - These services cannot be paid because your benefits are exhausted at this time. Spanish Version - Estos servicios no pueden ser pagados porque sus beneficios se han agotado. Group Code PR Where a claim is received with the GA modifier indicating that a signed ABN is on file. Group Code CO Where a claim is received with the GZ modifier indicating that no signed ABN is on file. Contractors shall not research and adjust CR claims (HCPCS 93797 and 93798) paid for more than 2 units on the same date of service processed prior to the implementation of edits. However, contractors may adjust claims brought to their attention. Contractors shall not research and adjust ICR claims (HCPCS G0422 and G0423) paid for more than 6 units on the same date of service processed prior to the implementation of edits. However, contractors may adjust claims brought to their attention. 140.2.2.4 Edits for CR Services Exceeding 36 Sessions (Rev. 11426; Issued: 05- 20-22; Effective: 01 -01-22; Implementation: 07 -05-22) Effective for claims with dates of service on or after January 1, 2010, contractors shall deny all claims with HCPCS 93797 and 93798 (both professional and institutional claims) that exceed 36 CR sessions when a - KX modifier is not included on the claim line. The following messages shall be used when contractors deny CR claims that exceed 36 sessions, when a - KX modifier is not included on the claim line: -CARC- ) 119 Benefit maximum for this period or occurrence has been reached. RARC N435 - Exceeds number/frequency approved/allowed within time period without support documentation. MSN 23.17- Medicare wont cover these services because they are not considered medically necessary. Spanish Version - Medicare no cubrir estos servicios porque no son considerados necesarios por razones mdicas. Group Code PR Where a claim is received with the GA modifier indicating that a signed ABN is on file. Group Code CO Where a claim is received with the GZ modifier indicating that no signed ABN is on file. Contractors shall not research and adjust CR claims paid for more than 36 sessions processed prior to the implementation of Common Working File (CWF) edits. However, contractors may adjust claims brought to their attention. 140.2.2.5 Edits for ICR Services Exceeding 126 Days and 72 Sessions (Rev. 1974, Issued: 05- 21-10, Effective: 01 -10-10, Implementation: 10- 04-10) Effective for claims with dates of service on and after January 1, 2010, CWF shall reject ICR claims (G0422 and G0423) that exceed 72 sessions or where any billed sessions were provided after126 days from the date of the first session and a KX modifier is not included on the claim line. The following messages shall be used when contractors deny ICR claims that exceed 72 sessions or where any billed sessions were received after the 126 days from the date of the first session: Claim Adjustment Reason Code (CARC) 119 - Benefit maximum for this time period or occurrence has been reached. RARC N435 - Exceeds number/frequency approved/allowed within time period without support documentation. MSN 20.5 - These services cannot be paid because your benefits are exhausted at this time. Spanish Version - Estos servicios no pueden ser pagados porque sus beneficios se han agotado. Group Code PR (Patient Responsibility) Where a claim is received with the GA modifier indicating that a signed ABN is on file. Group Code CO (Contractor Responsibility) Where a claim is received with the GZ modifier indicating that no signed ABN is on file. Contractors shall not research and adjust ICR claims paid for more than 72 sessions or where any billed sessions were received after 126 days from the date of the first session that were processed prior to the implementation of CWF edits. However, contrac tors may adjust claims brought to their attention. 140.2.2.6 Supplier Specialty Code 31 Requirements for ICR Claims (Rev. 1974, Issued: 05- 21-10, Effective: 01 -10-10, Implementation: 10- 04-10) Effective for claims with dates of service on and after January 1, 2010, contractors shall pay for ICR services when submitted by providers enrolled as the new supplier specialty code 31 for ICR. ICR services submitted by providers enrolled as other than t he new supplier specialty code 31 for ICR are to be denied using the following messages: CARC 8: The procedure code is inconsistent with the provider type/specialty (taxonomy). NOTE: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. RARC N95: This provider type may not bill this service. MSN 21.18 This item or service is not covered when performed or ordered by this provider. Spanish Version: Este servicio no est cubierto cuando es ordenado o rendido por este proveedor. Group Code PR (Patient Responsibility) Where a claim is received with the GA modifier indicating that a signed ABN is on file. Group Code CO (Contractor Responsibility) Where a claim is received with the GZ modifier indicating that no signed ABN is on file. 140.3 ICR Program Services Effective for Dates of Service On or After January 1, 2024 (Rev. 12497; Issued: 02-08- 24; Effective: 01 -01-24; Implementation: 03-12-24) As specified at 42 CFR 410.49, Medicare Part B covers ICR for beneficiaries who have experienced one or more of the following: An acute MI within the preceding 12 months; A coronary artery bypass surgery; Current stable angina pectoris; Heart valve repair or replacement; PTCA or coronary stenting; A heart or heart -lung transplant; Stable, chronic heart failure defined as patients with left ventricular ejection fraction of 35% or less and NYHA class II to IV symptoms despite being on optimal heart failure therapy for at least 6 weeks, on or after February 9, 2018; or, Other cardiac conditions as specified through an NCD. The NCD process may also be used to specify non-coverage of a cardiac condition for ICR if coverage is not supported by clinical evidence. ICR must include all of the following components: Physician prescribed exercise each day CR items and services are furnished. Cardiac risk factor modification, including education, counseling, and behavioral intervention, tailored to the individuals needs. Psychosocial assessment. Outcomes assessment. An individualized treatment plan detailing how components are utilized for each patient. The individualized treatment plan must be established, reviewed, and signed by a physician every 30 days. A list of approved ICR programs, identified through the NCD process, will be listed in the Federal Register and is available on the CMS website at https://www.cms.gov/Medicare/Medicare- General -Information/MedicareApprovedFacilitie/ICR . In order to be approved, a program must demonstrate through peer-reviewed, published research that it has accomplished one or more of the following for its patients: Positively affected the progression of coronary heart disease. Reduced the need for coronary bypass surgery. Reduced the need for percutaneous coronary interventions. An ICR program must also demonstrate through peer -reviewed published research that it accomplished a statistically significant reduction in 5 or more of the following measures for patients from their levels before CR services to after CR services: Low density lipoprotein. Triglycerides. Body mass index. Systolic blood pressure. Diastolic blood pressure. The need for cholesterol, blood pressure, and diabetes medications. Medicare Part B pays for ICR in a physicians office or a hospital outpatient setting. All settings must have a physician or nonphysician practitioner immediately available and accessible for medical consultations and emergencies at all times when items an d services are being furnished under the program. This provision is satisfied if the physician or nonphysician practitioner meets the requirements for direct supervision for physician office services, at 42 CFR 410.26, and for hospital outpatient services at 42 CFR 410.27. Note: Nonphysician practitioners are eligible to supervise ICR effective January 1, 2024. As specified at 42 CFR 410.49(f)(2), ICR sessions are limited to 72 1- hour sessions (as defined in section 1848(b)(5) of the Act), up to 6 sessions per day, over a period of up to 18 weeks. 140.3.1 Coding Requirements for ICR Services Furnished On or After January 1, 2010 (Rev. 11426; Issued: 05- 20-22; Effective: 01 -01-22; Implementation: 07 -05-22) The following are the applicable HCPCS codes for ICR: G0422 (Intensive cardiac rehabilitation; with or without continuous ECG monitoring, with exercise, per hour, per session) G0423 (Intensive cardiac rehabilitation; with or without continuous ECG monitoring, without exercise, per hour, per session) Effective for dates of service on or after January 1, 2010, hospitals and practitioners may report a maximum of 6 1 -hour sessions per day. In order to report one session of ICR in a day, the duration of treatment must be at least 31 minutes. Additional sessions of ICR beyond the first session may only be reported in the same day if the duration of treatment is 31 minutes or greater beyond the hour increment. In other words, in or der to report 6 sessions of ICR on a given date of service, the first five sessions would account for 60 minutes each and the sixth session would account for at least 31 minutes. If several shorter periods of ICR are furnished on a given day, the minutes of service during those periods must be added together for reporting in 1- hour session increments. Example : If the patient receives 20 minutes of ICR in the day, no ICR session may be reported because less than 31 minutes of services were furnished. Example : If a patient receives 20 minutes of ICR in the morning and 35 minutes of ICR in the afternoon of a single day, the hospital or practitioner would report 1 session of ICR under 1 unit of the appropriate HCPCS code for the total duration of 55 minutes of I CR on that day. Example : If the patient receives 70 minutes of ICR in the morning and 25 minutes of ICR in the afternoon of a single day, the hospital or practitioner would report two sessions of ICR under the appropriate HCPCS code(s) because the total duration of ICR on that day of 95 minutes exceeds 90 minutes. Example : If the patient receives 70 minutes of ICR in the morning and 85 minutes of ICR in the afternoon of a single day, the hospital or practitioner would report three sessions of ICR under the appropriate HCPCS code(s) because the total duration of ICR on that day is 155 minutes, which exceeds 150 minutes and is less than 211 minutes. 140.4 PR Program Services Effective for Dates of Service On or After January 1, 2024 (Rev. 12497; Issued: 02- 08-24; Effective: 01 -01-24; Implementation: 03 -12-24) As specified in 42 CFR 410.47, Medicare Part B covers PR for beneficiaries: With moderate to very severe COPD (defined as GOLD classification II, III and IV), when referred by the physician treating the chronic respiratory disease; Who have had confirmed or suspected COVID -19 and experience persistent symptoms that include respiratory dysfunction for at least four weeks (effective January 1, 2022); Additional medical indications for coverage for PR may be established through an NCD. PR must include all of the following components:

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140.4 PR Program Services Effective for Dates of Service On or After January 1, 2024 (Rev. 12497; Issued: 02- 08-24; Effective: 01 -01-24; Implementation: 03 -12-24) As specified in 42 CFR 410.47, Medicare Part B covers PR for beneficiaries: With moderate to very severe COPD (defined as GOLD classification II, III and IV), when referred by the physician treating the chronic respiratory disease; Who have had confirmed or suspected COVID -19 and experience persistent symptoms that include respiratory dysfunction for at least four weeks (effective January 1, 2022); Additional medical indications for coverage for PR may be established through an NCD. PR must include all of the following components: Physician prescribed exercise during each pulmonary rehabilitation session. Education or training that is closely and clearly related to the individuals care and treatment which is tailored to the individuals needs and assists in achievement of goals toward independence in activities of daily living, adaptation to limitations and improved quality of life. Education must include information on respiratory problem management and, if appropriate, brief smoking cessation counseling. Psychosocial assessment. Outcomes assessment. An individualized treatment plan detailing how components are utilized for each patient. The individualized treatment plan must be established, reviewed, and signed by a physician every 30 days. Medicare Part B pays for PR in a physicians office or a hospital outpatient setting. All settings must have the following: (i) A physician or nonphysician practitioner immediately available and accessible for medical consultations and emergencies at all t imes when items and services are being furnished under the program. This provision is satisfied if the physician or nonphysician practitioner meets the requirements for direct supervision for physician office services, at 42 CFR 410.26, and for hospital outpatient services at 42 CFR 410.27, and, (ii) The necessary cardio- pulmonary, emergency, diagnostic, and therapeutic life-saving equipment accepted by the medical community as medically necessary (for example, oxygen, cardiopulmonary resuscitation equipment, and defibrillator) to treat chronic respiratory disease. Note: Nonphysician practitioners are eligible to supervise PR effective January 1, 2024. As specified at 42 CFR 410.47(e), the number of PR sessions are limited to a maximum of 2 1-hour sessions per day for up to 36 sessions over up to 36 weeks with the option for an additional 36 sessions over an extended period of time if approved by the MAC s. 140.4.1 Coding Requirements for PR Services Furnished On or After January 1, 2010 (Rev. 11426; Issued: 05- 20-22; Effective: 01 -01-22; Implementation: 07 -05-22) The following are the applicable HCPCS codes for PR: Effective January 1, 2010 through December 31, 2021 G0424 (Pulmonary rehabilitation, including exercise (includes monitoring), per hour, per session) Effective January 1, 2022 94625 (Physician or other qualified health care professional services for outpatient pulmonary rehabilitation; without continuous oximetry monitoring (per session)) 94626 (Physician or other qualified health care professional services for outpatient pulmonary rehabilitation; with continuous oximetry monitoring (per session) Effective for dates of service on or after January 1, 2010, hospitals and practitioners may report a maximum of 2 1 -hour sessions per day. In order to report one session of PR in a day, the duration of treatment must be at least 31 minutes. Two sessions of PR may only be reported in the same day if the duration of treatment is at least 91 minutes. In other words, the first session would account for 60 minutes and the second session would account for at least 31 minutes, if two sessions are reported. If seve ral shorter periods of PR are furnished on a given day, the minutes of service during those periods must be added together for reporting in 1-hour session increments. Example : If the patient receives 20 minutes of PR in the day, no PR session may be reported because less than 31 minutes of services were furnished. Example : If a patient receives 20 minutes of PR in the morning and 35 minutes of PR in the afternoon of a single day, the hospital or practitioner would report 1 session of PR under 1 unit of HCPCS code/CPT code for the total duration of 55 minutes of PR on that day. Example : If the patient receives 70 minutes of pulmonary rehabilitation services in the morning and 25 minutes of pulmonary rehabilitation services in the afternoon of a single day, the hospital or practitioner would report two sessions of pulmonary rehabilitation services under the HCPCS G -code/CPT codes because the total duration of pulmonary rehabilitation services on that day of 95 minutes exceeds 90 minutes. Example : If the patient receives 70 minutes of pulmonary rehabilitation services in the morning and 85 minutes of pulmonary rehabilitation services in the afternoon of a single day, the hospital or practitioner would report two sessions of pulmonary rehabilitation services under the HCPCS G -code/CPT codes for the total duration of pulmonary rehabilitation services of 155 minutes. A maximum of two sessions per day may be reported, regardless of the total duration of pulmonary rehabilitation services. 140.4.2 Claims Processing Requirements for Pulmonary Rehabilitation (PR) Services Furnished On or After January 1, 2010 (Rev. 1966, Issued: 05- 07-10, Effective: 01 -01-10, Implementation: 10- 04-10) 140.4.2.1 Correct Place of Service (POS) Code for PR Services on Professional Claims (Rev. 11021; Issued: 10- 01-21; Effective: 10 -29-21; Implementation: 10 -29-21) Effective for claims with dates of service on and after January 1, 2010, place of service (POS) code 11 shall be used for pulmonary rehabilitation (PR) services provided in a physicians office and POS 22 shall be used for services provided in a hospital outpatient setting. All other POS codes shall be denied. Medicare contractors shall adjust their prepayment procedure edits as appropriate. The following messages shall be used when Medicare contractors deny PR claims for POS: CARC 96: Non- covered charge(s). RARC N428: Service/procedure not covered when performed in this place of service. Medicare Summary Notice (MSN) 21.25: This service was denied because Medicare only covers this service in certain settings. Spanish Version: El servicio fue denegado porque Medicare solamente lo cubre en ciertas situaciones." NOTE: This is a new MSN message. Contractors shall use Group Code PR (Patient `Responsibility) assigning financial liability to the beneficiary, if a claim is received with a GA modifier indicating a signed ABN is on file. Contractors shall use Group Code CO (Contractual Obligation) assigning financial liability to the provider, if a claim is received with a GZ modifier indicating no signed ABN is on file. 140.4.2.2 Requirements for PR Services on Institutional Claims (Rev. 11021; Issued: 10- 01-21; Effective: 10 -29-21; Implementation: 10 -29-21) Effective for claims with dates of service on and after January 1, 2010, Medicare contractors shall pay for PR services when submitted on a type of bill (TOB) 13X and 85X only, along with revenue code 0948. All other TOBs shall be denied. The following messages shall be used when Medicare contractors deny PR claims for TOB: CARC 96: Non- covered charge(s). RARC N428: Service/procedure not covered when performed in this place of service. Medicare Summary Notice (MSN) 21.25: This service was denied because Medicare only covers this service in certain settings. Spanish Version: El servicio fue denegado porque Medicare solamente lo cubre en ciertas situaciones." NOTE: This is a new MSN message. Contractors shall use Group Code PR (Patient `Responsibility) assigning financial liability to the beneficiary, if a claim is received with a GA modifier indicating a signed ABN is on file. Contractors shall use Group Code CO (Contractual Obligation) assigning financial liability to the provider, if a claim is received with a GZ modifier indicating no signed ABN is on file. 140.4.2.3 Daily Frequency Edits for PR Claims (Rev. 1966, Issued: 05- 07-10, Effective: 01 -01-10, Implementation: 10- 04-10) Effective for claims with dates of service on or after January 1, 2010, Medicare contractors shall deny all PR claims (both professional and institutional claims) that exceed two units on the same date of service. The following messages shall be used when Medicare contractors deny PR claims for exceeding the daily frequency limit: CARC 119: Benefit maximum for this time period or occurrence has been reached. RARC N362: The number of days or units of service exceeds our acceptable maximum. MSN 20.5: These services cannot be paid because your benefits are exhausted at this time. Spanish Version: Estos servicios no pueden ser pagados porque sus beneficios se han agotado. Contractors shall use Group Code PR (Patient Responsibility) assigning financial liability to the beneficiary, if a claim is received with a GA modifier indicating a signed ABN is on file. Contractors shall use Group Code CO (Contractual Obligation) assigning financial liability to the provider, if a claim is received with a GZ modifier indicating no signed ABN is on file. 140.4.2.4 Edits for PR Services Exceeding 36 Sessions (Rev. 1966, Issued: 05- 07-10, Effective: 01 -01-10, Implementation: 10- 04-10) When a beneficiary has reached 37 PR sessions, CWF shall reject the claims to the contractors if the KX modifier is not included on the claim line. Effective for claims with dates of service on or after January 1, 2010, Medicare contractors shall deny all claims (both professional and institutional claims) that exceed 36 PR sessions without a KX modifier included on the claim line. The following messages shall be used when Medicare contractors deny PR claims that exceed 36 sessions, without the KX modifier on the claim line: CARC 151: Payment adjusted because the payer deems the information submitted does not support this many/frequency of services. MSN 23.17: Medicare wont cover these services because they are not considered medically necessary . Spanish Version: M edicare no cubrir estos servicios porque no son considerados necesarios por razones mdicas. Contractors shall use Group Code PR (Patient Responsibility) assigning financial liability to the beneficiary, if a claim is received with a GA modifier indicating a signed ABN is on file. Contractors shall use Group Code CO (Contractual Obligation) assigning financial liability to the provider, if a claim is received with a GZ modifier indicating no signed ABN is on file. 140.4.2.5 Edits for PR Services Exceeding 72 Sessions (Rev. 12497; Issued: 02- 08-24; Effective: 01 -01-24; Implementation: 03 -12-24) Effective for claims with dates of service on and after January 1, 2010, through December 31, 2021, CWF shall reject PR claims that exceed 72 sessions. Medicare contractors shall deny PR claims that exceed 72 sessions regardless of whether the - KX modifier is submitted on the claim line. The following messages shall be used when Medicare contractors deny PR claims that exceed 72 sessions: CARC 119: Benefit maximum for this time period or occurrence has been reached. RARC N362: The number of days or units of service exceeds our acceptable maximum. MSN 20.5: These services cannot be paid because your benefits are exhausted at this time. Spanish Version: Estos servicios no pueden ser pagados porque sus beneficios se han agotado. Contractors shall use Group Code PR assigning financial liability to the beneficiary, if a claim is received with a GA modifier indicating a signed ABN is on file. Contractors shall use Group Code CO assigning financial liability to the provider, if a claim is received with a GZ modifier indicating no signed ABN is on file. Effective for claims with dates of service on and after January 1, 2022, Medicare Contractors shall deny PR claims that exceed 72 sessions only when the - KX modifier is not submitted on the claim line. 150 - Billing Requirements for Bariatric Surgery for Treatment of Morbid Obesity (Rev. 931, Issued: 04- 28-06, Effective: 02 -21-06, Implementation: 05- 30-06 Carrier/10-02-06 FI) 150.1 - General (Rev. 2841, Issued: 12- 23-13, Effective: 09 -24-13, Implementation: 12- 17-13)

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RARC N362: The number of days or units of service exceeds our acceptable maximum. MSN 20.5: These services cannot be paid because your benefits are exhausted at this time. Spanish Version: Estos servicios no pueden ser pagados porque sus beneficios se han agotado. Contractors shall use Group Code PR assigning financial liability to the beneficiary, if a claim is received with a GA modifier indicating a signed ABN is on file. Contractors shall use Group Code CO assigning financial liability to the provider, if a claim is received with a GZ modifier indicating no signed ABN is on file. Effective for claims with dates of service on and after January 1, 2022, Medicare Contractors shall deny PR claims that exceed 72 sessions only when the - KX modifier is not submitted on the claim line. 150 - Billing Requirements for Bariatric Surgery for Treatment of Morbid Obesity (Rev. 931, Issued: 04- 28-06, Effective: 02 -21-06, Implementation: 05- 30-06 Carrier/10-02-06 FI) 150.1 - General (Rev. 2841, Issued: 12- 23-13, Effective: 09 -24-13, Implementation: 12- 17-13) Bariatric Surgery for Treatment of Co -Morbid Conditions Related to Morbid Obesity Effective for services on or after February 21, 2006, Medicare has determined that the following bariatric surgery procedures are reasonable and necessary under certain conditions for the treatment of morbid obesity. The patient must have a body- mass index (BMI) 35, have at least one co -morbidity related to obesity, and have been previously unsuccessful with medical treatment for obesity. This medical information must be documented in the patient's medical record. In addition, the procedure must be perform ed at an approved facility. A list of approved facilities may be found at http://www.cms.gov/Medicare/Medicare -General -Information/MedicareApprovedFacilitie/Bariatric -Surgery.html Effective for services performed on and after February 12, 2009, Medicare has determined that Type 2 diabetes mellitus is a co -morbidity for purposes of processing bariatric surgery claims. Effective for dates of service on and after September 24, 2013, the Centers for Medicare & Medicaid Services (CMS) has removed the certified facility requirements for Bariatric Surgery for Treatment of Co-Morbid Conditions Related to Morbid Obesity. Please note the additional national coverage determinations related to bariatric surgery will be consolidated and subsumed into Publication 100-03, Chapter 1, section 100.1. These include sections 40.5, 100.8, 100.11 and 100.14. Open Roux- en-Y gastric bypass (RYGBP) Laparoscopic Roux- en-Y gastric bypass (RYGBP) Laparoscopic adjustable gastric banding (LAGB) Open biliopancreatic diversion with duodenal switch (BPD/DS) or gastric reduction duodenal switch (BPD/GRDS) Laparoscopic biliopancreatic diversion with duodenal switch (BPD/DS) or gastric reduction duodenal switch (BPD/GRDS) Laparoscopic sleeve gastrectomy (LSG) (Effective June 27, 2012, covered at Medicare Administrative Contractor (MAC) discretion. 150.2 - HCPCS Procedure Codes for Bariatric Surgery (Rev. 2641, Issued: 01- 29-13, Effective: 06-27-12, Implementation: 02-28-13) A. Covered HCPCS Procedure Codes For services on or after February 21, 2006, the following HCPCS procedure codes are covered for bariatric surgery: 43770 - Laparoscopy, surgical, gastric restrictive procedure; placement of adjustable gastric band (gastric band and subcutaneous port components). 43644 - Laparoscopy, surgical, gastric restrictive procedure; with gastric bypass and Roux-en-Y gastroenterostomy (roux limb 150 cm or less). 43645 - Laparoscopy with gastric bypass and small intestine reconstruction to limit absorption. (Do not report 43645 in conjunction with 49320, 43847.) 43845 - Gastric restrictive procedure with partial gastrectomy, pylorus -preserving duodenoileostomy and ileoieostomy (50 to 100 cm common channel) to limit absorption (biliopancreatic diversion with duodenal switch). 43846 - Gastric restrictive procedure, with gastric bypass for morbid obesity; with short limb (150 cm or less Roux- en-Y gastroenterostomy. (For greater than 150 cm, use 43847.) (For laparoscopic procedure, use 43644.) 43847 - With small intestine reconstruction to limit absorption. 43775- Laparoscopy, surgical, gastric restrictive procedure; longitudinal gastrectomy (i.e., sleeve gastrectomy) (Effective June 27, 2012, covered at contractors discretion.) B. Non-Covered HCPCS Procedure Codes For services on or after February 21, 2006, the following HCPCS procedure codes are non-covered for bariatric surgery: 43842 - Gastric restrictive procedure, without gastric bypass, for morbid obesity; vertical banded gastroplasty NOC code 43999 used to bill for: Laparoscopic vertical banded gastroplasty Open sleeve gastrectomy Laparoscopic sleeve gastrectomy (for contractor non -covered instances) Open adjustable gastric banding 150.3 - ICD Procedure Codes for Bariatric Surgery for Treatment of Co-Morbid Conditions Related to Morbid Obesity (A/MACs only) (Rev. 11021; Issued: 10- 01-21; Effective: 10-29- 21; Implementation: 10 -29-21) Covered ICD Procedure Codes For services on or after October 1, 2015, the following independent ICD -10 procedure codes are covered for bariatric surgery: 0D16479 Bypass Stomach to Duodenum with Autologous Tissue Substitute, Percutaneous Endoscopic Approach 0D1647A Bypass Stomach to Jejunum with Autologous Tissue Substitute, Percutaneous Endoscopic Approach 0D1647B Bypass Stomach to Ileum with Autologous Tissue Substitute, Percutaneous Endoscopic Approach 0D1647L Bypass Stomach to Transverse Colon with Autologous Tissue Substitute, Percutaneous Endoscopic Approach 0D164J9 Bypass Stomach to Duodenum with Synthetic Substitute, Percutaneous Endoscopic Approach 0D164JA Bypass Stomach to Jejunum with Synthetic Substitute, Percutaneous Endoscopic Approach 0D164JB Bypass Stomach to Ileum with Synthetic Substitute, Percutaneous Endoscopic Approach 0D164JL Bypass Stomach to Transverse Colon with Synthetic Substitute, Percutaneous Endoscopic Approach 0D164K9 Bypass Stomach to Duodenum with Non-autologous Tissue Substitute, Percutaneous Endoscopic Approach 0D164KA Bypass Stomach to Jejunum with Non- autologous Tissue Substitute, Percutaneous Endoscopic Approach 0D164KB Bypass Stomach to Ileum with Non- autologous Tissue Substitute, Percutaneous Endoscopic Approach 0D164KL Bypass Stomach to Transverse Colon with Non- autologous Tissue Substitute, Percutaneous Endoscopic Approach 0D164Z9 Bypass Stomach to Duodenum, Percutaneous Endoscopic Approach 0D164ZA Bypass Stomach to Jejunum, Percutaneous Endoscopic Approach 0D164ZB Bypass Stomach to Ileum, Percutaneous Endoscopic Approach 0D164ZL Bypass Stomach to Transverse Colon, Percutaneous Endoscopic Approach 0D16079 Bypass Stomach to Duodenum with Autologous Tissue Substitute, Open Approach 0D1607A Bypass Stomach to Jejunum with Autologous Tissue Substitute, Open Approach 0D1607B Bypass Stomach to Ileum with Autologous Tissue Substitute, Open Approach 0D1607L Bypass Stomach to Transverse Colon with Autologous Tissue Substitute, Open Approach 0D160J9 Bypass Stomach to Duodenum with Synthetic Substitute, Open Approach 0D160JA Bypass Stomach to Jejunum with Synthetic Substitute, Open Approach 0D160JB Bypass Stomach to Ileum with Synthetic Substitute, Open Approach 0D160JL Bypass Stomach to Transverse Colon with Synthetic Substitute, Open Approach 0D160K9 Bypass Stomach to Duodenum with Non- autologous Tissue Substitute, Open Approach 0D160KA Bypass Stomach to Jejunum with Non- autologous Tissue Substitute, Open Approach 0D160KB Bypass Stomach to Ileum with Non- autologous Tissue Substitute, Open Approach 0D160KL Bypass Stomach to Transverse Colon with Non- autologous Tissue Substitute, Open Approach 0D160Z9 Bypass Stomach to Duodenum, Open Approach 0D160ZA Bypass Stomach to Jejunum, Open Approach 0D160ZB Bypass Stomach to Ileum, Open Approach 0D160ZL Bypass Stomach to Transverse Colon, Open Approach 0D16879 Bypass Stomach to Duodenum with Autologous Tissue Substitute, Via Natural or Artificial Opening Endoscopic 0D1687A Bypass Stomach to Jejunum with Autologous Tissue Substitute, Via Natural or Artificial Opening Endoscopic 0D1687B Bypass Stomach to Ileum with Autologous Tissue Substitute, Via Natural or Artificial Opening Endoscopic 0D1687L Bypass Stomach to Transverse Colon with Autologous Tissue Substitute, Via Natural or Artificial Opening Endoscopic 0D168J9 Bypass Stomach to Duodenum with Synthetic Substitute, Via Natural or Artificial Opening Endoscopic 0D168JA Bypass Stomach to Jejunum with Synthetic Substitute, Via Natural or Artificial Opening Endoscopic 0D168JB Bypass Stomach to Ileum with Synthetic Substitute, Via Natural or Artificial Opening Endoscopic 0D168JL Bypass Stomach to Transverse Colon with Synthetic Substitute, Via Natural or Artificial Opening Endoscopic 0D168K9 Bypass Stomach to Duodenum with Non- autologous Tissue Substitute, Via Natural or Artificial Opening Endoscopic 0D168KA Bypass Stomach to Jejunum with Non -autologous Tissue Substitute, Via Natural or Artificial Opening Endoscopic 0D168KB Bypass Stomach to Ileum with Non- autologous Tissue Substitute, Via Natural or Artificial Opening Endoscopic 0D168KL Bypass Stomach to Transverse Colon with Non -autologous Tissue Substitute, Via Natural or Artificial Opening Endoscopic 0D168Z9 Bypass Stomach to Duodenum, Via Natural or Artificial Opening Endoscopic 0D168ZA Bypass Stomach to Jejunum, Via Natural or Artificial Opening Endoscopic 0D168ZB Bypass Stomach to Ileum, Via Natural or Artificial Opening Endoscopic 0D168ZL 0DV64CZ Bypass Stomach to Transverse Colon, Via Natural or Artificial Opening Endoscopic Restriction of Stomach with Extraluminal Device, Percutaneous Endoscopic Approach To describe either laparoscopic or open BPD with DS or GRDS, one code from each of the following three groups must be on the claim: Group 1: 0DB60Z3 Excision of Stomach, Open Approach, Vertical 0DB60ZZ Excision of Stomach, Open Approach 0DB63Z3 Excision of Stomach, Percutaneous Approach, Vertical 0DB63ZZ Excision of Stomach, Percutaneous Approach 0DB67Z3 Excision of Stomach, Via Natural or Artificial Opening, Vertical 0DB67ZZ Excision of Stomach, Via Natural or Artificial Opening 0DB68Z3 Excision of Stomach, Via Natural or Artificial Opening Endoscopic, Vertical Group 2: (Note: One code from A -C below is required for a correct equivalent)

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0D168ZB Bypass Stomach to Ileum, Via Natural or Artificial Opening Endoscopic 0D168ZL 0DV64CZ Bypass Stomach to Transverse Colon, Via Natural or Artificial Opening Endoscopic Restriction of Stomach with Extraluminal Device, Percutaneous Endoscopic Approach To describe either laparoscopic or open BPD with DS or GRDS, one code from each of the following three groups must be on the claim: Group 1: 0DB60Z3 Excision of Stomach, Open Approach, Vertical 0DB60ZZ Excision of Stomach, Open Approach 0DB63Z3 Excision of Stomach, Percutaneous Approach, Vertical 0DB63ZZ Excision of Stomach, Percutaneous Approach 0DB67Z3 Excision of Stomach, Via Natural or Artificial Opening, Vertical 0DB67ZZ Excision of Stomach, Via Natural or Artificial Opening 0DB68Z3 Excision of Stomach, Via Natural or Artificial Opening Endoscopic, Vertical Group 2: (Note: One code from A -C below is required for a correct equivalent) 0DB80ZZ Excision of Small Intestine, Open Approach A 0DB90ZZ Excision of Duodenum, Open Approach A 0DBB0ZZ Excision of Ileum, Open Approach A 0D160ZB Bypass Stomach to Ileum, Open Approach B 0F190Z3 Bypass Common Bile Duct to Duodenum, Open Approach C Group 3: 0D19079 Bypass Duodenum to Duodenum with Autologous Tissue Substitute, Open Approach 0D1907A Bypass Duodenum to Jejunum with Autologous Tissue Substitute, Open Approach 0D1907B Bypass Duodenum to Ileum with Autologous Tissue Substitute, Open Approach 0D190J9 Bypass Duodenum to Duodenum with Synthetic Substitute, Open Approach 0D190JA Bypass Duodenum to Jejunum with Synthetic Substitute, Open Approach 0D190JB Bypass Duodenum to Ileum with Synthetic Substitute, Open Approach 0D190K9 Bypass Duodenum to Duodenum with Non- autologous Tissue Substitute, Open Approach 0D190KA Bypass Duodenum to Jejunum with Non- autologous Tissue Substitute, Open Approach 0D190KB Bypass Duodenum to Ileum with Non- autologous Tissue Substitute, Open Approach 0D190Z9 Bypass Duodenum to Duodenum, Open Approach 0D190ZA Bypass Duodenum to Jejunum, Open Approach 0D190ZB Bypass Duodenum to Ileum, Open Approach 0D19479 Bypass Duodenum to Duodenum with Autologous Tissue Substitute, Percutaneous Endoscopic Approach 0D1947A Bypass Duodenum to Jejunum with Autologous Tissue Substitute, Percutaneous Endoscopic Approach 0D1947B Bypass Duodenum to Ileum with Autologous Tissue Substitute, Percutaneous Endoscopic Approach 0D194J9 Bypass Duodenum to Duodenum with Synthetic Substitute, Percutaneous Endoscopic Approach 0D194JA Bypass Duodenum to Jejunum with Synthetic Substitute, Percutaneous Endoscopic Approach 0D194JB Bypass Duodenum to Ileum with Synthetic Substitute, Percutaneous Endoscopic Approach 0D194K9 Bypass Duodenum to Duodenum with Non- autologous Tissue Substitute, Percutaneous Endoscopic Approach 0D194KA Bypass Duodenum to Jejunum with Non -autologous Tissue Substitute, Percutaneous Endoscopic Approach 0D194KB Bypass Duodenum to Ileum with Non- autologous Tissue Substitute, Percutaneous Endoscopic Approach 0D194Z9 Bypass Duodenum to Duodenum, Percutaneous Endoscopic Approach 0D194ZA Bypass Duodenum to Jejunum, Percutaneous Endoscopic Approach 0D194ZB Bypass Duodenum to Ileum, Percutaneous Endoscopic Approach 0D19879 Bypass Duodenum to Duodenum with Autologous Tissue Substitute, Via Natural or Artificial Opening Endoscopic 0D1987A Bypass Duodenum to Jejunum with Autologous Tissue Substitute, Via Natural or Artificial Opening Endoscopic 0D1987B Bypass Duodenum to Ileum with Autologous Tissue Substitute, Via Natural or Artificial Opening Endoscopic 0D198J9 Bypass Duodenum to Duodenum with Synthetic Substitute, Via Natural or Artificial Opening Endoscopic 0D198JA Bypass Duodenum to Jejunum with Synthetic Substitute, Via Natural or Artificial Opening Endoscopic 0D198JB Bypass Duodenum to Ileum with Synthetic Substitute, Via Natural or Artificial Opening Endoscopic 0D198K9 Bypass Duodenum to Duodenum with Non- autologous Tissue Substitute, Via Natural or Artificial Opening Endoscopic 0D198KA Bypass Duodenum to Jejunum with Non- autologous Tissue Substitute, Via Natural or Artificial Opening Endoscopic 0D198KB Bypass Duodenum to Ileum with Non- autologous Tissue Substitute, Via Natural or Artificial Opening Endoscopic 0D198Z9 Bypass Duodenum to Duodenum, Via Natural or Artificial Opening Endoscopic 0D198ZA Bypass Duodenum to Jejunum, Via Natural or Artificial Opening Endoscopic 0D198ZB Bypass Duodenum to Ileum, Via Natural or Artificial Opening Endoscopic 0D1A07A Bypass Jejunum to Jejunum with Autologous Tissue Substitute, Open Approach 0D1A07B Bypass Jejunum to Ileum with Autologous Tissue Substitute, Open Approach 0D1A0JA Bypass Jejunum to Jejunum with Synthetic Substitute, Open Approach 0D1A0JB Bypass Jejunum to Ileum with Synthetic Substitute, Open Approach 0D1A0KA Bypass Jejunum to Jejunum with Non- autologous Tissue Substitute, Open Approach 0D1A0KB Bypass Jejunum to Ileum with Non- autologous Tissue Substitute, Open Approach 0D1A0ZA Bypass Jejunum to Jejunum, Open Approach 0D1A0ZB Bypass Jejunum to Ileum, Open Approach 0D1A47A Bypass Jejunum to Jejunum with Autologous Tissue Substitute, Percutaneous Endoscopic Approach 0D1A47B Bypass Jejunum to Ileum with Autologous Tissue Substitute, Percutaneous Endoscopic Approach 0D1A4JA Bypass Jejunum to Jejunum with Synthetic Substitute, Percutaneous Endoscopic Approach 0D1A4JB Bypass Jejunum to Ileum with Synthetic Substitute, Percutaneous Endoscopic Approach 0D1A4KA Bypass Jejunum to Jejunum with Non- autologous Tissue Substitute, Percutaneous Endoscopic Approach 0D1A4KB Bypass Jejunum to Ileum with Non- autologous Tissue Substitute, Percutaneous Endoscopic Approach 0D1A4ZA Bypass Jejunum to Jejunum, Percutaneous Endoscopic Approach 0D1A4ZB Bypass Jejunum to Ileum, Percutaneous Endoscopic Approach 0D1A87A Bypass Jejunum to Jejunum with Autologous Tissue Substitute, Via Natural or Artificial Opening Endoscopic 0D1A87B Bypass Jejunum to Ileum with Autologous Tissue Substitute, Via Natural or Artificial Opening Endoscopic 0D1A8JA Bypass Jejunum to Jejunum with Synthetic Substitute, Via Natural or Artificial Opening Endoscopic 0D1A8JB Bypass Jejunum to Ileum with Synthetic Substitute, Via Natural or Artificial Opening Endoscopic 0D1A8KA Bypass Jejunum to Jejunum with Non- autologous Tissue Substitute, Via Natural or Artificial Opening Endoscopic 0D1A8KB Bypass Jejunum to Ileum with Non- autologous Tissue Substitute, Via Natural or Artificial Opening Endoscopic 0D1A8ZA Bypass Jejunum to Jejunum, Via Natural or Artificial Opening Endoscopic 0D1A8ZB Bypass Jejunum to Ileum, Via Natural or Artificial Opening Endoscopic 0D1A8ZH Bypass Jejunum to Cecum, Via Natural or Artificial Opening Endoscopic 0D1B07B Bypass Ileum to Ileum with Autologous Tissue Substitute, Open Approach 0D1B0JB Bypass Ileum to Ileum with Synthetic Substitute, Open Approach 0D1B0KB Bypass Ileum to Ileum with Non -autologous Tissue Substitute, Open Approach 0D1B0ZB Bypass Ileum to Ileum, Open Approach 0D1B47B Bypass Ileum to Ileum with Autologous Tissue Substitute, Percutaneous Endoscopic Approach 0D1B4JB Bypass Ileum to Ileum with Synthetic Substitute, Percutaneous Endoscopic Approach 0D1B4KB Bypass Ileum to Ileum with Non- autologous Tissue Substitute, Percutaneous Endoscopic Approach 0D1B4ZB Bypass Ileum to Ileum, Percutaneous Endoscopic Approach 0D1B87B Bypass Ileum to Ileum with Autologous Tissue Substitute, Via Natural or Artificial Opening Endoscopic 0D1B8JB Bypass Ileum to Ileum with Synthetic Substitute, Via Natural or Artificial Opening Endoscopic 0D1B8KB Bypass Ileum to Ileum with Non-autologous Tissue Substitute, Via Natural or Artificial Opening Endoscopic 0D1B8ZB Bypass Ileum to Ileum, Via Natural or Artificial Opening Endoscopic 0D1B8ZH Bypass Ileum to Cecum, Via Natural or Artificial Opening Endoscopic NOTE: There is no distinction between open and laparoscopic BPD with DS or GRDS for the inpatient setting. For either approach, one code from each of the above three groups must appear on the claim to be covered. Effective October 1, 2015, the following ICD-10 procedure code is covered for bariatric surgery at contractor discretion: 0DB64Z3 Excision of stomach, percutaneous endoscopic approach, vertical. 150.4 - ICD Diagnosis Codes for Bariatric Surgery (Rev. 11021; Issued: 10-01- 21; Effective: 10 -29-21; Implementation: 10 -29-21) For services on or after October 1, 2015, the following ICD-10 diagnosis code is covered for bariatric surgery if certain other conditions are met: E66.01 - Morbid (severe) obesity due to excess calories Effective for services performed on and after February 12, 2009, type 2 diabetes mellitus (T2DM) is considered a comorbid condition related to morbid obesity for covered bariatric surgery procedures in Medicare beneficiaries with a BMI 35. When T2DM is the comorbid condition related to morbid obesity, the claim must include a covered ICD procedure code, ICD diagnosis code E66.01 as a primary diagnosis, a covered ICD diagnosis code indicating T2DM as a secondary diagnosis, and an ICD diagnosis code indicating a BMI 35 as a secondary diagnosis. 150.5 - ICD Diagnosis Codes for BMI 35 (Rev. 11021; Issued: 10-01- 21; Effective: 10 -29-21; Implementation: 10-29-21) The following ICD- 10 diagnosis codes identify BMI 35:

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For services on or after October 1, 2015, the following ICD-10 diagnosis code is covered for bariatric surgery if certain other conditions are met: E66.01 - Morbid (severe) obesity due to excess calories Effective for services performed on and after February 12, 2009, type 2 diabetes mellitus (T2DM) is considered a comorbid condition related to morbid obesity for covered bariatric surgery procedures in Medicare beneficiaries with a BMI 35. When T2DM is the comorbid condition related to morbid obesity, the claim must include a covered ICD procedure code, ICD diagnosis code E66.01 as a primary diagnosis, a covered ICD diagnosis code indicating T2DM as a secondary diagnosis, and an ICD diagnosis code indicating a BMI 35 as a secondary diagnosis. 150.5 - ICD Diagnosis Codes for BMI 35 (Rev. 11021; Issued: 10-01- 21; Effective: 10 -29-21; Implementation: 10-29-21) The following ICD- 10 diagnosis codes identify BMI 35: Z68.35 - Body Mass Index 35.0-35.9, adult Z68.36 - Body Mass Index 36.0-36.9, adult Z68.37 - Body Mass Index 37.0-37.9, adult Z68.38 - Body Mass Index 38.0-38.9, adult Z68.39 - Body Mass Index 39.0-39.9, adult Z68.41 - Body Mass Index 40.0-44.9, adult Z68.42 - Body Mass Index 45.0-49.9, adult Z68.43 - Body Mass Index 50.0-59.9, adult Z68.44 - Body Mass Index 60.0-69.9, adult Z68.45 - Body Mass Index 70.0 and over, adult 150.5.1 ICD Codes for Type II Diabetes Mellitus Complication (Rev. 11021; Issued: 10-01- 21; Effective: 10 -29-21; Implementation: 10-29-21)

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E11.9 Type 2 diabetes mellitus without complications E13.9 Other specified diabetes mellitus without complications E11.65 Type 2 diabetes mellitus with hyperglycemia E13.10 Other specified diabetes mellitus with ketoacidosis without coma E11.69 Type 2 diabetes mellitus with other specified complication Note: E11.69 with E11.65 are a cluster BUT since each code on its own justifies the service, the combination is not required together for this policy. E11.00 Type 2 diabetes mellitus with hyperosmolarity without nonketotic hyperglycemic -hyperosmolar coma (NKHHC) E11.01 Type 2 diabetes mellitus with hyperosmolarity with coma E13.00 Other specified diabetes mellitus with hyperosmolarity without nonketotic hyperglycemic -hyperosmolar coma (NKHHC) E13.01 Other specified diabetes mellitus with hyperosmolarity with coma Note: E11.00 with E11.65 are a cluster BUT since each code on its own justifies the service, the combination is not required together for this policy. E11.641 Type 2 diabetes mellitus with hypoglycemia with coma E13.11 Other specified diabetes mellitus with ketoacidosis with coma E13.641 Other specified diabetes mellitus with hypoglycemia with coma Note: E11.01 with E11.65 are a cluster BUT since each code on its own justifies the service, the combination is not required together for this policy. E11.21 Type 2 diabetes mellitus with diabetic nephropathy E11.22 Type 2 diabetes mellitus with diabetic chronic kidney disease E11.29 Type 2 diabetes mellitus with other diabetic kidney complication E13.21 Other specified diabetes mellitus with diabetic nephropathy E13.22 Other specified diabetes mellitus with diabetic chronic kidney disease E13.29 Other specified diabetes mellitus with other diabetic kidney complication Note: E11.21 with E11.65 are a cluster BUT since each code on its own justifies the service, the combination is not required together for this policy. E11.3211 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye E11.3212 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye E11.3213 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral E11.3591 Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eye E11.3592 Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eye E11.3593 Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateral E11.37X1 Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, right eye E11.37X2 Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, left eye E11.37X3 Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral E11.3291 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye E11.3292 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye E11.3293 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral E11.3311 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye E11.3312 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye E11.3313 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral E11.3391 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye E11.3392 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, left eye E11.3393 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, bilateral E11.3411 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye E11.3412 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye E11.3413 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral E11.3491 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye E11.3492 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left eye E11.3493 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, bilateral E11.3511 Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye E11.3512 Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye E11.3513 Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral E11.3521 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye E11.3522 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye E11.3523 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral E11.3531 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye E11.3532 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye E11.3533 Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral E11.3591 Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eye E11.3592 Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eye E11.3593 Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateral E11.37X1 Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, right eye E11.37X2 Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, left eye E11.37X3 Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral E13.311 Other specified diabetes mellitus with unspecified diabetic retinopathy with macular edema E13.319 Other specified diabetes mellitus with unspecified diabetic retinopathy without macular edema E13.3211 Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye E13.3212 Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye E13.3213 Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral E13.3291 Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye E13.3292 Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye E13.3293 Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral E13.3311 Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye E13.3312 Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye E13.3313 Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral E13.3391 Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye E13.3392 Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, left eye E13.3393 Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, bilateral E13.3411 Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye E13.3412 Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye E13.3413 Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral E13.3491 Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye E13.3492 Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left eye E13.3493 Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, bilateral E13.3511 Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye E13.3512 Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye E13.3513 Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral E13.3521 Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye E13.3522 Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye E13.3523 Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral E13.3531 Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye E13.3532 Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye E13.3533 Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral E13.3541 Other specified diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, right eye E13.3542 Other specified diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye E13.3543 Other specified diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral E13.3551 Other specified diabetes mellitus with stable proliferative diabetic retinopathy, right eye E13.3552 Other specified diabetes mellitus with stable proliferative diabetic retinopathy, left eye E13.3553 Other specified diabetes mellitus with stable proliferative diabetic retinopathy, bilateral E13.3591 Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eye E13.3592 Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eye E13.3593 Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateral E13.36 Other specified diabetes mellitus with diabetic cataract E13.39 Other specified

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clm104c32.pdf

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Other specified diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, right eye E13.3542 Other specified diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye E13.3543 Other specified diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral E13.3551 Other specified diabetes mellitus with stable proliferative diabetic retinopathy, right eye E13.3552 Other specified diabetes mellitus with stable proliferative diabetic retinopathy, left eye E13.3553 Other specified diabetes mellitus with stable proliferative diabetic retinopathy, bilateral E13.3591 Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eye E13.3592 Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eye E13.3593 Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateral E13.36 Other specified diabetes mellitus with diabetic cataract E13.39 Other specified diabetes mellitus with other diabetic ophthalmic complication E11.311 Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema OR E11.319 Type 2 diabetes mellitus with unspecified diabetic retinopathy without macular edema OR E11.36 Type 2 diabetes mellitus with diabetic cataract OR E11.39 Type 2 diabetes mellitus with other diabetic ophthalmic complication AND Note: E11.39 with E11.65 are a cluster BUT since each code on its own justifies the service, the combination is not required together for this policy E13.37X1 Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, right eye E13.37X2 Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, left eye E13.37X3 Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral E11.40 Type 2 diabetes mellitus with diabetic neuropathy, unspecified E11.41 Type 2 diabetes mellitus with diabetic mononeuropathy E11.42 Type 2 diabetes mellitus with diabetic polyneuropathy E11.43 Type 2 diabetes mellitus with diabetic autonomic (poly)neuropathy E11.44 Type 2 diabetes mellitus with diabetic amyotrophy E11.49 Type 2 diabetes mellitus with other diabetic neurological complication E11.610 Type 2 diabetes mellitus with diabetic neuropathic arthropathy E13.40 Other specified diabetes mellitus with diabetic neuropathy, unspecified E13.41 Other specified diabetes mellitus with diabetic mononeuropathy E13.42 Other specified diabetes mellitus with diabetic polyneuropathy E13.43 Other specified diabetes mellitus with diabetic autonomic (poly)neuropathy E13.44 Other specified diabetes mellitus with diabetic amyotrophy E13.49 Other specified diabetes mellitus with other diabetic neurological complication E13.610 Other specified diabetes mellitus with diabetic neuropathic arthropathy Note: E11.40 with E11.65 are a cluster BUT since each code on its own justifies the service, the combination is not required together for this policy . E11.51 Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene E11.52 Type 2 diabetes mellitus with diabetic peripheral angiopathy with gangrene E11.59 Type 2 diabetes mellitus with other circulatory complications E13.51 Other specified diabetes mellitus with diabetic peripheral angiopathy without gangrene E13.52 Other specified diabetes mellitus with diabetic peripheral angiopathy with gangrene E13.59 Other specified diabetes mellitus with other circulatory complications Note: E11.51 with E11.65 are a cluster BUT since each code on its own justifies the service, the combination is not required together for this policy. E11.618 Type 2 diabetes mellitus with other diabetic arthropathy E11.620 Type 2 diabetes mellitus with diabetic dermatitis E11.621 Type 2 diabetes mellitus with foot ulcer E11.622 Type 2 diabetes mellitus with other skin ulcer E11.628 Type 2 diabetes mellitus with other skin complications E11.630 Type 2 diabetes mellitus with periodontal disease E11.638 Type 2 diabetes mellitus with other oral complications E11.649 Type 2 diabetes mellitus with hypoglycemia without coma E13.618 Other specified diabetes mellitus with other diabetic arthropathy E13.620 Other specified diabetes mellitus with diabetic dermatitis E13.621 Other specified diabetes mellitus with foot ulcer E13.622 Other specified diabetes mellitus with other skin ulcer E13.628 Other specified diabetes mellitus with other skin complications E13.630 Other specified diabetes mellitus with periodontal disease E13.638 Other specified diabetes mellitus with other oral complications E13.649 Other specified diabetes mellitus with hypoglycemia without coma E13.65 Other specified diabetes mellitus with hyperglycemia E13.69 Other specified diabetes mellitus with other specified complication Note: E11.69 with E11.65 are a cluster BUT since each code on its own justifies the service, the combination is not required together for this policy. E13.8 Other specified diabetes mellitus with unspecified complications E11.8 Type 2 diabetes mellitus with unspecified complications

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Note: E11.8 with E11.65 are a cluster BUT since each code on its own justifies the service, the combination is not required together for this policy. 150.6 - Claims Guidance for Payment (Rev. 11021; Issued: 10- 01-21; Effective: 10 -29-21; Implementation: 10 -29-21) Covered Bariatric Surgery Procedures for Treatment of Co -Morbid Conditions Related to Morbid Obesity Contractors shall process covered bariatric surgery claims as follows: C. Identify bariatric surgery claims. Contractors identify inpatient bariatric surgery claims by the presence of ICD -10 diagnosis code E66.01as the primary diagnosis (for morbid obesity) and one of the covered ICD -10 procedure codes listed in 150.3. Contractors identify practitioner bariatric surgery claims by the presence of ICD -10 diagnosis code E66.01 as the primary diagnosis (for morbid obesity) and one of the covered HCPCS procedure codes listed in 150.2. D. Perform facility certification validation for all bariatric surgery claims on a pre -pay basis up to and including date of service September 23, 2013. A list of approved facilities are found at the link noted in section 150.1, section A, above. E. Review bariatric surgery claims data and determine whether a pre- or post -pay sample of bariatric surgery claims need further review to assure that the beneficiary has a BMI 35 (Z68.35- Z68.45) (see ICD -10 equivalents above in section 150.5), and at least one co -morbidity related to obesity. The A/B MAC medical director may define the appropriate method for addressing the obesity -related co-morbid requirement. Effective for dates of service on and after September 24, 2013, CMS has removed the certified facility requirements for Bariatric Surgery for Treatment of Co -Morbid Conditions Related to Morbid Obesity. NOTE: If ICD -10 diagnosis code E66.01 is present, but a covered procedure code (listed in 150.2 or 150.3) is/are not present, the claim is not for bariatric surgery and should be processed under normal procedures. NOTE: If ICD -10 diagnosis code E66.01 is present, but a covered procedure code (listed in 150.2 or 150.3) is/are not present, the claim is not for bariatric surgery and should be processed under normal procedures. 150.7 - Medicare Summary Notices (MSNs) and Claim Adjustment Reason Codes (Rev. 11021; Issued: 10- 01-21; Effective: 10 -29-21; Implementation: 10 -29-21) When rejecting/denying claims because bariatric surgery procedures were performed in an unapproved facility use: MSN 16.2 - "This service cannot be paid when provided in this location/facility." Claim Adjustment Reason Code 58 - "Payment adjusted because treatment was deemed by the payer to have been rendered in an inappropriate or invalid place of service." Remittance Advice Remark Code 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. When rejecting/denying claims for non- covered bariatric surgery procedures use: MSN16.10 - Medicare does not pay for this item or service. Claim Adjustment Reason Code 50 - "These are non -covered services because this is not deemed a medical necessity by the payer." Remittance Advice Remark Code 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. When rejecting/denying claims for covered bariatric surgery procedures because the patient did not meet the conditions for coverage use: MSN 15.4 - The information provided does not support the need for this service or item. Claim Adjustment Reason Code 167 - "This (these) diagnosis(es) is (are) not covered Remittance Advice Remark Code 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. Group Code CO Contractual Obligation In addition to the codes listed above, afford appeal rights to all denied parties. 150.8 - A/MAC Billing Requirements (Rev. 2841, Issued: 12- 23-13, Effective: 09 -24-13, Implementation: 12- 17-13) The A/MAC billing requirements will pay for bariatric surgery only when the services are submitted on the following type of bill (TOB): 11X. Type of facility and setting determines the basis of payment: For services performed in Indian Health Services inpatient hospitals, TOB 11X under the inpatient prospective payment system (IPPS) is based on the diagnosis -related group (DRG). For services performed in inpatient hospitals, TOB 11X under IPPS is based on the DRG. For services performed in IHS critical access hospitals (CAHs), TOB 11X, payment is based on 101% facility specific per diem rate. For services performed in CAH inpatient hospitals, TOB 11X, payment is based on 101% of reasonable cost. 150.9 - Advance Beneficiary Notice and HINN Information (Rev. 1233, Issued: 04- 27-07, Effective: 02 -21-06, Implementation: 05- 29-07) Physicians must be advised that the physician is liable for charges if the surgery is performed in an unapproved facility, unless the beneficiary was informed that he or she would be financially responsible prior to performance for the procedure. The provi der must have the beneficiary sign an advance beneficiary notice (ABN) if the bariatric surgery is performed in an unapproved facility. Note that the ABN is the appropriate notice for Part B services. The HINN model language should be adapted to this situation in the sections addressing: description of the care at issue if the surgery is performed on an inpatient basis, in an unapproved facility, to avoid being liable, the provider must issue a HINN. Other content requirements of HINN still apply. Use the HINN letter most appropriate to the overall situation. 160 PTA for Implanting the Carotid Stent (Rev. 1042, Issued: 08- 25-06; Effective: 03 -17-05; Implementation: 10 -02-06) 160.1 Category B Investigational Device Exemption (IDE) Study Coverage (Rev. 1925; Issued: 03- 05-10; Effective Date: 12 -09-09; Implementation Date: 04- 05-10) Effective July 1, 2001, Medicare covers percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stent placement when furnished in accordance with the Food and Drug Administration (FDA) protocols governing Category B Investigationa l Device Exemption (IDE) studies. The billing for this procedure is based upon how the service is delivered. There are several CPT codes that may be billed depending upon how the procedure is performed. Contractor medical directors should consider what provider education information is nee ded to assist providers on the billing for this service. Contractors must review their local coverage determinations to ensure that payment is provided for claims for PTA in an FDA- approved clinical study and deny any claims for services for PTA of the carotid artery when provided outside of an FDA -approved clinical study. As a requirement for Category B IDE coverage, providers must bill a six- digit IDE Number that begins with a G (i.e., G123456). To identify the line as an IDE line, institutional providers must bill this IDE Number on a 0624 Revenue Code line while practi tioners must bill this IDE Number along with a Q0 modifier. 160.2 Post-Approval Study Coverage (Rev. 1925; Issued: 03- 05-10; Effective Date: 12 -09-09; Implementation Date: 04- 05-10) Effective October 12, 2004, Medicare covers PTA of the carotid artery concurrent with the placement of an FDA -approved carotid stent and an FDA -approved or cleared embolic protection device (effective December 9, 2009) for an FDA -approved indication when furnished in accordance with FDA -approved protocols governing post -approval studies. Billing post -approval studies is similar to normal Category B IDE billing procedures, except that under post -approval coverage, providers must bill the Pre -Market Approval (PMA) number assigned to the stent system by the FDA. PMA numbers are like typical IDE Numbers in that they have six -digits, but they begin with a P (i.e., P123456) instead of a G. 160.2.1 Carotid Artery Stenting (CAS) for Post -Approval Studies (Rev. 11021; Issued: 10- 01-21; Effective: 10 -29-21; Implementation: 10 -29-21) A. Background As the post -approval studies began to end, CMS received requests to extend coverage for the post -approval studies. CMS has reviewed the extension requests and has determined that patients participating in post -approval extension studies are also included in the currently covered population of patients participating in FDA -approved post -approval studies. B. Policy To grant approval for post -approval studies, the FDA reviews each study protocol. Once approval is granted, the FDA issues a formal approval letter to the study sponsor. Extensions of post -approval studies are not subject to approval by the FDA because they surpass the post -approval study requirements identified in the conditions of approval for post -approval studies. Since the FDA cannot approve these extension studies, i ndividual Post -Market Approval (PMA) numbers cannot be issued to separately identify each study. Currently, in order to receive reimbursement for procedures performed as part of a carotid artery stenting post -approval study, providers must include the FDA -issued PMA number on each claim to indicate participation in a specific study. CMS has determined that all extension studies must be reviewed by the FDA. The FDA will issue an acknowledgement letter stating that the extension study is scientifically valid and will generate clinically relevant post -market data. Upon receipt of this letter and review of the extension study protocol, CMS will issue a letter to the study sponsor indicating that the study under review will be covered by Medicare. Since an individual PMA number cannot be assigned by the FDA to each extension study, these studies will use the PMA number assigned to the original FDA -approved post -approval study (i.e., CAPTURE 2 shall use the PMA number assigned to CAPTURE 1). C. Billing In order to receive Medicare coverage for patients participating in post -approval extension studies, providers shall submit both the FDA acknowledgement letter and the CMS letter providing coverage for the extension study to their contractor. Additionally, providers shall submit any other materials contractors would require for FDA -approved post - approval studies. In response, contractors will issue a letter assigning an effective date for each facilitys participation in the extension study. Providers may bill for procedures performed in the extension study for dates of service on and after the assigned effective d ate. Providers billing A/B MACs (A) must bill using the most current ICD-10-CM is applicable, Indications for PTA of the Carotid Artery Concurrent with Stenting (must bill one of these primary codes to meet coverage under 20.7B2, 20.7B3, 20.7B4)

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C. Billing In order to receive Medicare coverage for patients participating in post -approval extension studies, providers shall submit both the FDA acknowledgement letter and the CMS letter providing coverage for the extension study to their contractor. Additionally, providers shall submit any other materials contractors would require for FDA -approved post - approval studies. In response, contractors will issue a letter assigning an effective date for each facilitys participation in the extension study. Providers may bill for procedures performed in the extension study for dates of service on and after the assigned effective d ate. Providers billing A/B MACs (A) must bill using the most current ICD-10-CM is applicable, Indications for PTA of the Carotid Artery Concurrent with Stenting (must bill one of these primary codes to meet coverage under 20.7B2, 20.7B3, 20.7B4) I63.031 Cerebral infarction due to thrombosis of right carotid artery I63.032 Cerebral infarction due to thrombosis of left carotid artery I63.033 Cerebral infarction due to thrombosis of bilateral carotid arteries I63.131 Cerebral infarction due to embolism of right carotid artery I63.132 Cerebral infarction due to embolism of left carotid artery I63.133 Cerebral infarction due to embolism of bilateral carotid arteries I63.231 Cerebral infarction due to unspecified occlusion or stenosis of right carotid arteries I63.232 Cerebral infarction due to unspecified occlusion or stenosis of left carotid arteries I63.233 Cerebral infarction due to unspecified occlusion or stenosis of bilateral carotid arteries I65.21 Occlusion and stenosis of right carotid artery I65.22 Occlusion and stenosis of left carotid artery I65.23 Occlusion and stenosis of bilateral carotid arteries ICD-10-PCS codes may be used.

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037G34Z Dilation of Intracranial Artery with Drug -eluting Intraluminal Device, Percutaneous Approach 037G35Z Dilation of Intracranial Artery with Two Drug -eluting Intraluminal Devices, Percutaneous Appro 037G36Z Dilation of Intracranial Artery with Three Drug -eluting Intraluminal Devices, Percutaneous Appr 037G37Z Dilation of Intracranial Artery with Four or More Drug -eluting Intraluminal Devices, Percutaneo Approach 037G3DZ Dilation of Intracranial Artery with Intraluminal Device, Percutaneous Approach 037G3EZ Dilation of Intracranial Artery with Two Intraluminal Devices, Percutaneous Approach 037G3FZ Dilation of Intracranial Artery with Three Intraluminal Devices, Percutaneous Approach 037G3GZ Dilation of Intracranial Artery with Four or More Intraluminal Devices, Percutaneous Approach 037G44Z Dilation of Intracranial Artery with Drug -eluting Intraluminal Device, Percutaneous Endoscopic Approach 037G45Z Dilation of Intracranial Artery with Two Drug -eluting Intraluminal Devices, Percutaneous Endos Approach 037G46Z Dilation of Intracranial Artery with Three Drug -eluting Intraluminal Devices, Percutaneous Endoscopic Approach 037G47Z Dilation of Intracranial Artery with Four or More Drug -eluting Intraluminal Devices, Percutaneo Endoscopic Approach 037G4DZ Dilation of Intracranial Artery with Intraluminal Device, Percutaneous Endoscopic Approach 037G4EZ Dilation of Intracranial Artery with Two Intraluminal Devices, Percutaneous Endoscopic Approa 037G4FZ Dilation of Intracranial Artery with Three Intraluminal Devices, Percutaneous Endoscopic Appro 037G4GZ Dilation of Intracranial Artery with Four or More Intraluminal Devices, Percutaneous Endoscopic Approach 037H34Z Dilation of Right Common Carotid Artery with Drug -eluting Intraluminal Device, Percutaneous Approach 037H35Z Dilation of Right Common Carotid Artery with Two Drug -eluting Intraluminal Devices, Percutan Approach 037H36Z Dilation of Right Common Carotid Artery with Three Drug -eluting Intraluminal Devices, Percutaneous Approach 037H37Z Dilation of Right Common Carotid Artery with Four or More Drug -eluting Intraluminal Devices, Percutaneous Approach 037H3DZ Dilation of Right Common Carotid Artery with Intraluminal Device, Percutaneous Approach 037H3EZ Dilation of Right Common Carotid Artery with Two Intraluminal Devices, Percutaneous Approa 037H3FZ Dilation of Right Common Carotid Artery with Three Intraluminal Devices, Percutaneous Appro 037H3GZ Dilation of Right Common Carotid Artery with Four or More Intraluminal Devices, Percutaneous Approach 037H44Z Dilation of Right Common Carotid Artery with Drug -eluting Intraluminal Device, Percutaneous Endoscopic Approach 037H45Z Dilation of Right Common Carotid Artery with Two Drug -eluting Intraluminal Devices, Percutan Endoscopic Approach 037H46Z Dilation of Right Common Carotid Artery with Three Drug -eluting Intraluminal Devices, Percutaneous Endoscopic Approach 037H47Z Dilation of Right Common Carotid Artery with Four or More Drug -eluting Intraluminal Devices, Percutaneous Endoscopic Approach 037H4DZ Dilation of Right Common Carotid Artery with Intraluminal Device, Percutaneous Endoscopic Approach 037H4EZ Dilation of Right Common Carotid Artery with Two Intraluminal Devices, Percutaneous Endosc Approach 037H4FZ Dilation of Right Common Carotid Artery with Three Intraluminal Devices, Percutaneous Endos Approach 037H4GZ Dilation of Right Common Carotid Artery with Four or More Intraluminal Devices, Percutaneous Endoscopic Approach 037J34Z Dilation of Left Common Carotid Artery with Drug -eluting Intraluminal Device, Percutaneous Approach 037J35Z Dilation of Left Common Carotid Artery with Two Drug -eluting Intraluminal Devices, Percutane Approach 037J36Z Dilation of Left Common Carotid Artery with Three Drug -eluting Intraluminal Devices, Percutan Approach 037J37Z Dilation of Left Common Carotid Artery with Four or More Drug -eluting Intraluminal Devices, Percutaneous Approach 037J3DZ Dilation of Left Common Carotid Artery with Intraluminal Device, Percutaneous Approach 037J3EZ Dilation of Left Common Carotid Artery with Two Intraluminal Devices, Percutaneous Approach 037J3FZ Dilation of Left Common Carotid Artery with Three Intraluminal Devices, Percutaneous Approa 037J3GZ Dilation of Left Common Carotid Artery with Four or More Intraluminal Devices, Percutaneous Approach 037J44Z Dilation of Left Common Carotid Artery with Drug -eluting Intraluminal Device, Percutaneous Endoscopic Approach 037J45Z Dilation of Left Common Carotid Artery with Two Drug -eluting Intraluminal Devices, Percutane Endoscopic Approach 037J46Z Dilation of Left Common Carotid Artery with Three Drug -eluting Intraluminal Devices, Percutan Endoscopic Approach 037J47Z Dilation of Left Common Carotid Artery with Four or More Drug -eluting Intraluminal Devices, Percutaneous Endoscopic Approach 037J4DZ Dilation of Left Common Carotid Artery with Intraluminal Device, Percutaneous Endoscopic Approach 037J4EZ Dilation of Left Common Carotid Artery with Two Intraluminal Devices, Percutaneous Endoscop Approach 037J4FZ Dilation of Left Common Carotid Artery with Three Intraluminal Devices, Percutaneous Endosco Approach 037J4GZ Dilation of Left Common Carotid Artery with Four or More Intraluminal Devices, Percutaneous Endoscopic Approach 037K34Z Dilation of Right Internal Carotid Artery with Drug -eluting Intraluminal Device, Percutaneous Approach 037K35Z Dilation of Right Internal Carotid Artery with Two Drug -eluting Intraluminal Devices, Percutane Approach 037K36Z Dilation of Right Internal Carotid Artery with Three Drug -eluting Intraluminal Devices, Percutan Approach 037K37Z Dilation of Right Internal Carotid Artery with Four or More Drug -eluting Intraluminal Devices, Percutaneous Approach 037K3DZ Dilation of Right Internal Carotid Artery with Intraluminal Device, Percutaneous Approach 037K3EZ Dilation of Right Internal Carotid Artery with Two Intraluminal Devices, Percutaneous Approach 037K3FZ Dilation of Right Internal Carotid Artery with Three Intraluminal Devices, Percutaneous Approac 037K3GZ Dilation of Right Internal Carotid Artery with Four or More Intraluminal Devices, Percutaneous Approach 037K44Z Dilation of Right Internal Carotid Artery with Drug -eluting Intraluminal Device, Percutaneous Endoscopic Approach 037K45Z Dilation of Right Internal Carotid Artery with Two Drug -eluting Intraluminal Devices, Percutane Endoscopic Approach 037K46Z Dilation of Right Internal Carotid Artery with Three Drug -eluting Intraluminal Devices, Percutan Endoscopic Approach 037K47Z Dilation of Right Internal Carotid Artery with Four or More Drug -eluting Intraluminal Devices, Percutaneous Endoscopic Approach 037K4DZ Dilation of Right Internal Carotid Artery with Intraluminal Device, Percutaneous Endoscopic Approach 037K4EZ Dilation of Right Internal Carotid Artery with Two Intraluminal Devices, Percutaneous Endoscop Approach 037K4FZ Dilation of Right Internal Carotid Artery with Three Intraluminal Devices, Percutaneous Endosco Approach 037K4GZ Dilation of Right Internal Carotid Artery with Four or More Intraluminal Devices, Percutaneous Endoscopic Approach 037L34Z Dilation of Left Internal Carotid Artery with Drug -eluting Intraluminal Device, Percutaneous Approach 037L35Z Dilation of Left Internal Carotid Artery with Two Drug -eluting Intraluminal Devices, Percutaneo Approach 037L36Z Dilation of Left Internal Carotid Artery with Three Drug -eluting Intraluminal Devices, Percutane Approach 037L37Z Dilation of Left Internal Carotid Artery with Four or More Drug -eluting Intraluminal Devices, Percutaneous Approach 037L3DZ Dilation of Left Internal Carotid Artery with Intraluminal Device, Percutaneous Approach 037L3EZ Dilation of Left Internal Carotid Artery with Two Intraluminal Devices, Percutaneous Approach 037L3FZ Dilation of Left Internal Carotid Artery with Three Intraluminal Devices, Percutaneous Approach 037L3GZ Dilation of Left Internal Carotid Artery with Four or More Intraluminal Devices, Percutaneous Approach 037L44Z Dilation of Left Internal Carotid Artery with Drug -eluting Intraluminal Device, Percutaneous Endoscopic Approach 037L45Z Dilation of Left Internal Carotid Artery with Two Drug -eluting Intraluminal Devices, Percutaneo Endoscopic Approach 037L46Z Dilation of Left Internal Carotid Artery with Three Drug -eluting Intraluminal Devices, Percutane Endoscopic Approach 037L47Z Dilation of Left Internal Carotid Artery with Four or More Drug -eluting Intraluminal Devices, Percutaneous Endoscopic Approach 037L4DZ Dilation of Left Internal Carotid Artery with Intraluminal Device, Percutaneous Endoscopic App 037L4EZ Dilation of Left Internal Carotid Artery with Two Intraluminal Devices, Percutaneous Endoscopi Approach 037L4FZ Dilation of Left Internal Carotid Artery with Three Intraluminal Devices, Percutaneous Endoscop Approach 037L4GZ Dilation of Left Internal Carotid Artery with Four or More Intraluminal Devices, Percutaneous Endoscopic Approach 037M34Z Dilation of Right External Carotid Artery with Drug -eluting Intraluminal Device, Percutaneous Approach 037M35Z Dilation of Right External Carotid Artery with Two Drug -eluting Intraluminal Devices, Percutan Approach 037M36Z Dilation of Right External Carotid Artery with Three Drug -eluting Intraluminal Devices, Percutaneous Approach 037M37Z Dilation of Right External Carotid Artery with Four or More Drug -eluting Intraluminal Devices, Percutaneous Approach 037M3DZ Dilation of Right External Carotid Artery with Intraluminal Device, Percutaneous Approach 037M3EZ Dilation of Right External Carotid Artery with Two Intraluminal Devices, Percutaneous Approac 037M3FZ Dilation of Right External Carotid Artery with Three Intraluminal Devices, Percutaneous Approa 037M3GZ Dilation of Right External Carotid Artery with Four or More Intraluminal Devices, Percutaneous Approach 037M44Z Dilation of

(Medicare Claims Processing Manual)

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of Left Internal Carotid Artery with Four or More Intraluminal Devices, Percutaneous Endoscopic Approach 037M34Z Dilation of Right External Carotid Artery with Drug -eluting Intraluminal Device, Percutaneous Approach 037M35Z Dilation of Right External Carotid Artery with Two Drug -eluting Intraluminal Devices, Percutan Approach 037M36Z Dilation of Right External Carotid Artery with Three Drug -eluting Intraluminal Devices, Percutaneous Approach 037M37Z Dilation of Right External Carotid Artery with Four or More Drug -eluting Intraluminal Devices, Percutaneous Approach 037M3DZ Dilation of Right External Carotid Artery with Intraluminal Device, Percutaneous Approach 037M3EZ Dilation of Right External Carotid Artery with Two Intraluminal Devices, Percutaneous Approac 037M3FZ Dilation of Right External Carotid Artery with Three Intraluminal Devices, Percutaneous Approa 037M3GZ Dilation of Right External Carotid Artery with Four or More Intraluminal Devices, Percutaneous Approach 037M44Z Dilation of Right External Carotid Artery with Drug -eluting Intraluminal Device, Percutaneous Endoscopic Approach 037M45Z Dilation of Right External Carotid Artery with Two Drug -eluting Intraluminal Devices, Percutan Endoscopic Approach 037M46Z Dilation of Right External Carotid Artery with Three Drug -eluting Intraluminal Devices, Percutaneous Endoscopic Approach 037M47Z Dilation of Right External Carotid Artery with Four or More Drug -eluting Intraluminal Devices, Percutaneous Endoscopic Approach 037M4DZ Dilation of Right External Carotid Artery with Intraluminal Device, Percutaneous Endoscopic Approach 037M4EZ Dilation of Right External Carotid Artery with Two Intraluminal Devices, Percutaneous Endosco Approach 037M4FZ Dilation of Right External Carotid Artery with Three Intraluminal Devices, Percutaneous Endosc Approach 037M4GZ Dilation of Right External Carotid Artery with Four or More Intraluminal Devices, Percutaneous Endoscopic Approach 037N34Z Dilation of Left External Carotid Artery with Drug -eluting Intraluminal Device, Percutaneous Approach 037N35Z Dilation of Left External Carotid Artery with Two Drug -eluting Intraluminal Devices, Percutaneo Approach 037N36Z Dilation of Left External Carotid Artery with Three Drug -eluting Intraluminal Devices, Percutane Approach 037N37Z Dilation of Left External Carotid Artery with Four or More Drug -eluting Intraluminal Devices, Percutaneous Approach 037N3DZ Dilation of Left External Carotid Artery with Intraluminal Device, Percutaneous Approach 037N3EZ Dilation of Left External Carotid Artery with Two Intraluminal Devices, Percutaneous Approach 037N3FZ Dilation of Left External Carotid Artery with Three Intraluminal Devices, Percutaneous Approac 037N3GZ Dilation of Left External Carotid Artery with Four or More Intraluminal Devices, Percutaneous Approach 037N44Z Dilation of Left External Carotid Artery with Drug -eluting Intraluminal Device, Percutaneous Endoscopic Approach 037N45Z Dilation of Left External Carotid Artery with Two Drug -eluting Intraluminal Devices, Percutaneo Endoscopic Approach 037N46Z Dilation of Left External Carotid Artery with Three Drug -eluting Intraluminal Devices, Percutan Endoscopic Approach 037N47Z Dilation of Left External Carotid Artery with Four or More Drug -eluting Intraluminal Devices, Percutaneous Endoscopic Approach 037N4DZ Dilation of Left External Carotid Artery with Intraluminal Device, Percutaneous Endoscopic Approach 037N4EZ Dilation of Left External Carotid Artery with Two Intraluminal Devices, Percutaneous Endoscop Approach 037N4FZ Dilation of Left External Carotid Artery with Three Intraluminal Devices, Percutaneous Endosco Approach 037N4GZ Dilation of Left External Carotid Artery with Four or More Intraluminal Devices, Percutaneous Endoscopic Approach

(Medicare Claims Processing Manual)

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160.3 Carotid Artery Stenting (CAS) With Embolic Protection Coverage (Rev. 1925; Issued: 03- 05-10; Effective Date: 12 -09-09; Implementation Date: 04 -05-10) Effective March 17, 2005, Medicare covers PTA of the carotid artery concurrent with the placement of an FDA -approved carotid stent with embolic protection under specific patient indications found in Pub. 100- 03, Medicare National Coverage Determinations Manual, part 1, section 20.7. Coverage is limited to procedures performed using FDA -approved CAS systems and FDA -approved or cleared (effective December 9, 2009) embolic protection devices (EPDs). If deployment of the EPD is not technically possible, and not performed, then the procedure is not covered. In addition to the specific patient indications, CMS determined that CAS with embolic protection is reasonable and necessary only if performed in facilities that have been determined to be competent in performing the evaluation, procedure, and follow -up ne cessary to ensure optimal patient outcomes. CMS created a list of minimum standards modeled in part on professional society statements on competency. All facilities must at least meet CMSs standards in order to receive coverage for CAS for high -risk pat ients. Facilities must recertify every 2 years in order to maintain coverage of CAS procedures. 160.4 510k Post -Approval Extension Studies using 510k -Cleared Embolic Protection Devices during Carotid Artery Stenting (CAS) Procedures (Rev. 11021; Issued: 10- 01-21; Effective: 10 -29-21; Implementation: 10 -29-21) A. Background As explained above in section 160.2, the Centers for Medicare & Medicaid Services (CMS) issued instructions in 2004 for processing claims for carotid artery stenting (CAS) procedures performed in Food and Drug Administration (FDA) -approved post -approval st udies. As the post -approval studies began to end, CMS received requests to extend coverage for the post -approval studies. As explained above in section 160.2.1, CMS reviewed the extension requests and determined that patients participating in post -approval extension studies were also included in the covered population of patients participating in FDA -approved post-approval studies. Recently, the FDA issued 510k approvals for proximal embolic protection devices (EPDs) which are utilized in CAS procedures. Utilization of an EPD is required in the Percutaneous Transluminal Angioplasty (PTA) national coverage determination (NCD) at Pub. 100- 03, chapter 1, section 20.7. However the 510k process does not involve a post - approval study requirement as traditional FDA marketing approvals require. CMS received requests to include patients participating in studies following the FDA 510k approval of these devices under NCD 20.7. CMS subsequently determined that these patients, similar to patients covered in traditional post -approval extension studies, are eligible for coverage under the current coverage policy at NCD 20.7. The FDA does not require devices approved through the 510k process to undergo further study following clearance. As such, 510k post -approval extension studies are neither required by the FDA or subject to FDA approval. However, for the purposes of study re view, the FDA evaluates traditional post -approval extension studies and 510k post - approval extension studies via the Pre -Investigational Device Exemption (IDE) process. As a result of the Pre- IDE process, each study is assigned and identified by a single, 6 -digit pre-IDE number, preceded by the letter I (i.e. I123456). B. Policy Effective October 22, 2010, CMS has determined that all 510k post -approval extension studies must be reviewed by the FDA. The FDA will issue an acknowledgement letter stating that the extension study is scientifically valid and will generate clinically relevant post -market data. Upon receipt of this letter and review of the 510k post -approval extension study protocol, CMS will issue a letter to the study sponsor indicating that the study under review will be covered by Medicare. Since the FDA evaluates thes e studies via the Pre- IDE process, each 510k post -approval extension study will be identified by the I number assigned to the study when submitted to the FDA for review (i.e., the FREEDOM study examining the 510k- cleared Gore Flow Reversal System was ass igned I090962 and will be identified as such on all claims). C. Billing In order to receive Medicare coverage for patients participating in 510k post -approval extension studies, providers shall follow the same processes as explained above in section 160.2.1 (CAS for Post -Approval Studies). The only difference is that providers must report 510k- cleared devices with a pre- IDE number beginning with an I, instead of an IDE number beginning with a P (post -market approval). Contractors will issue a letter assigning an effective date for each facilitys participation in the extension study. Providers may bill for procedures performed in the extension study for dates of service on and after the assigned effective date utilizing the most current ICD -10 CM procedure codes. 161 - Intracranial Percutaneous Transluminal Angioplasty (PTA) With Stenting (Rev. 11021; Issued: 10- 01-21; Effective: 10 -29-21; Implementation: 10 -29-21) A. Background In the past, PTA to treat obstructive lesions of the cerebral arteries was non -covered by Medicare because the safety and efficacy of the procedure had not been established. This national coverage determination (NCD) meant that the procedure was also non -covered for beneficiaries participating in Food and Drug Administration (FDA) -approved investigational device exemption (IDE) clinical trials. B. Policy On February 9, 2006, a request for reconsideration of this NCD initiated a national coverage analysis. CMS reviewed the evidence and determined that intracranial PTA with stenting is reasonable and necessary under 1862(a)(1)(A) of the Social Security Act for the treatment of cerebral vessels (as specified in The National Coverage Determinations Manual, Chapter 1, part 1, section 20.7 ) only when furnished in accordance with FDA - approved protocols governing Category B IDE clinical trials. All other indications for intracranial PTA with stenting remain non -covered. Billing Providers of covered intracranial PTA with stenting shall use Category B IDE billing requirements, as listed above in section 68.4. In addition to these requirements, providers must bill the appropriate procedure and diagnosis codes for the date of service to receive payment. See the below ICD -10-CM diagnosis codes list applies, depending on the date of service. Indications for PTA and Stenting of Intracranial Arteries (must bill I67.2 and one of these primary codes to meet coverage under 20.7B5) If ICD -10-CM is applicable: I67.2 Cerebral atherosclerosis I66.01 Occlusion and stenosis of right middle cerebral artery I66.02 Occlusion and stenosis of left middle cerebral artery I66.03 Occlusion and stenosis of bilateral middle cerebral arteries I66.11 Occlusion and stenosis of right anterior cerebral artery I66.12 Occlusion and stenosis of left anterior cerebral artery I66.13 Occlusion and stenosis of bilateral anterior cerebral arteries I66.21 Occlusion and stenosis of right posterior cerebral artery I66.22 Occlusion and stenosis of left posterior cerebral artery I66.23 Occlusion and stenosis of bilateral posterior cerebral arteries I66.8 Occlusion and stenosis of other cerebral arteries I63.59 Cerebral infarction due to unspecified occlusion or stenosis of other cerebral artery If ICD -10-PCS is applicable, ICD-10- PCS procedure codes. That is, under Part A, providers must bill intracranial PTA using if ICD-10- PCS procedure codes is applicable.

(Medicare Claims Processing Manual)

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037G34Z Dilation of Intracranial Artery with Drug -eluting Intraluminal Device, Percutaneous Approach 037G35Z Dilation of Intracranial Artery with Two Drug -eluting Intraluminal Devices, Percutaneous Approach 037G36Z Dilation of Intracranial Artery with Three Drug -eluting Intraluminal Devices, Percutaneous Approach 037G37Z Dilation of Intracranial Artery with Four or More Drug -eluting Intraluminal Devices, Percutan Approach 037G3DZ Dilation of Intracranial Artery with Intraluminal Device, Percutaneous Approach 037G3EZ Dilation of Intracranial Artery with Two Intraluminal Devices, Percutaneous Approach 037G3FZ Dilation of Intracranial Artery with Three Intraluminal Devices, Percutaneous Approach 037G3GZ Dilation of Intracranial Artery with Four or More Intraluminal Devices, Percutaneous Approa 037G44Z Dilation of Intracranial Artery with Drug -eluting Intraluminal Device, Percutaneous Endoscop Approach 037G45Z Dilation of Intracranial Artery with Two Drug -eluting Intraluminal Devices, Percutaneous Endoscopic Approach 037G46Z Dilation of Intracranial Artery with Three Drug -eluting Intraluminal Devices, Percutaneous Endoscopic Approach 037G47Z Dilation of Intracranial Artery with Four or More Drug -eluting Intraluminal Devices, Percutan Endoscopic Approach 037G4DZ Dilation of Intracranial Artery with Intraluminal Device, Percutaneous Endoscopic Approach 037G4EZ Dilation of Intracranial Artery with Two Intraluminal Devices, Percutaneous Endoscopic Approach 037G4FZ Dilation of Intracranial Artery with Three Intraluminal Devices, Percutaneous Endoscopic Approach 037G4GZ Dilation of Intracranial Artery with Four or More Intraluminal Devices, Percutaneous Endosc Approach 037H34Z Dilation of Right Common Carotid Artery with Drug -eluting Intraluminal Device, Percutaneo Approach 037H35Z Dilation of Right Common Carotid Artery with Two Drug -eluting Intraluminal Devices, Percutaneous Approach 037H36Z Dilation of Right Common Carotid Artery with Three Drug -eluting Intraluminal Devices, Percutaneous Approach 037H37Z Dilation of Right Common Carotid Artery with Four or More Drug -eluting Intraluminal Devi Percutaneous Approach 037H3DZ Dilation of Right Common Carotid Artery with Intraluminal Device, Percutaneous Approach 037H3EZ Dilation of Right Common Carotid Artery with Two Intraluminal Devices, Percutaneous Approach 037H3FZ Dilation of Right Common Carotid Artery with Three Intraluminal Devices, Percutaneous Approach 037H3GZ Dilation of Right Common Carotid Artery with Four or More Intraluminal Devices, Percutane Approach 037H44Z Dilation of Right Common Carotid Artery with Drug -eluting Intraluminal Device, Percutaneo Endoscopic Approach 037H45Z Dilation of Right Common Carotid Artery with Two Drug -eluting Intraluminal Devices, Percutaneous Endoscopic Approach 037H46Z Dilation of Right Common Carotid Artery with Three Drug -eluting Intraluminal Devices, Percutaneous Endoscopic Approach 037H47Z Dilation of Right Common Carotid Artery with Four or More Drug -eluting Intraluminal Devi Percutaneous Endoscopic Approach 037H4DZ Dilation of Right Common Carotid Artery with Intraluminal Device, Percutaneous Endoscopi Approach 037H4EZ Dilation of Right Common Carotid Artery with Two Intraluminal Devices, Percutaneous Endoscopic Approach 037H4FZ Dilation of Right Common Carotid Artery with Three Intraluminal Devices, Percutaneous Endoscopic Approach 037H4GZ Dilation of Right Common Carotid Artery with Four or More Intraluminal Devices, Percutane Endoscopic Approach 037J34Z Dilation of Left Common Carotid Artery with Drug -eluting Intraluminal Device, Percutaneou Approach 037J35Z Dilation of Left Common Carotid Artery with Two Drug -eluting Intraluminal Devices, Percutaneous Approach 037J36Z Dilation of Left Common Carotid Artery with Three Drug -eluting Intraluminal Devices, Percutaneous Approach 037J37Z Dilation of Left Common Carotid Artery with Four or More Drug -eluting Intraluminal Device Percutaneous Approach 037J3DZ Dilation of Left Common Carotid Artery with Intraluminal Device, Percutaneous Approach 037J3EZ Dilation of Left Common Carotid Artery with Two Intraluminal Devices, Percutaneous Appro 037J3FZ Dilation of Left Common Carotid Artery with Three Intraluminal Devices, Percutaneous App 037J3GZ Dilation of Left Common Carotid Artery with Four or More Intraluminal Devices, Percutaneo Approach 037J44Z Dilation of Left Common Carotid Artery with Drug -eluting Intraluminal Device, Percutaneou Endoscopic Approach 037J45Z Dilation of Left Common Carotid Artery with Two Drug -eluting Intraluminal Devices, Percutaneous Endoscopic Approach 037J46Z Dilation of Left Common Carotid Artery with Three Drug -eluting Intraluminal Devices, Percutaneous Endoscopic Approach 037J47Z Dilation of Left Common Carotid Artery with Four or More Drug -eluting Intraluminal Device Percutaneous Endoscopic Approach 037J4DZ Dilation of Left Common Carotid Artery with Intraluminal Device, Percutaneous Endoscopic Approach 037J4EZ Dilation of Left Common Carotid Artery with Two Intraluminal Devices, Percutaneous Endoscopic Approach 037J4FZ Dilation of Left Common Carotid Artery with Three Intraluminal Devices, Percutaneous Endoscopic Approach 037J4GZ Dilation of Left Common Carotid Artery with Four or More Intraluminal Devices, Percutaneo Endoscopic Approach 037K34Z Dilation of Right Internal Carotid Artery with Drug -eluting Intraluminal Device, Percutaneou Approach 037K35Z Dilation of Right Internal Carotid Artery with Two Drug -eluting Intraluminal Devices, Percutaneous Approach 037K36Z Dilation of Right Internal Carotid Artery with Three Drug -eluting Intraluminal Devices, Percutaneous Approach 037K37Z Dilation of Right Internal Carotid Artery with Four or More Drug -eluting Intraluminal Device Percutaneous Approach 037K3DZ Dilation of Right Internal Carotid Artery with Intraluminal Device, Percutaneous Approach 037K3EZ Dilation of Right Internal Carotid Artery with Two Intraluminal Devices, Percutaneous Appro 037K3FZ Dilation of Right Internal Carotid Artery with Three Intraluminal Devices, Percutaneous Appr 037K3GZ Dilation of Right Internal Carotid Artery with Four or More Intraluminal Devices, Percutaneo Approach 037K44Z Dilation of Right Internal Carotid Artery with Drug -eluting Intraluminal Device, Percutaneou Endoscopic Approach 037K45Z Dilation of Right Internal Carotid Artery with Two Drug -eluting Intraluminal Devices, Percutaneous Endoscopic Approach 037K46Z Dilation of Right Internal Carotid Artery with Three Drug -eluting Intraluminal Devices, Percutaneous Endoscopic Approach 037K47Z Dilation of Right Internal Carotid Artery with Four or More Drug -eluting Intraluminal Device Percutaneous Endoscopic Approach 037K4DZ Dilation of Right Internal Carotid Artery with Intraluminal Device, Percutaneous Endoscopic Approach 037K4EZ Dilation of Right Internal Carotid Artery with Two Intraluminal Devices, Percutaneous Endoscopic Approach 037K4FZ Dilation of Right Internal Carotid Artery with Three Intraluminal Devices, Percutaneous Endoscopic Approach 037K4GZ Dilation of Right Internal Carotid Artery with Four or More Intraluminal Devices, Percutaneo Endoscopic Approach 037L34Z Dilation of Left Internal Carotid Artery with Drug -eluting Intraluminal Device, Percutaneous Approach 037L35Z Dilation of Left Internal Carotid Artery with Two Drug -eluting Intraluminal Devices, Percutaneous Approach 037L36Z Dilation of Left Internal Carotid Artery with Three Drug -eluting Intraluminal Devices, Percutaneous Approach 037L37Z Dilation of Left Internal Carotid Artery with Four or More Drug -eluting Intraluminal Devices Percutaneous Approach 037L3DZ Dilation of Left Internal Carotid Artery with Intraluminal Device, Percutaneous Approach 037L3EZ Dilation of Left Internal Carotid Artery with Two Intraluminal Devices, Percutaneous Approa 037L3FZ Dilation of Left Internal Carotid Artery with Three Intraluminal Devices, Percutaneous Appro 037L3GZ Dilation of Left Internal Carotid Artery with Four or More Intraluminal Devices, Percutaneou Approach 037L44Z Dilation of Left Internal Carotid Artery with Drug -eluting Intraluminal Device, Percutaneous Endoscopic Approach 037L45Z Dilation of Left Internal Carotid Artery with Two Drug -eluting Intraluminal Devices, Percutaneous Endoscopic Approach 037L46Z Dilation of Left Internal Carotid Artery with Three Drug -eluting Intraluminal Devices, Percutaneous Endoscopic Approach 037L47Z Dilation of Left Internal Carotid Artery with Four or More Drug -eluting Intraluminal Devices Percutaneous Endoscopic Approach 037L4DZ Dilation of Left Internal Carotid Artery with Intraluminal Device, Percutaneous Endoscopic Approach 037L4EZ Dilation of Left Internal Carotid Artery with Two Intraluminal Devices, Percutaneous Endosc Approach 037L4FZ Dilation of Left Internal Carotid Artery with Three Intraluminal Devices, Percutaneous Endoscopic Approach 037L4GZ Dilation of Left Internal Carotid Artery with Four or More Intraluminal Devices, Percutaneou Endoscopic Approach 037M34Z Dilation of Right External Carotid Artery with Drug -eluting Intraluminal Device, Percutaneou Approach 037M35Z Dilation of Right External Carotid Artery with Two Drug -eluting Intraluminal Devices, Percutaneous Approach 037M36Z Dilation of Right External Carotid Artery with Three Drug -eluting Intraluminal Devices, Percutaneous Approach 037M37Z Dilation of Right External Carotid Artery with Four or More Drug -eluting Intraluminal Devic Percutaneous Approach 037M3DZ Dilation of Right External Carotid Artery with Intraluminal Device, Percutaneous Approach 037M3EZ Dilation of Right External Carotid Artery with Two Intraluminal Devices, Percutaneous Appr 037M3FZ Dilation of Right External Carotid Artery with Three Intraluminal Devices, Percutaneous Approach 037M3GZ Dilation of Right External Carotid Artery with Four or More

(Medicare Claims Processing Manual)

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Endoscopic Approach 037L4GZ Dilation of Left Internal Carotid Artery with Four or More Intraluminal Devices, Percutaneou Endoscopic Approach 037M34Z Dilation of Right External Carotid Artery with Drug -eluting Intraluminal Device, Percutaneou Approach 037M35Z Dilation of Right External Carotid Artery with Two Drug -eluting Intraluminal Devices, Percutaneous Approach 037M36Z Dilation of Right External Carotid Artery with Three Drug -eluting Intraluminal Devices, Percutaneous Approach 037M37Z Dilation of Right External Carotid Artery with Four or More Drug -eluting Intraluminal Devic Percutaneous Approach 037M3DZ Dilation of Right External Carotid Artery with Intraluminal Device, Percutaneous Approach 037M3EZ Dilation of Right External Carotid Artery with Two Intraluminal Devices, Percutaneous Appr 037M3FZ Dilation of Right External Carotid Artery with Three Intraluminal Devices, Percutaneous Approach 037M3GZ Dilation of Right External Carotid Artery with Four or More Intraluminal Devices, Percutaneo Approach 037M44Z Dilation of Right External Carotid Artery with Drug -eluting Intraluminal Device, Percutaneou Endoscopic Approach 037M45Z Dilation of Right External Carotid Artery with Two Drug -eluting Intraluminal Devices, Percutaneous Endoscopic Approach 037M46Z Dilation of Right External Carotid Artery with Three Drug -eluting Intraluminal Devices, Percutaneous Endoscopic Approach 037M47Z Dilation of Right External Carotid Artery with Four or More Drug -eluting Intraluminal Devic Percutaneous Endoscopic Approach 037M4DZ Dilation of Right External Carotid Artery with Intraluminal Device, Percutaneous Endoscopic Approach 037M4EZ Dilation of Right External Carotid Artery with Two Intraluminal Devices, Percutaneous Endoscopic Approach 037M4FZ Dilation of Right External Carotid Artery with Three Intraluminal Devices, Percutaneous Endoscopic Approach 037M4GZ Dilation of Right External Carotid Artery with Four or More Intraluminal Devices, Percutaneo Endoscopic Approach 037N34Z Dilation of Left External Carotid Artery with Drug -eluting Intraluminal Device, Percutaneous Approach 037N35Z Dilation of Left External Carotid Artery with Two Drug -eluting Intraluminal Devices, Percutaneous Approach 037N36Z Dilation of Left External Carotid Artery with Three Drug -eluting Intraluminal Devices, Percutaneous Approach 037N37Z Dilation of Left External Carotid Artery with Four or More Drug -eluting Intraluminal Device Percutaneous Approach 037N3DZ Dilation of Left External Carotid Artery with Intraluminal Device, Percutaneous Approach 037N3EZ Dilation of Left External Carotid Artery with Two Intraluminal Devices, Percutaneous Appro 037N3FZ Dilation of Left External Carotid Artery with Three Intraluminal Devices, Percutaneous Appr 037N3GZ Dilation of Left External Carotid Artery with Four or More Intraluminal Devices, Percutaneou Approach 037N44Z Dilation of Left External Carotid Artery with Drug -eluting Intraluminal Device, Percutaneous Endoscopic Approach 037N45Z Dilation of Left External Carotid Artery with Two Drug -eluting Intraluminal Devices, Percutaneous Endoscopic Approach 037N46Z Dilation of Left External Carotid Artery with Three Drug -eluting Intraluminal Devices, Percutaneous Endoscopic Approach 037N47Z Dilation of Left External Carotid Artery with Four or More Drug -eluting Intraluminal Device Percutaneous Endoscopic Approach 037N4DZ Dilation of Left External Carotid Artery with Intraluminal Device, Percutaneous Endoscopic Approach 037N4EZ Dilation of Left External Carotid Artery with Two Intraluminal Devices, Percutaneous Endos Approach 037N4FZ Dilation of Left External Carotid Artery with Three Intraluminal Devices, Percutaneous Endoscopic Approach 037N4GZ Dilation of Left External Carotid Artery with Four or More Intraluminal Devices, Percutaneou Endoscopic Approach

(Medicare Claims Processing Manual)

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clm104c32.pdf

f391a081-5e5c-4a59-a546-6ffe0086f907

Under Part B, providers must bill HCPCS procedure code 37799. If above ICD -10-CM is applicable. NOTE: ICD- codes are subject to modification. Providers must always ensure they are using the latest and most appropriate codes. 170 - Billing Requirements for Lumbar Artificial Disc Replacement (Rev. 992, Issued: 06- 23-06, Effective: 05 -16-06, Implementation: Carriers 07- 17-06/FIs 10- 01-06) 170.1 - General (Rev. 1340, Issued: 09- 21-07, Effective: 08 -14-07, Implementation: 10- 01-07) Effective for services performed from May 16, 2006 through August 13, 2007, the Centers for Medicare & Medicaid Services (CMS) made the decision that lumbar artificial disc replacement (LADR) with the ChariteTM lumbar artificial disc is non -covered for Medicare beneficiaries over 60 years of age. See Pub. 100-03, Medicare National Coverage Determinations Manual, section 150.10, for more information about the non-covered determination. Effective for services performed on or after August 14, 2007, CMS made the decision that LADR with any lumbar artificial disc is non -covered for Medicare beneficiaries over 60 years of age, (i.e., on or after a beneficiarys 61st birthday). For Medicare beneficiaries 60 years of age and younger, there is no national coverage determination for LADR, leaving such determinations to continue to be made by the local contractors. 170.2 - Carrier Billing Requirements (Rev. 11902; Issued:03- 16-23; Effective: 04 -17-23; Implementation: 04 -17-23) Effective for services performed on or after May 16, 2006 through December 31, 2006, carriers shall deny claims, for Medicare beneficiaries over 60 years of age, submitted with the following Category III Codes: 0091T Single interspace, lumbar; and 0092T Each additional interspace (List separately in addition to code for primary procedure.) Effective for services performed on or after January 1, 2007 through August 13, 2007, for Medicare beneficiaries over 60 years of age, LADR with the ChariteTM lumbar artificial disc, carriers shall deny claims submitted with the following codes: 22857 Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression), lumbar, single interspace 0163T Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression), lumbar, each additional interspace. NOTE: Effective December 31, 2022, code 0163T is end dated. Carriers shall continue to follow their normal claims processing criteria for IDEs for LADR performed with an implant eligible under the IDE criteria. For dates of service May 16, 2006 through August 13, 2007, Medicare coverage under the investigational device exemption (IDE) for LADR with a disc other than the ChariteTM lumbar disc in eligible clinical trials is not impacted. Effective for services performed on or after August 14, 2007, carriers shall deny claims for LADR surgery, for Medicare beneficiaries over 60 years of age, (i.e., on or after a beneficiarys 61st birthday) submitted with the following codes: 22857 Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression), lumbar, single interspace 0163T Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression), lumbar, each additional interspace NOTE: Effective December 31, 2022, code 0163T is end dated. 22860 Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression); second interspace, lumbar. Effective 01/01/23 170.3 - A/B MAC (A) Billing Requirements (Rev. 2998, Issued: 07- 25-14, Effective: Upon implementation of ICD -10; 01- 01-12 - ASC X12, Implementation: 08 -25-2014 - ASC X12; Upon Implementation of ICD -10) The A/B MAC (A) will pay for LADR when approved under the IDE/clinical trial criteria only when submitted with ICD -9-CM procedure code 84.65 if ICD -9 is applicable, with condition code 30 and if ICD -9-CM is applicable , ICD-9-CM diagnosis code V70.7 when submitted on type of bill (TOB) 11X from May 16, 2006 through August 13, 2007. Special Billing instructions: For services performed on TOB 11X in critical access hospitals (CAH), the payment will be 101% of reasonable cost. For services performed on TOB 11X Indian Health Services (IHS) inpatient hospitals will pay under the inpatient prospective payment system (IPPS) based on the DRG. For services performed on TOB 11X, IHS CAHs will pay under 101% facility specific per diem rate. NOTE: The ICD -9-CM procedure code 84.65 is not payable for beneficiaries over 60 years of age, with the ChariteTM lumbar artificial disc, which is the only one that is FDA approved for any diagnosis. If a different manufactures disc is used in an approved clinical trials or is an approved IDE, then condition code 30 and ICD-9-CM diagnosis code V70.7 must be on the claim for it to be payable. Effective for discharges on or after August 14, 2007, CMS has found that LADR is not reasonable and necessary for the Medicare population over 60 years of age. Therefore, LADR is non- covered for Medicare beneficiaries over 60 years of age as identified in section 150.10, of Pub.100- 03, the NCD Manual. A/B MACS (A) shall deny claims with ICD -9-CM procedure code 84.65 for Medicare beneficiaries over 60 years of age. For Medicare beneficiaries 60 years of age and younger, there is no NCD, leaving such determinations to continue to be made by the local contractors. 170.4 Reasons for Denial and Medicare Summary Notice (MSN), Claim Adjustment Reason Code Messages, and Remittance Advice Remark Code (Rev. 1340, Issued: 09- 21-07, Effective: 08 -14-07, Implementation: 10- 01-07) Contractors shall use the following messages when denying claims for Medicare beneficiaries over 60 years of age (i.e. on or after a beneficiarys 61st birthday). 21.24 This service is not covered for patients over age 60. Este servicio no est cubierto en pacientes mayores de 60 aos. Use an appropriate Claim Adjustment Reason Code: 96 "Non -covered charge(s)." Use an appropriate Remittance Advice Remark Code: 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 http://www.cms.hhs.gov/mcd/search.asp. If you do not have Web access, you may contact the contractor to request a copy of the NCD. 170.5 - Advance Beneficiary Notice (ABN) and Hospital Issued Notice of Noncoverage (HINN) Information (Rev. 1340, Issued: 09- 21-07, Effective: 08 -14-07, Implementation: 10- 01-07) Providers must be advised that the provider is liable for charges if the lumbar artificial disc replacement is used in the surgery, unless the beneficiary was informed that he/she would be financially responsible prior to performance of the procedure. To avoid this liability the provider should have the beneficiary sign an ABN. The HINN model language should be adapted to this situation in the sections addressing description of the care at issue if the surgery is performed on an inpatient basis. Unless the beneficiary was informed prior to the admission that he/ she would be fina ncially liable for the admission, the provider is liable. To avoid this liability the provider must issue a HINN. Other content requirements of a HINN still apply. Use the HINN letter most appropriate to the overall situation. 180 Cryosurgery of the Prostate Gland (Rev. 1111, Issued: 11- 09-06, Effective: 04 -01-07, Implementation: 04- 02-07) Cryosurgery of the prostate gland, also known as cryosurgical ablation of the prostate (CAP), destroys prostate tissue by applying extremely cold temperatures in order to reduce the size of the prostate gland. 180.1 - Coverage Requirements (Rev. 1111, Issued: 11- 09-06, Effective: 04 -01-07, Implementation: 04- 02-07) Medicare covers cryosurgery of the prostate gland effective for claims with dates of service on or after July 1, 1999. The coverage is for: 1. Primary treatment of patients with clinically localized prostate cancer, Stages T1 T3 (diagnosis code is 185 malignant neoplasm of prostate). 2. Salvage therapy (effective for claims with dates of service on or after July 1, 2001 for patients: a. Having recurrent, localized prostate cancer; b. Failing a trial of radiation therapy as their primary treatment; and c. Meeting one of these conditions: State T2B or below; Gleason score less than 9 or; PSA less than 8 ng/ml. 180.2 - Billing Requirements (Rev. 2998, Issued: 07- 25-14, Effective: Upon implementation of ICD-10; 01-01-12 - ASC X12, Implementation: 08 -25-2014 - ASC X12; Upon Implementation of ICD-10) Claims for cryosurgery for the prostate gland are to be submitted on the ASC X12 837, or, in exceptional circumstances, on a hard copy Form CMS 1450. This procedure can be rendered in an inpatient or outpatient hospital setting (types of bill (TOBs) 11x 13x, 83x, and 85x). The A/B MAC (A) will look for the following when processing claims with cryosurgery services: If ICD -9-CM is applicable, ICD-9 CM diagnosis code 185 or If ICD -10-CM is applicable, ICD-10 CM diagnosis code C61 must be on all cryosurgical claims; For outpatient claims HCPCS 55873 and revenue codes 0360, 0361, or 0369 Cryosurgery ablation of localized prostate cancer, stages T1 - T3 (includes ultrasonic guidance for interstitial cryosurgery probe placement, postoperative irrigations and aspiration of sloughing tissue included) must be on all outpatient claims; and For inpatient claims correct procedure codes are: o If ICD -9-CM is applicable, ICD-9-CM procedure code 60.62 (perineal prostatectomy- the definition includes cryoablation of prostate, cryostatectomy of prostate, and radical cryosurgical ablation of prostate) o If ICD -10 is applicable,ICD-10-PCS procedure code 0V500ZZ (Destruction of Prostate, Open Approach), or 0V503ZZ (Destruction of Prostate, Percutaneous Approach), or 0V504ZZ (Destruction of Prostate, Percutaneous Endoscopic Approach). 180.3 Payment Requirements (Rev. 1111, Issued: 11- 09-06, Effective: 04-01-07, Implementation: 04-02-07) This service may be paid as a primary treatment for patients with clinically localized prostate cancer, Stages T1 T3. The ultrasonic guidance associated with this procedure will not be paid for separately, but is bundled into the payment for the surgical procedure. When one provider has furnished the cryosurgical ablation and another the ultrasonic guidance, the provider of the ultrasonic guidance must seek compensation from the provider of the cryosurgical ablation.

(Medicare Claims Processing Manual)

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clm104c32.pdf

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For inpatient claims correct procedure codes are: o If ICD -9-CM is applicable, ICD-9-CM procedure code 60.62 (perineal prostatectomy- the definition includes cryoablation of prostate, cryostatectomy of prostate, and radical cryosurgical ablation of prostate) o If ICD -10 is applicable,ICD-10-PCS procedure code 0V500ZZ (Destruction of Prostate, Open Approach), or 0V503ZZ (Destruction of Prostate, Percutaneous Approach), or 0V504ZZ (Destruction of Prostate, Percutaneous Endoscopic Approach). 180.3 Payment Requirements (Rev. 1111, Issued: 11- 09-06, Effective: 04-01-07, Implementation: 04-02-07) This service may be paid as a primary treatment for patients with clinically localized prostate cancer, Stages T1 T3. The ultrasonic guidance associated with this procedure will not be paid for separately, but is bundled into the payment for the surgical procedure. When one provider has furnished the cryosurgical ablation and another the ultrasonic guidance, the provider of the ultrasonic guidance must seek compensation from the provider of the cryosurgical ablation. Effective July 1, 2001, cryosurgery performed as salvage therapy, will be paid only according to the coverage requirements described above. Type of facility and setting determines the basis of payment: For services performed on an inpatient or outpatient basis in a CAH, TOBs 11x and 85x: the FI will pay 101 percent of reasonable cost minus any applicable deductible and coinsurance. For services performed on an inpatient basis in short term acute care hospitals, (including those in Guam, America Samoa, Virgin Islands, Saipan, and Indian Health Services Hospitals) TOB 11x: the FI will pay the DRG payment minus any applicable deductibl e and coinsurance. For services performed on an outpatient basis in hospitals subject to the Outpatient PPS, TOB 13x: the FI will pay the assigned APC minus any applicable deductible and coinsurance. For outpatient services in hospitals that are exempt from OPPS (such as in American Samoa, Virgin Islands, Guam, and Saipan) TOBs 13x: the FI will pay reasonable cost, minus any applicable deductible and coinsurance. For outpatient services in Indian Health Service hospitals TOBs 13x and 83x: the FI will pay the ASC payment amount for TOB 83x. minus any applicable deductible and coinsurance. For inpatient or outpatient services in hospitals in Maryland, make payment according to the State Cost Containment system. For services performed on an inpatient basis: the hospitals exempt from inpatient acute care PPS shall be paid on reasonable cost basis, minus any applicable deductible and coinsurance. 180.4 - Claim Adjustment Reason Codes, Remittance Advice Remark Codes, Group Codes, and Medicare Summary Notice Messages (Rev 2544, Issued: 09 -13-2012, Effective: 10 -01-2012, Implementation: 10- 01-2012) 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 alcohol misuse screening and alcohol misuse behavioral counseling sessions: For RHC and FQHC claims that contain screening for alcohol misuse HCPCS code G0442 and alcohol misuse counseling HCPCS code G0443 with another encounter/visit with the same line item date of service, use group code CO and reason code: o Claim Adjustment Reason Code (CARC) 97 The benefit for this service is included in the payment/allowance for another service/procedure that has already been adjudicated. Note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Servic e Payment Information REF) if present Denying claims containing HCPCS code G0442 and HCPCS code G0443 submitted on a TOB other than 13X, 71X, 77X, and 85X: o Claim Adjustment Reason Code (CARC) 5 - The procedure code/bill type is inconsistent with the place of service. Note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF) if present o Remittance Advice Remark Code (RARC) M77 Missing/incomplete/invalid place of service o Group Code PR (Patient Responsibility) assigning financial liability to the beneficiary, if a claim is received with a GA modifier indicating a signed ABN is on file. o Group Code CO (Contractual Obligation) assigning financial liability to the provider, if a claim is received with a GZ modifier indicating no signed ABN is on file. NOTE: For modifier GZ, use CARC 50 and MSN 8.81 per instructions in CR 7228/TR 2148. Denying claims that contains more than one alcohol misuse behavioral counseling session G0443 on the same date of service: o Medicare Summary Notice (MSN) 15.6 The information provided does not support the need for this many services or items within this period of time. o Claim Adjustment Reason Code (CARC) 151 Payment adjusted because the payer deems the information submitted does not support this many/frequency of services. o Remittance Advice Remark Code (RARC) M86 Service denied because payment already made for same/similar procedure within set time frame. o Group Code PR (Patient Responsibility) assigning financial liability to the beneficiary, if a claim is received with a GA modifier indicating a signed ABN is on file. o Group Code CO (Contractual Obligation) assigning financial liability to the provider, if a claim is received with a GZ modifier indicating no signed ABN is on file. NOTE: For modifier GZ, use CARC 50 and MSN 8.81 per instructions in CR 7228/TR 2148. Denying claims that are not submitted from the appropriate provider specialties: o Medicare Summary Notice (MSN) 21.18 This item or service is not covered when performed or ordered by this provider. o Claim Adjustment Reason Code (CARC) 185 - The rendering provider is not eligible to perform the service billed. NOTE: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. o Remittance Advice Remark Code (RARC) N95 - This provider type/provider specialty may not bill this service. o Group Code PR (Patient Responsibility) assigning financial liability to the beneficiary, if a claim is received with a GA modifier indicating a signed ABN is on file. o Group Code CO (Contractual Obligation) assigning financial liability to the provider, if a claim is received with a GZ modifier indicating no signed ABN is on file. NOTE: For modifier GZ, use CARC 50 and MSN 8.81 per instructions in CR 7228/TR 2148. Denying claims without the appropriate POS code: o Medicare Summary Notice (MSN) 21.25 This service was denied because Medicare only covers this service in certain settings. o Claim Adjustment Reason Code (CARC) 58 Treatment was deemed by the payer to have been rendered in an inappropriate or invalid place of service. Note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF) if present. o Remittance Advice Remark Code (RARC) N428 Not covered when performed in this place of service. o Group Code PR (Patient Responsibility) assigning financial liability to the beneficiary, if a claim is received with a GA modifier indicating a signed ABN is on file. o Group Code CO (Contractual Obligation) assigning financial liability to the provider, if a claim is received with a GZ modifier indicating no signed ABN is on file. NOTE: For modifier GZ, use CARC 50 and MSN 8.81 per instructions in CR 7228/TR 2148. Denying claims for alcohol misuse screening HCPCS code G0442 more than once in a 12- month period, and denying alcohol misuse counseling sessions HCPCS code G0443 more than four times in the same 12 -month period: o Medicare Summary Notice (MSN) 20.5 These services cannot be paid because your benefits are exhausted at this time. o Claim Adjustment Reason Code (CARC) 119 Benefit maximum for this time period or occurrence has been reached. o Remittance Advice Remark Code (RARC) N362 The number of Days or Units of service exceeds our acceptable maximum. o Group Code PR (Patient Responsibility) assigning financial liability to the beneficiary, if a claim is received with a GA modifier indicating a signed ABN is on file. o Group Code CO (Contractual Obligation) assigning financial liability to the provider, if a claim is received with a GZ modifier indicating no signed ABN is on file. NOTE: For modifier GZ, use CARC 50 and MSN 8.81 per instructions in CR 7228/TR 2148. Denying claims for alcohol misuse counseling session HCPCS code G0443 when there is no claim in history for the screening service HCPCS code G0442 in the prior 12 months: Medicare Summary Notice (MSN) 16.26 Medicare does not pay for services or items related to a procedure that has not been approved or billed. Claim Adjustment Reason Code (CARC) B15 This service/procedure requires that a qualifying service/procedure be received and covered. The qualifying other service/procedure has not been received/adjudicated. Note: Refer to the 835 Healthcare Policy Iden tification Segment (loop 2110 Service Payment Information REF), if present. Remittance Advice Remark Code (RARC) M16 Alert: Please see our web site, mailings, or bulletins for more details concerning this policy/procedure/decision. Group Code PR (Patient Responsibility) assigning financial liability to the beneficiary, if a claim is received with a modifier indicating a signed ABN is on file. Group Code CO (Contractual Obligation) assigning financial liability to the provider, if a claim is received without a modifier indicating no signed ABN is on file. 180.5 Additional CWF and Contractor Requirements (Rev 2544, Issued: 09- 13-2012, Effective: 10 -01-2012, Implementation: 10- 01-2012) When applying frequency, CWF shall count 11 full months following the month of the last alcohol misuse screening visit, G0442, before allowing subsequent payment of another G0442 screening. CWF shall reject incoming claims when G0443 PROF is billed if four G0443 services have been billed and posted to the BEHV auxiliary file within the 12 month period. CWF shall continue to reject incoming claims with consistency error code 32#3 when HCPCS code G0442 PROF and HCPCS code G0443 PROF are billed on same day for TOB 71X, 77X, 85X with 096X, 097X and 098X. Contractors and CWF shall use the last date of G0442 PROF for counting the 12- month period for G0443 PROF services. Contractors and CWF shall apply all the same TOBs (13x,71x, 77x and 85x with Rev. Code 96, 97 and 98) POS (11, 22, 49 and 71), no deductible/co- insurance and institutional/professional processing for G0443 that was implemented for G0442 in CR 7633. If a claim with G0442 is cancelled, CWF shall do a look back for claims with G0443 and create an IUR (Information Unsolicited Response) along with a Trailer 24 back to the contractor to reject the G0443 claim(s) paid within the 12 month period of the G0442 claims. CWF shall display the number of counseling sessions remaining for G0443 PROF on all CWF provider query screens (HUQA, HIQA, HIQH, ELGA, ELGB, ELGH). CWF shall display the remaining PROF services counting DOWN from four (4) for the HCPCS code G0443 on the MBD/NGD extract file. CWF shall calculate a next eligible date for G0442 PROF and G0443 PROF for a given beneficiary. The calculation shall include all applicable factors including beneficiary Part B entitlement status, beneficiary claims history and utilization rules. When there is no next eligible date, the CWF provider query screens shall display an 8- position alpha code in the date field to indicate why there is not a next eligible date. Any change to beneficiary master data or claims data that would result in a change to any next eligible date shall result in an update to the beneficiarys next eligible date. NOTE: If G0442 is not paid, the beneficiary is not eligible for G0443. CWF shall create a utility to remove previously posted G0442 TECH for the AUX file.

(Medicare Claims Processing Manual)

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clm104c32.pdf

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CWF shall display the number of counseling sessions remaining for G0443 PROF on all CWF provider query screens (HUQA, HIQA, HIQH, ELGA, ELGB, ELGH). CWF shall display the remaining PROF services counting DOWN from four (4) for the HCPCS code G0443 on the MBD/NGD extract file. CWF shall calculate a next eligible date for G0442 PROF and G0443 PROF for a given beneficiary. The calculation shall include all applicable factors including beneficiary Part B entitlement status, beneficiary claims history and utilization rules. When there is no next eligible date, the CWF provider query screens shall display an 8- position alpha code in the date field to indicate why there is not a next eligible date. Any change to beneficiary master data or claims data that would result in a change to any next eligible date shall result in an update to the beneficiarys next eligible date. NOTE: If G0442 is not paid, the beneficiary is not eligible for G0443. CWF shall create a utility to remove previously posted G0442 TECH for the AUX file. CWF shall remove G0442/G0443 TECH from editing, MBD, NGD, Provider Inquiry screens and all other applicable areas (i.e., HICR) previously done under CR 7633. Frequency Requirements When applying frequency, CWF shall count 11 full months following the month of the last alcohol misuse screening visit, G0442, before allowing subsequent payment of another G0442 screening. Additionally, CWF shall create an edit to allow alcohol misuse br ief behavioral counseling, HCPCS G0443, no more than 4 times in a 12- month period. CWF shall also count four alcohol misuse counseling sessions HCPCS G0443 in the same 12 -month period used for G0442 counting from the date the G0442 screening session was bi lled. When applying frequency limitations to G0442 screening on the same date of service as G0443 counseling, CWF shall allow both a claim for the professional service and a claim for a facility fee. CWF shall identify the following institutional claims as facility fee claims for screening services: TOB 13X, TOB 85X when the revenue code is not 096X, 097X, or 098X. CWF shall identify all other claims as professional service claims for screening services (professional claims, and institutional claims with TOB 71 X, 77X, and 85X when the revenue code is 096X, 097X, or 098X). NOTE: This does not apply to RHCs and FQHCs. 190 Billing Requirements for Extracorporeal Photopheresis (Rev. 3050, Issued: 08- 22-14, Effective: 09 -23-14, ICD -10: Upon Implementation of ICD -10, Implementation: 09 -23-14, ICD -10: Upon Implementation of ICD- 10) Effective for dates of services on and after December 19, 2006, Medicare has expanded coverage for extracorporeal photopheresis for patients with acute cardiac allograft rejection whose disease is refractory to standard immunosuppresive drug treatment and patients with chronic graft versus host disease whose disease is refractory to standard immunosuppresive drug treatment. (See the National Coverage Determinations (NCD) Manual, Pub. 100 -03, Chapter 1, part 2, section 110.4, for complete coverage guidelines .) Effective for claims with dates of service on or after April 30, 2012, the Centers for Medicare & Medicaid Services has expanded coverage for extracorporeal photopheresis for the treatment of bronchiolitis obliterans syndrome ( BOS) following lung allograft transplantation only when extracorporeal photopheresis is provided under a clinical research study that meets specific requirements to assess the effect of extracorporeal photopheresis for the treatment of BOS following lung a llograft transplantation. Fur ther coverage criteria is outlined in Pub. 100- 03, Chapter 1, part 2, section 110.4 of the NCD Manual. 190.1 Applicable Intermediary Bill Types (Rev. 1206; Issued: 03- 16-07; Effective: December 19, 2006; Implementation: 04- 02-07) 11X, 13X, or 85X 190.2 Healthcare Common Procedural Coding System (HCPCS), Applicable Diagnosis Codes and Procedure Code (Rev.10881; Issued: 08-06-2021; Effective: 09- 07-2021; Implementation: 09-07- 2021) The following HCPCS procedure code is used for billing extracorporeal photopheresis: 36522 - Photopheresis, extracorporeal Effective for claims with dates of service on or after Oct 1, 2015, the following are the applicable ICD-10-CM procedure codes for the new expanded coverage: 6A650ZZ Phototherapy, Circulatory, Single 6A651ZZ Phototherapy, Circulatory, Multiple NOTE: Contractors shall edit for an appropriate oncological and autoimmune disorder diagnosis for payment of extracorporeal photopheresis according to the NCD. Effective for claims with dates of service on or after Oct 1, 2015, in addition to HCPCS 36522, the following ICD-10-CM codes are applicable for extracorporeal photopheresis for the treatment of BOS following lung allograft transplantation only when extracorporeal photopheresis is provided under a clinical research study as outlined in above sections 190 and 190.2 Healthcare Common Procedural Coding System (HCPCS) codes, and applicable diagnosis codes as below:: A reference listing of ICD -10-CM coding and descriptions is listed below: CUTANEOUS T -CELL LYMPHOMA C84.01 Mycosis fungoides, lymph nodes of head, face, and neck C84.02 Mycosis fungoides, intrathoracic lymph nodes C84.03 Mycosis fungoides, intra -abdominal lymph nodes C84.04 Mycosis fungoides, lymph nodes of axilla and upper limb C84.05 Mycosis fungoides, lymph nodes of inguinal region and lower limb C84.06 Mycosis fungoides, intrapelvic lymph nodes C84.07 Mycosis fungoides, spleen C84.08 Mycosis fungoides, lymph nodes of multiple sites C84.09 Mycosis fungoides, extranodal and solid organ sites C84.11 Szary disease, lymph nodes of head, face, and neck C84.12 Szary disease, intrathoracic lymph nodes C84.13 Szary disease, intra -abdominal lymph nodes C84.14 Szary disease, lymph nodes of axilla and upper limb C84.15 Szary disease, lymph nodes of inguinal region and lower limb C84.16 Szary disease, intrapelvic lymph nodes C84.17 Szary disease, spleen C84.18 Szary disease, lymph nodes of multiple sites C84.19 Sezary disease, extranodal/solid organ sites C84.A0 Cutaneous T -cell lymphoma, unspecified, unspecified site C84.A1 Cutaneous T -cell lymphoma, unspecified lymph nodes of head, face, and neck C84.A2 Cutaneous T -cell lymphoma, unspecified, intrathoracic lymph nodes C84.A3 Cutaneous T -cell lymphoma, unspecified, intra -abdominal lymph nodes C84.A4 Cutaneous T -cell lymphoma, unspecified, lymph nodes of axilla and upper limb C84.A5 Cutaneous T -cell lymphoma, unspecified, lymph nodes of inguinal region and lower limb C84.A6 Cutaneous T -cell lymphoma, unspecified, intrapelvic lymph nodes C84.A7 Cutaneous T -cell lymphoma, unspecified, spleen C84.A8 Cutaneous T -cell lymphoma, unspecified, lymph nodes of multiple sites C84.A9 Cutaneous T -cell lymphoma, unspecified, extranodal and solid organ sites ACUTE CARDIAC ALLOGRAFT REJECTION/GRAFT -VERSUS -HOST -DISEASE D89.811 Chronic graft -versus -host disease D89.812 Acute on chronic graft -versus -host disease D89.813 Graft -versus -host disease, unspecified T86.01 Bone marrow transplant rejection T86.02 Bone marrow transplant failure T86.03 Bone marrow transplant infection T86.21 Heart transplant rejection T86.22 Heart transplant failure T86.23 Heart transplant infection T86.290 Cardiac allograft vasculopathy T86.31 Heart -lung transplant rejection T86.32 Heart -lung transplant failure T86.33 Heart -lung transplant infection T86.5 Complications of stem cell transplant Z94.3 Heart and lungs transplant status Z94.81 Bone marrow transplant status BOS (CED/TRIAL ONLY) J42 Unspecified chronic bronchitis J44.0 Chronic obstructive pulmonary disease with (acute) lower respiratory infection J44.1 Chronic obstructive pulmonary disease with (acute) exacerbation J44.9 Chronic obstructive pulmonary disease, unspecified T86.810 Lung transplant rejection T86.811 Lung transplant failure T86.812 Lung transplant infection T86.818 Other complications of lung transplant T86.819 Unspecified complication of lung transplant Z94.2 Lung transplant status Z00.6 Encounter for examination for normal comparison and control in clinical research program 190.3 Medicare Summary Notices (MSNs), Remittance Advice Remark Codes (RAs) and Claim Adjustment Reason Code (Rev.10881; Issued: 08-06-2021; Effective: 09- 07-2021; Implementation: 09-07- 2021) Contractors shall continue to use the appropriate existing messages that they have in place when denying claims submitted that do not meet the Medicare coverage criteria for extracorporeal photopheresis. Medicare coverage for extracorporeal photopheresis is restricted to the inpatient or outpatient hospital settings specifically for BOS, and not for the other covered diagnosis (including chronic graft versus host disease) which remain covered in the hospital inpatient, hospital outpatient, and non- facility (physician -directed clinic or office settings) settings. Contractors shall deny claims for extracorporeal photopheresis for BOS when the service is not rendered to an inpatient or outpatient of a hospital, including critical access hospitals using the following codes: Claim Adjustment Reason Code (CARC) 96 Non -covered charge(s). At least one Remark Code must be provided (may be comprised of either the NCPDP Reject Reason [sic] Code, or Remittance Advice Remark Code that is not an ALERT.) NOTE : Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. CARC 171 Payment is denied when performed/billed by this type of provider in this type of facility. NOTE : Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. Medicare Summary Notice 16.2 - This service cannot be paid when provided in this location/facility." Spanish translation: "Este servicio no se puede pagar cuando es suministrado en esta sitio/facilidad. (Include either MSN 36.1 or 36.2 dependent on liability.) Remittance Advice Remark Code (RARC) N428 Not covered when performed in this place of service. (A/MACs only) B. Group Code CO (Contractual Obligations) or PR (Patient Responsibility) dependent on liability. Contractors shall return to provider/ return as unprocessable claims for BOS containing HCPCS procedure code 36522 along with one of the allowable ICD -10 codes if the claim is missing diagnosis code Z00.6 (as primary/secondary diagnosis, institutional only), condition code 30 (institutional claims only), clinical trial modifier Q0/Q1, and value code D4 with an 8- digit clinical trial identifier number (A/MACs only). Use the following messages: When diagnosis code Z00.6 is missing, use: CARC 16 Claim/service lacks information or has submission/billing error(s). and RARC M76, Missing/incomplete/invalid diagnosis or condition. When Condition Code 30 is missing, use CARC 16 and RARC M44 Missing/incomplete/invalid condition code. When Clinical Trial modifier Q0/Q1 is missing, use CARC 16 and RARC N822, Missing procedure modifier(s).

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Remittance Advice Remark Code (RARC) N428 Not covered when performed in this place of service. (A/MACs only) B. Group Code CO (Contractual Obligations) or PR (Patient Responsibility) dependent on liability. Contractors shall return to provider/ return as unprocessable claims for BOS containing HCPCS procedure code 36522 along with one of the allowable ICD -10 codes if the claim is missing diagnosis code Z00.6 (as primary/secondary diagnosis, institutional only), condition code 30 (institutional claims only), clinical trial modifier Q0/Q1, and value code D4 with an 8- digit clinical trial identifier number (A/MACs only). Use the following messages: When diagnosis code Z00.6 is missing, use: CARC 16 Claim/service lacks information or has submission/billing error(s). and RARC M76, Missing/incomplete/invalid diagnosis or condition. When Condition Code 30 is missing, use CARC 16 and RARC M44 Missing/incomplete/invalid condition code. When Clinical Trial modifier Q0/Q1 is missing, use CARC 16 and RARC N822, Missing procedure modifier(s). When Clinical Trial Number is missing, use CARC 16 and RARC MA50, Missing/incomplete/invalid Investigational Device Exemption number or Clinical Trial number. When Value Code D4 is missing, use CARC 16 and RARC M49, Missing/incomplete/invalid value code(s) or amount(s). 190.4 Advance Beneficiary Notice and Hospital Issued Notice of Noncoverage Information (Rev. 1206; Issued: 03- 16-07; Effective: December 19, 2006; Implementation: 04- 02-07) If this service is not reasonable and necessary under 1862(a)(1)(A) of the Act (falls outside the scope of the revised NCD found in Pub. 100- 03, chapter 1, section 110.4), contractors shall advise physicians and/or hospital outpatient departments, including critical access hospitals (CAHs), that they will be held liable for charges unless the physician and/or hospital has the beneficiary sign an Advance Beneficiary Notice in advance of providing the service. If this service is provided to a hospital inpatient, including CAHs, for a reason unrelated to the admission (outside of the bundled payment) contractors shall advise hospitals billing for inpatient services that they will be held liable for charges unless the hospital has the beneficiary sign a Hospital Issued Notice of Noncoverage letter 11 in advance of providing the service. 200 - Billing Requirements for Vagus Nerve Stimulation (VNS) (Rev. 1271, Issued: 06- 22-07; Effective: 05- 04-07; Implementation: 07 -23-07) 200.1 - General (Rev. 1271, Issued: 06- 22-07; Effective: 05 -04-07; Implementation: 07 -23-07) VNS is a pulse generator, similar to a pacemaker, that is surgically implanted under the skin of the left chest and an electrical lead (wire) is connected from the generator to the left vagus nerve. Electrical signals are sent from the battery -powered gen erator to the vagus nerve via the lead. These signals are in turn sent to the brain. FDA approved VNS for treatment of refractory epilepsy in 1999. Further coverage guidelines can be found in the National Coverage Determination Manual (Publication 100- 03), Chapter 1, Section 160.18. Since the HCPCS codes for VNS can also be used for other indications, contractors must determine if the service being billed are for VNS and make a determination to pay or deny. CMS guidance on payment is listed below. 200.2 - ICD-10 Diagnosis Codes for Vagus Nerve Stimulation (Covered since DOS on and after July 1, 1999) (Rev. 12435, Issued:12- 28-23, Effective:01 -29-24, Implementation:01- 29-24) One of the following diagnosis codes must be reported as appropriate, when billing for Vagus Nerve Stimulation: If ICD- 10-CM is applicable: G40.011 Localization- related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset, intractable, with status epileptic G40.019 Localization- related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset, intractable, without status epilepticus G40.111 Localization- related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures, intractable, with status epilepticus G40.119 Localization- related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures, intractable, without status epilepticus G40.211 Localization- related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures, intractable, with status epilepticus G40.219 Localization- related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures, intractable, without status epilepticus G40.833 Dravet syndrome, intractable, with status epilepticus G40.834 Dravet syndrome, intractable, without status epilepticus G40.C11 Lafora progressive myoclonus epilepsy, intractable, with status epilepticus G40.C19 Lafora progressive myoclonus epilepsy, intractable, without status epilepticus 200.3 - Carrier/MAC Billing Requirements (Rev. 1271, Issued: 06- 22-07; Effective: 05 -04-07; Implementation: 07 -23-07) Effective for services performed on or after July 1, 1999, contractors are accepting claims submitted for vagus nerve stimulation for epilepsy and recurrent seizures. Effective for services performed on or after July 1, 1999, CMS determined that vagus nerve stimulation is not reasonable and necessary for all other types of seizures which are refractory and for whom surgery is not recommended or for whom surgery has fail ed. Effective for services performed on or after May 4, 2007, contractors will deny claims submitted for vagus nerve stimulation for resistant depression. Contractors need to update their local coverage determination policy to include this new NCD determination. There is no coverage for vagus nerve stimulation for patient with resistant depression. 200.4 - Fiscal Intermediary Billing Requirements (Rev. 1271, Issued: 06- 22-07; Effective: 05 -04-07; Implementation: 07 -23-07) Effective for services performed on or after July 1, 1999, contractors are accepting claims submitted for vagus nerve stimulation for epilepsy and recurrent seizures. Effective for services performed on or after July 1, 1999, CMS determined that vagus nerve stimulation is not reasonable and necessary for all other types of seizures which are refractory and for whom surgery is not recommended or for whom surgery has fail ed. Effective for services performed on or after May 4, 2007, contractors will reject claims submitted for vagus nerve stimulation for resistant depression. 200.5 - Medicare Summary Notice (MSN), Remittance Advice Remark Code (RARC) and Claim Adjustment Reason Code (CARC) Messages (Rev.11035, Issued:10 -13-21, Effective: 11-17-21; Implementation: 11-17-21) The following messages are used by Medicare contractors when denying non - covered VNS services: MSN: 16.10 Medicare does not pay for this item or service." CARC: 50 These are non -covered services because this is not deemed a medical necessity by the payer." The following RARC messages can be used depending on liability: M27 Alert: The patient has been relieved of liability of payment of these items and services under the limitation of liability provision of the law. You, the provider, are ultimately liable for the patient's waived charges, including any charges for coinsurance, since the items or services were not reasonable and necessary or constituted custodial care, and you knew or could reasonably have been expected to know, that they were not covered. You may appeal this determination. You may ask for an appeal regarding both the coverage determination and the issue of whether you exercised due care. The appeal request must be filed within 120 days of the date you receive this notice. You must make the request through this office. Or M38 Alert: The patient is liable for the charges for this service as you informed the patient in writing before the service was furnished that we would not pay for it, and the patient agreed to pay. Contractors will also include group code CO (contractual obligation) or PR (patient responsibility) depending on liability. 200.6 - Advance Beneficiary Notice and HINN Information (Rev. 1271, Issued: 06- 22-07; Effective: 05 -04-07; Implementation: 07 -23-07) Physicians are liable for non -covered VNS procedures unless they issue an appropriate advance beneficiary notice (ABN). T he following language should be included in the ABN: Items or Service Section: Vagas Nerve Stimulation. Because Section: As specified in section 160.18 of Pub.100- 03, Medicare National Coverage Determination Manual, Medicare will not pay for this procedure as it is not a reasonable and necessary treatment for (select either your type of seizure disorder or resistant depression.) Note that the ABN is the appropriate notice for Part B services and is valid whether the language above is inserted or not. 210 - Billing Requirements for Continuous Positive Airway Pressure (CPAP) for Obstructive Sleep Apnea (OSA) (Rev.) 220 - Billing Requirements for Thermal Intradiscal Procedures (TIPs) (Rev. 1646, Issued: 12- 09-08, Effective: 09 -29-08, Implementation: 01- 05-09) 220.1 - General (Rev. 1646, Issued: 12- 09-08, Effective: 09 -29-08, Implementation: 01- 05-09) Effective for services on or after September 29, 2008, the Center for Medicare & Medicaid Services (CMS) made the decision that Thermal Intradiscal Procedures (TIPS) are not reasonable and necessary for the treatment of low back pain. Therefore, TIPs are non-covered. Refer to Pub.100- 03, Medicare National Coverage Determination (NCD) Manual Chapter 1, Part 2, Section 150.11, for further information on the NCD. 220.2 - Contractors, A/B Medicare Administrative Contractors (MACs) (Rev. 1646, Issued: 12- 09-08, Effective: 09 -29-08, Implementation: 01- 05-09) The following Healthcare Common Procedure Coding System (HCPCS) codes will be nationally non- covered by Medicare effective for dates of service on and after September 29, 2008: 22526: Percutaneous intradiscal electrothermal annuloplasty, unilateral or bilateral including fluoroscopic guidance; single level 22527: Percutaneous intradiscal electrothermal annuloplasty, unilateral or bilateral including fluoroscopic guidance; one or more additional levels 0062T: Percutaneous intradiscal annuloplasty, any method except electrothermal, unilateral or bilateral including fluoroscopic guidance; single level 0063T: Percutaneous intradiscal annuloplasty, any method except electrothermal, unilateral or bilateral including fluoroscopic guidance; one or more additional levels NOTE: The change to add the non-covered indicator for the above HCPCS codes will be part of the January 2009 Medicare Physician Fee Schedule Update. The change to the status indicator to non-cover the above HCPCS will be part of the January Integrated Outpati ent Code Editor (IOCE) update. Claims submitted with the non -covered HCPCS codes on or after September 29, 2008, will be denied by Medicare contractors. 220.3 - Medicare Summary Notice (MSN), Claim Adjustment Reason Code (CARC), and Remittance Advice Remark Code (RARC) (Rev. 1646, Issued: 12- 09-08, Effective: 09-29-08, Implementation: 01-05-09)

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22527: Percutaneous intradiscal electrothermal annuloplasty, unilateral or bilateral including fluoroscopic guidance; one or more additional levels 0062T: Percutaneous intradiscal annuloplasty, any method except electrothermal, unilateral or bilateral including fluoroscopic guidance; single level 0063T: Percutaneous intradiscal annuloplasty, any method except electrothermal, unilateral or bilateral including fluoroscopic guidance; one or more additional levels NOTE: The change to add the non-covered indicator for the above HCPCS codes will be part of the January 2009 Medicare Physician Fee Schedule Update. The change to the status indicator to non-cover the above HCPCS will be part of the January Integrated Outpati ent Code Editor (IOCE) update. Claims submitted with the non -covered HCPCS codes on or after September 29, 2008, will be denied by Medicare contractors. 220.3 - Medicare Summary Notice (MSN), Claim Adjustment Reason Code (CARC), and Remittance Advice Remark Code (RARC) (Rev. 1646, Issued: 12- 09-08, Effective: 09-29-08, Implementation: 01-05-09) The following messages are used by Medicare contractors when denying non- covered TIP services: MSN: 21.11 This service was not covered by Medicare at the time you received it. CARC: 96 Non-covered charge(s) 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 http://www.cms.hhs.gov/med/search.asp. If you do not have web access, you may contact the contractor to request a copy of the NCD. 220.4 - Advance Beneficiary Notice (ABN) (Rev. 1646, Issued: 12- 09-08, Effective: 09-29-08, Implementation: 01-05-09) Providers are liable for charges if TIPS is used in surgery, unless the beneficiary was informed that he/she would be financially responsible prior to performance of the procedure. To avoid this liability the provider should have the beneficiary sign an AB N. 230 Billing Wrong Surgical or Other Invasive Procedures Performed on a Patient, Surgical or Other Invasive Procedures Performed on the Wrong Body Part, and Surgical or Other Invasive Procedures Performed on the Wrong Patient (Rev. 2998, Issued: 07- 25-14, Effective: Upon implementation of ICD-10; 01-01-12 - ASC X12, Implementation: 08-25-2014 - ASC X12; Upon Implementation of ICD -10) The Centers for Medicare & Medicaid Services (CMS) internally generated a request for a national coverage analysis (NCA) to establish national coverage determinations (NCDs) addressing Medicare coverage of Wrong Surgical or Other Invasive Procedures Performed on a Patient, Surgical or Other Invasive Procedures Performed on the Wrong Body Part, and Surgical or Other Invasive Procedures Performed on the Wrong Patient. Information regarding these NCDs can be found in Publication (Pub.) 100-03, Chapter 1, sections 140.6, 140.7, and 140.8, respectively. Inpatient Claims Hospitals are required to bill two claims when a surgical error is reported and a covered service is also being reported: One claim with covered service(s)/procedure(s) unrelated to the erroneous surgery(s) on a Type of Bill (TOB) 11X (with the exception of 110), and The other claim with the non- covered service(s)/procedure(s) related to the erroneous surgery(s) on a TOB 110 (no- pay claim) NOTE: Both the covered and non- covered claim shall have a matching Statement Covers Period. For discharges prior to October 1, 2009, the non-covered TOB 110 must indicate on the 837 institutional claim format, or in the Remarks field of the Form CMS1450 one of the applicable erroneous surgery(s) two- digit codes (entered exactly as specified below ): For a wrong surgery on patient, enter the following: MX For a surgery on a wrong body part, enter the following: MY For a surgery on wrong patient, enter the following: MZ For discharges on or after October 1, 2009, the non-covered TOB 110 must have one of the following diagnosis codes reported in diagnosis position 2-9, instead of billing the aforementioned two-digit codes in Remarks: If ICD -9-CM Is Applicable E876.5 - Performance of wrong operation (procedure) on correct patient (existing code) E876.6 - Performance of operation (procedure) on patient not scheduled for surgery E876.7- Performance of correct operation (procedure) on wrong side/body part NOTE : The above codes shall not be reported in the External Cause of Injury (E- code) field. If ICD -10-CM Is Applicable Y65.51 Performance of wrong procedure (operation) on correct patient Y65.52 Performance of procedure (operation) on patient not scheduled for surgery Y65.53 Performance of correct procedure (operation) on wrong side of body parts Outpatient, Ambulatory Surgical Centers, and Practitioner Claims Providers are required to append one of the following applicable HCPCS modifiers to all lines related to the erroneous surgery(s): PA: Surgery Wrong Body Part PB: Surgery Wrong Patient PC: Wrong Surgery on Patient All claims Claim/Lines submitted with a surgical error will be denied/line -item denied using the following: Medicare Summary Notice 23.17 Medicare wont cover these services because they are not considered medically necessary. 23.17 Medicare no cubrir estos servicios porque no son considerados necesarios por razones mdicas. Claim Adjustment Reason Code CARC 50 These are non -covered services because this is not deemed a medical necessity by the payer. Group Code CO Contractual Obligation Beneficiary Liability Generally, beneficiary liability notices such an Advance Beneficiary Notice of Non- coverage (ABN) or a Hospital Issued Notice of Non-coverage (HINN) is appropriate when a provider is furnishing an item or service that the provider reasonably believes Medicare will not cover on the basis of 1862(a)(1). An ABN must include all of the elements described in Pub. 100-04, Claims Processing Manual (CPM), Ch. 30, 50.6.3, in order to be considered valid. For example, the ABN must specifically describe the item o r service expected to be denied (e.g. a left leg amputation) and must include a cost estimate for the non -covered item or service. Similarly, HINNs must specifically describe the item or service expected to be denied (e.g. a left leg amputation) and must include all of the elements described in the instructions found in the CPM Ch. 3,0 200. Thus, a provider cannot shift financial liability for the non-covered services to the beneficiary, unless the ABN or the HINN satisfies all of the applicable requirements in the CPM Ch. 30, 50.6.3 and 200, respectively. Given these requirements, CMS cannot envision a scenario in which HINNs or ABNs could be validly delivered in these NCD cases. However, an ABN or a HINN could be validly delivered prior to furnishing services related to the follow -up care for the non-covered surgical error that would not be considered a related service to the non -covered surgical error. 240 Special Instructions for Services with a Gender/Procedure Conflict (Rev. 1877, Issued: 12- 18-09, Effective: 04-01-10, Implementation: 04-05-10) Claims for some services for beneficiaries with transgender, ambiguous genitalia, and hermaphrodite issues, may inadvertently be denied due to sex related edits unless these services are billed properly. The National Uniform Billing Committee (NUBC) has approved condition code 45 (Ambiguous Gender Category) as a result of the increasing number of claims received that are denied due to sex/diagnosis and sex/procedure edits. This claim level condition code should be used by institutional providers to identify these unique claims and alerts the fiscal intermediary that the gender/procedure or gender/diagnosis conflict is not an error allowing the sex related edits to be by- passed. The KX modifier ( Requirements specified in the medical policy have been met ) is now a multipurpose informational modifier and will also be used identify services for transgender, ambiguous genitalia, and hermaphrodite beneficiaries in addition to its other existing uses. Physicians and non-physician practitioners should use modifier KX with procedure codes that are gender specific in the particular cases of transgender, ambiguous genitalia, and hermaphrodite beneficiaries. Therefore, if a gender/procedure or gender/diagnosis conflict edit occurs, the KX modifier alerts the MAC that it is not an error and will allow the claim to continue with normal processing. 240.1 - Billing Instructions for Institutional Providers (Rev. 1877, Issued: 12- 18-09, Effective: 04-01-10, Implementation: 04-05-10) Institutional providers are to report condition code 45 on any inpatient or outpatient claim related to transgender, ambiguous genitalia, or hermaphrodite issues. 240.2 Billing Instructions for Physicians and Non -Physician Practitioners (Rev. 1877, Issued: 12- 18-09, Effective: 04 -01-10, Implementation: 04- 05-10) The KX modifier is to be billed on the detail line only with the procedure code(s) that is gender specific for transgender, ambiguous genitalia, and hermaphrodite beneficiaries. (NOTE: The KX modifier is a multipurpose informational modifier, and may also be used in conjunction with other medical policies.) 250 Pharmacogenomic Testing for Warfarin Response (Rev. 1889, Issued: 01- 08-10; Effective Date: 08 -03-09; Implementation Date: 04- 05-10) 250.1 Coverage Requirements (Rev. 1889, Issued: 01- 08-10; Effective Date: 08 -03-09; Implementation Date: 04- 05-10) Effective August 3, 2009, pharmacogenomic testing to predict warfarin responsiveness is covered only when provided to Medicare beneficiaries who are candidates for anticoagulation therapy with warfarin; i.e., have not been previously tested for CYP2C9 or V KORC1 alleles; and have received fewer than five days of warfarin in the anticoagulation regimen for which the testing is ordered; and only then in the context of a prospective, randomized, controlled clinical study when that study meets certain criteria a s outlined in Pub 100- 03, section 90.1, of the NCD Manual. NOTE: A new temporary HCPCS Level II code effective August 3, 2009, G9143, warfarin responsiveness testing by genetic technique using any method, any number of specimen(s), was developed to enable implementation of CED for this purpose. 250.2 Billing Requirements (Rev. 11021; Issued: 10- 01-21; Effective: 10 -29-21; Implementation: 10 -29-21) Institutional clinical trial claims for pharmacogenomic testing for warfarin response are identified through the presence of all of the following elements: Value Code D4 and 8- digit clinical trial number (when present on the claim) - Refer to Transmittal 310, Change Request 5790, dated January 18, 2008; ICD-10 diagnosis code Z00.6 (secondary) - Refer to Transmittal 310, Change Request 5790, dated January 18, 2008; and Z79.01 (primary); Condition Code 30 - Refer to Transmittal 310, Change Request 5790, dated January 18, 2008; HCPCS modifier Q0: outpatient claims only - Refer to Transmittal 1418, Change Request 5805, dated January 18, 2008; and, HCPCS code G9143 (mandatory with the April 2010 Integrated Outpatient Code Editor (IOCE) and the January 2011 Clinical Laboratory Fee Schedule (CLFS) updates. Prior to these times, any trials should bill FIs for this test as they currently do absent these instructions, and the FIs should process and pay those claims accordingly.) Practitioner clinical trial claims for pharmacogenomic testing for warfarin response are identified through the presence of all of the following elements: ICD-10-diagnosis code Z00.6 (secondary), and ICD -10 diagnosis code Z79.01 (primary) MCS edit 031L70.7; 8-digit clinical trial number(when present on the claim); HCPCS modifier Q0; and, MCS edit 031L

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Condition Code 30 - Refer to Transmittal 310, Change Request 5790, dated January 18, 2008; HCPCS modifier Q0: outpatient claims only - Refer to Transmittal 1418, Change Request 5805, dated January 18, 2008; and, HCPCS code G9143 (mandatory with the April 2010 Integrated Outpatient Code Editor (IOCE) and the January 2011 Clinical Laboratory Fee Schedule (CLFS) updates. Prior to these times, any trials should bill FIs for this test as they currently do absent these instructions, and the FIs should process and pay those claims accordingly.) Practitioner clinical trial claims for pharmacogenomic testing for warfarin response are identified through the presence of all of the following elements: ICD-10-diagnosis code Z00.6 (secondary), and ICD -10 diagnosis code Z79.01 (primary) MCS edit 031L70.7; 8-digit clinical trial number(when present on the claim); HCPCS modifier Q0; and, MCS edit 031L HCPCS code G9143 (to be carrier priced for claims with dates of service on and after August 3, 2009, that are processed prior to the January 2011 CLFS update.) NOTE: This NCD does not determine coverage to identify CYP2C9 or VKORC1 alleles for other purposes beside warfarin responsiveness, nor does it determine national coverage to identify other alleles to predict warfarin responsiveness. These decisions are made at the local MAC level. 250.3 Payment Requirements (Rev. 11021; Issued: 10-01- 21; Effective: 10 -29-21; Implementation: 10-29-21) Beginning April 5, 2010, for claims with dates of service on and after August 3, 2009, the Medicare Shared System will track the number of times a beneficiary receives pharmacogenomic testing for warfarin response. When a claim is received for pharmacogeno mic testing for warfarin response, and the shared system has determined that the beneficiary has already received the test in his/her lifetime, it will generate a Medicare line-item denial and the Medicare contractor will provide the following messages to enforce the one- time limitation for the test: Claim Adjustment Reason Code (CARC) 50 These are non -covered services because this is not deemed a medical necessity by the payer. This change to be effective April 1, 2010: These are non -covered services because this is not deemed a medical necessity by the payer. NOTE: Refer to the 835 Healthcare Policy Identification Segment, if present. Remittance Advice Remark Code (RARC) N362 The number of Days or Units of Service exceeds our acceptable maximum. Group Code CO Contractual Obligation Medicare Summary Notice (MSN) 16.76 This service/item was not covered because you have exceeded the lifetime limit for getting this service/item. (Este servicio/artculo no fue cubierto porque usted ya se ha pasado del lmite permitido de por vida, para recibirlo.). The Medicare shared system and the A/B MACs (B) will also ensure that pharmacogenomic testing for warfarin response is billed in accordance with clinical trial reporting requirements. In other words, the shared system and the A/B MACs (B) will return to provider/return as unprocessable lines for pharmacogenomic testing for warfarin response when said line is not billed with HCPCS modifier Q0 and ICD-10- CM diagnosis code if applicable, ICD -10-CM Z00.6 is not present as a secondary diagnosis. When the system or the A/B MAC (B) initiates the line - item return to provider or returns the claim as unprocessable, the Medicare contractor will respond with the following messages: For a missing Q0 modifier: CARC 4 - The procedure code is inconsistent with the modifier used or a required modifier is missing. For a missing Z00.6 diagnosis code when a HCPCS Q0 modifier is reported with HCPCS G9143: CARC 16 - Claim/service lacks information which is needed for adjudication. At least one Remark Code must be provided (may be comprised of either the NCPDP Reject Reason Code, or Remittance Advice Remark Code that is not an ALERT.) Remark Code M64 - Missing/incomplete/invalid other diagnosis. For either a missing Q0 modifier and/or a missing ICD-10-CM Z00.6 diagnosis code: Group Code CO- Contractual Obligation MSN 16.77 This service/item was not covered because it was not provided as part of a qualifying trial/study. (Este servicio/artculo no fue cubierto porque no estaba incluido como parte de un ensayo clnico/estudio calificado.) 260 - Dermal Injections for Treatment of Facial Lipodystrophy Syndrome (LDS) (Rev. 2105, Issued: 11- 24-10, Effective: 03-23-10, Implementation: 07-06-10) 260.1 Policy (Rev. 2105, Issued: 11- 24-10, Effective: 03-23-10, Implementation: 07-06-10) The Centers for Medicare & Medicaid Services (CMS) received a request for national coverage of treatments for facial lipodystrophy syndrome (LDS) for human immunodeficiency virus (HIV)- infected Medicare beneficiaries. Facial LDS is often characterized by a loss of fat that results in a facial abnormality such as severely sunken cheeks. This fat loss can arise as a complication of HIV and/or highly active antiretroviral therapy. Due to their appearance and stigma of the condition, patients with facial LDS may become depressed, socially isolated, and in some cases may stop their HIV treatments in an attempt to halt or reverse this complication. Effective for claims with dates of service on and after March 23, 2010, dermal injections for facial LDS are only reasonable and necessary using dermal fillers approved by the Food and Drug Administration for this purpose, and then only in HIV- infected beneficiaries who manifest depression secondary to the physical stigmata of HIV treatment. See Pub. 100-03, National Coverage Decision manual, section 250.5, for detailed policy information concerning treatment of LDS. 260.1.1 Hospital Billing Instructions (Rev. 11021; Issued: 10-01- 21; Effective: 10 -29-21; Implementation: 10-29-21) A - Hospital Outpatient Claims For hospital outpatient claims, hospitals must bill covered dermal injections for treatment of facial LDS by having all of the required elements on the claim: 1. A line with HCPCS codes Q2026 or Q2027 with a Line Item Date of service (LIDOS) on or after March 23, 2010, NOTE: Q2027 is replaced with Q2028 effective 1/1/14 as per the 2014 HCPCS update. 2. A line with HCPCS code G0429 with a LIDOS on or after March 23, 2010, 3. If ICD -10-CM is applicable, ICD-10-CM diagnosis codes B20 Human Immunodeficiency Virus (HIV) disease and E88.1 Lipodystrophy, not elsewhere classified The applicable NCD is 250.5 Facial Lipodystrophy. B - Outpatient Prospective Payment System (OPPS) Hospitals or Ambulatory Surgical Centers (ASCs): For line item dates of service on or after March 23, 2010, and until HCPCS codes Q2026 and Q2027 are billable, facial LDS claims shall contain a temporary HCPCS code C9800, instead of HCPCS G0429 and HCPCS Q2026/Q2027, as shown above. NOTE: Q2027 is replaced with Q2028 effective 1/1/14 as per the 2014, HCPCS update. C - Hospital Inpatient Claims Hospitals must bill covered dermal injections for treatment of facial LDS by having all of the required elements on the claim: C. Discharge date on or after March 23, 2010, D. If ICD -10-PCS is applicable, ICD-10-PCS procedure code 3E00XGC Introduction of Other Therapeutic Substance into Skin and Mucous Membrances, External Approach, or E. If ICD -10-CM is applicable on or after 10/01/2015, ICD-10-CM diagnosis codes B20 Human Immunodeficiency Virus [HIV] disease and E88.1 Lipodystrophy not elsewhere classified. A diagnosis code for a comorbidity of depression may also be required for coverage on an outpatient and/or inpatient basis as determined by the individual Medicare contractors policy. 260.2 Billing Instructions (Rev. 2105, Issued: 11- 24-10, Effective: 03-23-10, Implementation: 07-06-10) 260.2.1 Hospital Billing Instructions (Rev. 2998, Issued: 07- 25-14, Effective: Upon implementation of ICD-10; 01-01-12 - ASC X12, Implementation: 08-25-2014 - ASC X12; Upon Implementation of ICD -10) A - Hospital Outpatient Claims For hospital outpatient claims, hospitals must bill covered d ermal injections for treatment of facial LDS by having all of the required elements on the claim: A line with HCPCS codes Q2026 or Q2027 with a Line Item Date of service (LIDOS) on or after March 23, 2010, A line with HCPCS code G0429 with a LIDOS on or after March 23, 2010, If ICD -9-CM is applicable, ICD-9-CM diagnosis codes 042 (HIV) and 272.6 (Lipodystrophy) or, If ICD-10-CM is applicable, ICD -10-CM diagnosis codes B20 Human Immunodeficiency Virus (HIV) disease and E88.1 Lipodystrophy, not elsewhere classified The applicable NCD is 250.5 Facial Lipodystrophy. B - Outpatient Prospective Payment System (OPPS) Hospitals or Ambulatory Surgical Centers (ASCs): For line item dates of service on or after March 23, 2010, and until HCPCS codes Q2026 and Q2027 are billable, facial LDS claims shall contain a temporary HCPCS code C9800, instead of HCPCS G0429 and HCPCS Q2026/Q2027, as shown above. C - Hospital Inpatient Claims Hospitals must bill covered dermal injections for treatment of facial LDS by having all of the required elements on the claim: Discharge date on or after March 23, 2010, If ICD -9-CM is applicable, o ICD-9-CM procedure code 86.99 (other operations on skin and subcutaneous tissue, i.e., injection of filler material), or o ICD-9-CM diagnosis codes 042 (HIV) and 272.6 (Lipodystrophy) If ICD -10-PCS is applicable, o ICD-10-PCS procedure code 3E00XGC Introduction of Other Therapeutic Substance into Skin and Mucous Membrances, External Approach, or o ICD-10-CM diagnosis codes B20 Human Immundodeficiency Virus [HIV] disease and E88.1 Lipodystrophy not elsewhere classified. A diagnosis code for a comorbidity of depression may also be required for coverage on an outpatient and/or inpatient basis as determined by the individual Medicare contractors policy. 260.2.2 Practitioner Billing Instructions (Rev. 11021; Issued: 10-01- 21; Effective: 10 -29-21; Implementation: 10-29-21) Practitioners must bill covered claims for dermal injections for treatment of facial LDS by having all of the required elements on the claim: Performed in a non- facility setting : A line with HCPCS codes Q2026 or Q2027 with a LIDOS on or after March 23, 2010, NOTE : Q2027 is replaced with Q2028 effective 1/1/14 per the 2014 HCPCS update. A line with HCPCS code G0429 with a LIDOS on or after March 23, 2010, 51 If ICD -10-CM applies, diagnosis codes B20 Human Immunodeficiency Virus (HIV) disease and E88.1 (Lipodystrophy not elsewhere classified). Both diagnoses are required on the claim. NOTE: A diagnosis code for a comorbidity of depression may also be required for coverage based on the individual Medicare contractors policy.

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A diagnosis code for a comorbidity of depression may also be required for coverage on an outpatient and/or inpatient basis as determined by the individual Medicare contractors policy. 260.2.2 Practitioner Billing Instructions (Rev. 11021; Issued: 10-01- 21; Effective: 10 -29-21; Implementation: 10-29-21) Practitioners must bill covered claims for dermal injections for treatment of facial LDS by having all of the required elements on the claim: Performed in a non- facility setting : A line with HCPCS codes Q2026 or Q2027 with a LIDOS on or after March 23, 2010, NOTE : Q2027 is replaced with Q2028 effective 1/1/14 per the 2014 HCPCS update. A line with HCPCS code G0429 with a LIDOS on or after March 23, 2010, 51 If ICD -10-CM applies, diagnosis codes B20 Human Immunodeficiency Virus (HIV) disease and E88.1 (Lipodystrophy not elsewhere classified). Both diagnoses are required on the claim. NOTE: A diagnosis code for a comorbidity of depression may also be required for coverage based on the individual Medicare contractors policy. 52 A line with HCPCS code G0429 with a LIDOS on or after March 23, 2010, 53 If ICD -10 CM - applies, ICD -10-CM diagnosis codes B20 Human immunodeficiency Virus (HIV) disease and E88.1 (Lipodystrophy not elsewhere classified). Both diagnoses are required on the claim. NOTE: A diagnosis code for a comorbidity of depression may also be required for coverage based on the individual Medicare contractors policy. 260.3 Claims Processing System Editing (Rev. 11021; Issued: 10- 01-21; Effective: 10 -29-21; Implementation: 10 -29-21) Billing for Services Prior to Medicare Coverage Hospitals and practitioners billing for dermal injections for treatment of facial LDS prior to the coverage date of March 23, 2010, will receive the following messages upon their Medicare denial: Claim Adjustment Reason Code (CARC) 26: Expenses incurred prior to coverage. NOTE: Outpatient hospitals and beneficiaries that received services in a hospital outpatient setting may receive different message as established by their particular Medicare contractor processing the claim.) Medicare beneficiaries whose provider bills Medicare for dermal injections for treatment of facial LDS prior to the coverage date of March 23, 2010, will receive the following Medicare Summary Notice (MSN) message upon the Medicare denial: - This service was not covered by Medicare at the time you received it. (Spanish Version: Este servicio no estaba cubierto por Medicare cuando usted lo recibi .) Billing for Services Not Meeting Comorbidity Coverage Requirements Hospitals and practitioners billing for dermal injections for treatment of facial LDS on patients that do not have a comorbidity of HIV and lipodystrophy (or even depression if deemed required by the Medicare contractor) will receive the following messages upon their Medicare denial: CARC 50: These are non -covered services because this is not deemed a 'medical necessity' by the payer. Note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. 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 http://www.cms.hhs.gov/mcd/search.asp. If you do not have web access, you may contact the contractor to request a copy of the NCD. RARC M64: Missing/incomplete/invalid other diagnosis. Group Code: CO Medicare beneficiaries who do not meet Medicare comorbidity requirements of HIV and lipodystrophy (or even depression if deemed required by the Medicare contractor) and whose provider bills Medicare for dermal injections for treatment of facial LDS will receive the following MSN message upon the Medicare denial: 15.4 - The information provided does not support the need for this service or item. (Spanish Version: La informacin proporcionada no confirma la necesidad para este servicio oculo.) 270 Claims Processing for Implantable Automatic Defibrillators (Rev. 2005, Issued: 7- 23-10, Effective: 8 -31-10, Implementation: 8- 31-10) Coverage Requirements - The implantable automatic defibrillator is an electronic device designed to detect and treat life threatening tachyarrhythmias. The device consists of a pulse generator and electrodes for sensing and defibrillating. See 20.4 - Medicare National Coverage Determinations (NCD) Manual for the complete list of covered indications. 270.1 Coding Requirements for Implantable Automatic Defibrillators (Rev. 2998, Issued: 07- 25-14, Effective: Upon implementation of ICD -10; 01- 01-12 - ASC X12, Implementation: 08- 25-2014 - ASC X12; Upon Implementation of ICD -10) The following are the applicable HCPCS procedure codes for implantable automatic defibrillators: 33240- (Insertion of single or dual chamber pacing cardioverter -defibrillator pulse generator) 33241(Subcutaneous removal of single or dual chamber pacing cardioverter -defibrillator pulse generator) 33243 (Removal of single or dual chamber pacing cardioverter -defibrillator electrode(s); by thoracotomy) 33244 (Removal of single or dual chamber pacing cardioverter -defibrillator electrodes by transvenous extraction) 33249- (Insertion or repositioning of electrode leads(s) for single or dual chamber pacing cardioverter -defibrillator and insertion of pulse generator) For inpatient hospitals claims, if ICD -9 CM is applicable use procedure code 37.94. If ICD -10-PCS is applicable the following applies. More than one ICD -10-PCS code (a cluster) is required. There are two possible clusters: FIRST CLUSTER: Use 1 code from the first list and one code from the second list. Cluster 1 first list: 0JH608Z Insertion of Defibrillator Generator into Chest Subcutaneous Tissue and Fascia, Open Approach 0JH638Z Insertion of Defibrillator Generator into Chest Subcutaneous Tissue and Fascia, Percutaneous Approach 0JH808Z Insertion of Defibrillator Generator into Abdomen Subcutaneous Tissue and Fascia, Open Approach 0JH838Z Insertion of Defibrillator Generator into Abdomen Subcutaneous Tissue and Fascia, Percutaneous Approach Cluster 1 second list: 02H60KZ Insertion of Defibrillator Lead into Right Atrium, Open Approach 02H63KZ Insertion of Defibrillator Lead into Right Atrium, Percutaneous Approach 02H64KZ Insertion of Defibrillator Lead into Right Atrium, Percutaneous Endoscopic Approach 02H70KZ Insertion of Defibrillator Lead into Left Atrium, Open Approach 02H73KZ Insertion of Defibrillator Lead into Left Atrium, Percutaneous Approach 02H74KZ Insertion of Defibrillator Lead into Left Atrium, Percutaneous Endoscopic Approach 02HK0KZ Insertion of Defibrillator Lead into Right Ventricle, Open Approach 02HK3KZ Insertion of Defibrillator Lead into Right Ventricle, Percutaneous Approach 02HK4KZ Insertion of Defibrillator Lead into Right Ventricle, Percutaneous Endoscopic Approach 02HL0KZ Insertion of Defibrillator Lead into Left Ventricle, Open Approach 02HL3KZ Insertion of Defibrillator Lead into Left Ventricle, Percutaneous Approach 02HL4KZ Insertion of Defibrillator Lead into Left Ventricle, Percutaneous Endoscopic Approach SECOND CLUSTER: Use 1 code from 1st list & 1 code from the 4th list; also add one code from each of the 2nd & 3rd lists if doing a replacement instead of initial insertion. Cluster 2 first list: 0JH608Z Insertion of Defibrillator Generator into Chest Subcutaneous Tissue and Fascia, Open Approach 0JH638Z Insertion of Defibrillator Generator into Chest Subcutaneous Tissue and Fascia, Percutaneous Approach 0JH808Z Insertion of Defibrillator Generator into Abdomen Subcutaneous Tissue and Fascia, Open Approach 0JH838Z Insertion of Defibrillator Generator into Abdomen Subcutaneous Tissue and Fascia, Percutaneous Approach Cluster 2 second list: 0JPT0PZ Removal of Cardiac Rhythm Related Device from Trunk Subcutaneous Tissue and Fascia, Open Approach 0JPT3PZ Removal of Cardiac Rhythm Related Device from Trunk Subcutaneous Tissue and Fascia, Percutaneous Approach Cluster 2 third list: 02PA0MZ Removal of Cardiac Lead from Heart, Open Approach 02PA3MZ Removal of Cardiac Lead from Heart, Percutaneous Approach 02PA4MZ Removal of Cardiac Lead from Heart, Percutaneous Endoscopic Approach 02PAXMZ Removal of Cardiac Lead from Heart, External Approach Cluster 2 fourth list: 02H60KZ Insertion of Defibrillator Lead into Right Atrium, Open Approach 02H63KZ Insertion of Defibrillator Lead into Right Atrium, Percutaneous Approach 02H64KZ Insertion of Defibrillator Lead into Right Atrium, Percutaneous Endoscopic Approach 02H70KZ Insertion of Defibrillator Lead into Left Atrium, Open Approach 02H73KZ Insertion of Defibrillator Lead into Left Atrium, Percutaneous Approach 02H74KZ Insertion of Defibrillator Lead into Left Atrium, Percutaneous Endoscopic Approach 02HK0KZ Insertion of Defibrillator Lead into Right Ventricle, Open Approach 02HK3KZ Insertion of Defibrillator Lead into Right Ventricle, Percutaneous Approach 02HK4KZ Insertion of Defibrillator Lead into Right Ventricle, Percutaneous Endoscopic Approach 02HL0KZ Insertion of Defibrillator Lead into Left Ventricle, Open Approach 02HL3KZ Insertion of Defibrillator Lead into Left Ventricle, Percutaneous Approach 02HL4KZ Insertion of Defibrillator Lead into Left Ventricle, Percutaneous Endoscopic Approach 270.2 Billing Requirements for Patients Enrolled in a Data Collection System (Rev.11759, Issued:12- 21-2022, Effective:01 -23-2023, Implementation:01- 23-2023) Effective for dates of service on or after April 1, 2005, Medicare required that patients receiving a defibrillator for the primary prevention of sudden cardiac arrest be enrolled in a qualifying data collection system. Providers shall use modifier Q0 to identify patients whose data is being submitted to a data collection system. The following diagnosis codes identify non -primary prevention (secondary prevention) patient or replacement implantations (e.g. due to recalled devices): If ICD -9-CM is applicable, select from the following diagnosis codes: 427.1 Ventricular tachycardia 427.41 Ventricular fibrillation 427.42 Ventricular flutter 427.5 Cardiac arrest 427.9 Cardiac dysrhythmia, unspecified V12.53 Personal history of sudden cardiac arrest 996.04 Mechanical complication of cardiac device, implant, and graft, due to automatic implantable cardiac defibrillator V53.32 Fitting and adjustment of other device, automatic implantable cardiac defibrillator

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270.2 Billing Requirements for Patients Enrolled in a Data Collection System (Rev.11759, Issued:12- 21-2022, Effective:01 -23-2023, Implementation:01- 23-2023) Effective for dates of service on or after April 1, 2005, Medicare required that patients receiving a defibrillator for the primary prevention of sudden cardiac arrest be enrolled in a qualifying data collection system. Providers shall use modifier Q0 to identify patients whose data is being submitted to a data collection system. The following diagnosis codes identify non -primary prevention (secondary prevention) patient or replacement implantations (e.g. due to recalled devices): If ICD -9-CM is applicable, select from the following diagnosis codes: 427.1 Ventricular tachycardia 427.41 Ventricular fibrillation 427.42 Ventricular flutter 427.5 Cardiac arrest 427.9 Cardiac dysrhythmia, unspecified V12.53 Personal history of sudden cardiac arrest 996.04 Mechanical complication of cardiac device, implant, and graft, due to automatic implantable cardiac defibrillator V53.32 Fitting and adjustment of other device, automatic implantable cardiac defibrillator If ICD -10-CM is applicable, select from the following list: I47.0 Re -entry Ventricular Arrhythmia I47.2 Ventricular Tachycardiaselect - end date September 30, 2022 I47.20 Ventricular Tachycardia, unspecified - effective October 1, 2022 I47.21 Torsades De Pointes - effective October 1, 2022 I47.29 Other Ventricular Tachycardia - effective October 1, 2022 I49.3 Ventricular Premature depolarization I49.01 Ventricular Fibrillation I49.02 Ventricular Flutter I46.2 Cardiac arrest due to underlying cardiac condition I46.8 Cardiac arrest due to other underlying condition I46.9 Cardiac arrest, cause unspecified I49.9 Cardiac arrhythmia, unspecified T82.110A Breakdown (mechanical) of cardiac electrode, initial encounter T82.111A Breakdown (mechanical) of cardiac pulse generator (battery), initial encounter T82.118A Breakdown (mechanical) of other cardiac electronic device, initial encounter T82.119A Breakdown (mechanical) of unspecified cardiac electronic device, initial encounter T82.120A Displacement of cardiac electrode, initial encounter T82.121A Displacement of cardiac pulse generator (battery), initial encounter T82.128A Displacement of other cardiac electronic device, initial encounter T82.129A Displacement of unspecified cardiac electronic device, initial encounter T82.190A Other mechanical complication of cardiac electrode, initial encounter T82.191A Other mechanical complication of cardiac pulse generator (battery), initial encounter T82.198A Other mechanical complication of other cardiac electronic device, initial encounter T82.199A Other mechanical complication of unspecified cardiac device, initial encounter Z86.74 Personal history of sudden cardiac arrest Z45.02 Encounter for adjustment and management of automatic implantable cardiac defibrillator When any of the above codes appear on a claim, the Q0 modifier is not required. The Q0 modifier may be appended to claims for secondary prevention indications when data is being entered into a qualifying data collection system. 280 - Autologous Cellular Immunotherapy Treatment of Prostate Cancer (Rev. 2380, Issued: 01- 06-12, Effective: 06 -30-11, Implementation: 08- 08-11) 280.1 - Policy (Rev. 2380, Issued: 01- 06-12, Effective: 06 -30-11, Implementation: 08- 08-11) Effective for services furnished on or after June 30, 2011, a National Coverage Determination (NCD) provides coverage of sipuleucel -T (PROVENGE) for patients with asymptomatic or minimally symptomatic metastatic, castrate -resistant (hormone refractory) pr ostate cancer. Conditions of Medicare Part A and Medicare Part B coverage for sipuleucel -T are located in the Medicare NCD Manual, Publication 100- 03, section 110.22. 280.2 - Healthcare Common Procedure Coding System (HCPCS) Codes and Diagnosis Coding (Rev. 2380, Issued: 01- 06-12, Effective: 06 -30-11, Implementation: 08- 08-11) HCPCS Codes Effective for claims with dates of service on June 30, 2011, Medicare providers shall report one of the following HCPCS codes for PROVENGE: C9273 - Sipuleucel -T, minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF, including leukapheresis and all other preparatory procedures, per infusion, or J3490 Unclassified Drugs, or J3590 Unclassified Biologics. NOTE : Contractors shall continue to process claims for HCPCS code C9273, J3490, and J3590, with dates of service June 30, 2011, as they do currently. Effective for claims with dates of service on and after July 1, 2011, Medicare providers shall report the following HCPCS code: Q2043 Sipuleucel -T, minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF, including leukapheresis and all other preparatory procedures, per infusion; short descriptor, Sipuleucel -T auto CD54+. ICD- 9 Diagnosis Coding For claims with dates of service on and after July 1, 2011, for PROVENGE, the on- label indication of asymptomatic or minimally symptomatic metastatic, castrate -resistant (hormone refractory) prostate cancer, must be billed using ICD -9 code 185 (malignant neoplasm of prostate) and at least one of the following ICD -9 codes: ICD- 9 code Description 196.1 Secondary and unspecified malignant neoplasm of intrathoracic lymph nodes 196.2 Secondary and unspecified malignant neoplasm of intra -abdominal lymph nodes 196.5 Secondary and unspecified malignant neoplasm of lymph nodes of inguinal region and lower limb 196.6 Secondary and unspecified malignant neoplasm of intrapelvic lymph nodes 196.8 Secondary and unspecified malignant neoplasm of lymph nodes of multiple sites 196.9 Secondary and unspecified malignant neoplasm of lymph node site unspecified - The spread of cancer to and establishment in the lymph nodes. 197.0 Secondary malignant neoplasm of lung Cancer that has spread from the original (primary) tumor to the lung. The spread of cancer to the lung. This may be from a primary lung cancer, or from a cancer at a distant site. 197.7 Malignant neoplasm of liver secondary - Cancer that has spread from the original (primary) tumor to the liver. A malignant neoplasm that has spread to the liver from another (primary) anatomic site. Such malignant neoplasms may be carcinomas (e.g., breast, colon), lymphomas, melanomas, or sarcom as. 198.0 Secondary malignant neoplasm of kidney - The spread of the cancer to the kidney. This may be from a primary kidney cancer involving the opposite kidney, or from a cancer at a distant site. 198.1 Secondary malignant neoplasm of other urinary organs 198.5 Secondary malignant neoplasm of bone and bone marrow Cancer that has spread from the original (primary) tumor to the bone. The spread of a malignant neoplasm from a primary site to the skeletal system. The majority of metastatic neoplasms to the bone are carcinomas. 198.7 Secondary malignant neoplasm of adrenal gland 198.82 Secondary malignant neoplasm of genital organs Coding for Off -Label PROVENGE Services The use of PROVENGE off -label for the treatment of prostate cancer is left to the discretion of the Medicare Administrative Contractors. Claims with dates of service on and after July 1, 2011, for PROVENGE paid off -label for the treatment of prostate ca ncer must be billed using either ICD -9 code 233.4 (carcinoma in situ of prostate), or ICD -9 code 185 (malignant neoplasm of prostate) in addition to HCPCS Q2043. Effective with the implementation date for ICD -10 codes, off -label PROVENGE services must be billed with either ICD -10 code D075(carcinoma in situ of prostate), or C61 (malignant neoplasm of prostate) in addition to HCPCS Q2043. ICD- 10 Diagnosis Coding Contractors shall note the appropriate ICD -10 code(s) that are listed below for future implementation. Contractors shall track the ICD -10 codes and ensure that the updated edit is turned on as part of the ICD -10 implementation effective October 1, 2013. ICD- 10 Description C61 Malignant neoplasm of prostate (for on -label or off -label indications) D075 Carcinoma in situ of prostate (for off -label indications only) C77.1 Secondary and unspecified malignant neoplasm of intrathoracic lymph nodes C77.2 Secondary and unspecified malignant neoplasm of intra -abdominal lymph nodes C77.4 Secondary and unspecified malignant neoplasm of inguinal and lower limb lymph nodes C77.5 Secondary and unspecified malignant neoplasm of intrapelvic lymph nodes C77.8 Secondary and unspecified malignant neoplasm of lymph nodes of multiple regions C77.9 Secondary and unspecified malignant neoplasm of lymph node, unspecified C78.00 Secondary malignant neoplasm of unspecified lung C78.01 Secondary malignant neoplasm of right lung C78.02 Secondary malignant neoplasm of left lung C78.7 Secondary malignant neoplasm of liver C79.00 Secondary malignant neoplasm of unspecified kidney and renal pelvis C79.01 Secondary malignant neoplasm of right kidney and renal pelvis C79.02 Secondary malignant neoplasm of left kidney and renal pelvis C79.10 Secondary malignant neoplasm of unspecified urinary organs C79.11 Secondary malignant neoplasm of bladder C79.19 Secondary malignant neoplasm of other urinary organs C79.51 Secondary malignant neoplasm of bone C79.52 Secondary malignant neoplasm of bone marrow C79.70 Secondary malignant neoplasm of unspecified adrenal gland C79.71 Secondary malignant neoplasm of right adrenal gland C79.72 Secondary malignant neoplasm of left adrenal gland C79.82 Secondary malignant neoplasm of genital organs 280.3 - Types of Bill (TOB) and Revenue Codes (Rev. 2380, Issued: 01- 06-12, Effective: 06 -30-11, Implementation: 08- 08-11) The applicable TOBs for PROVENGE are: 12X, 13X, 22X, 23X, 71X, 77X, and 85X. On institutional claims, TOBs 12X, 13X, 22X, 23X, and 85X, use revenue code 0636 - drugs requiring detailed coding. 280.4 - Payment Method (Rev. 2380, Issued: 01- 06-12, Effective: 06 -30-11, Implementation: 08 -08-11) Payment for PROVENGE is as follows: TOBs 12X, 13X, 22X and 23X - based on the Average Sales Price (ASP) + 6%, TOB 85X based on reasonable cost, TOBs 71X and 77X based on all -inclusive rate. For Medicare Part B practitioner claims, payment for PROVENGE is based on ASP + 6%. Contractors shall not pay separately for routine costs associated with PROVENGE, HCPCS Q2043, except for the cost of administration. (Q2043 is all -inclusive and represents all routine costs except for its cost of administration). 280.5 - Medicare Summary Notices (MSNs), Remittance Advice Remark Codes (RARCs), Claim Adjustment Reason Codes (CARCs), and Group Codes (Rev. 2394, Issued: 01- 25-12, Effective: 06 -30-11 for -(claims with dates of service on or after 07 -01- 11 processed on or after July 02- 12, Implementation: 07- 02-12) Contractors shall use the following messages when denying claims for the on- label indication for PROVENGE, HCPCS Q2043, submitted without ICD -9-CM diagnosis code 185 and at least one diagnosis code from the ICD -9 table in Section 280.2 above: MSN 14.9 - Medicare cannot pay for this service for the diagnosis shown on the claim.

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Contractors shall not pay separately for routine costs associated with PROVENGE, HCPCS Q2043, except for the cost of administration. (Q2043 is all -inclusive and represents all routine costs except for its cost of administration). 280.5 - Medicare Summary Notices (MSNs), Remittance Advice Remark Codes (RARCs), Claim Adjustment Reason Codes (CARCs), and Group Codes (Rev. 2394, Issued: 01- 25-12, Effective: 06 -30-11 for -(claims with dates of service on or after 07 -01- 11 processed on or after July 02- 12, Implementation: 07- 02-12) Contractors shall use the following messages when denying claims for the on- label indication for PROVENGE, HCPCS Q2043, submitted without ICD -9-CM diagnosis code 185 and at least one diagnosis code from the ICD -9 table in Section 280.2 above: MSN 14.9 - Medicare cannot pay for this service for the diagnosis shown on the claim. Spanish Version - Medicare no puede pagar por este servicio debido al diagnstico indicado en la reclamacin. RARC 167 - This (these) diagnosis (es) are not covered. Note: Refer to the 835 Healthcare Policy Identification segment (loop 2110 Service Payment Information REF), if present. Group Code CO (Contractual Obligation) Contractors shall use the following messages when denying claims for the off -label indication for PROVENGE, HCPCS Q2043, submitted without ICD -9-CM diagnosis code 233.4: MSN 14.9 - Medicare cannot pay for this service for the diagnosis shown on the claim. Spanish Version - Medicare no puede pagar por este servicio debido al diagnstico indicado en la reclamacin. RARC 167 - This (these) diagnosis (es) are not covered. Note: Refer to the 835 Healthcare Policy Identification segment (loop 2110 Service Payment Information REF), if present. Group Code CO (Contractual Obligation) For claims with dates of service on or after July 1, 2012, processed on or after July 2, 2012, when denying claims for PROVENGE, HCPCS Q2043 that exceed three (3) services in a patients lifetime, contractors shall use the following messages: MSN 20.5 - These services cannot be paid because your benefits are exhausted at this time. Spanish Version - Estos servicios no pueden ser pagados porque sus beneficios se han agotado. RARC N362 - The number of Days or Units of Service exceeds our acceptable maximum. CARC 149 - Lifetime benefit maximum has been reached for this service/benefit category. Group Code CO ( Contractual Obligation) 290 Transcatheter Aortic Valve Replacement (TAVR) (Rev. 10179, Issued: 06 -10-20, Effective: 06 -21-19, Implementation: 06- 12-20) Transcatheter aortic valve replacement (TAVR - also known as TAVI or transcatheter aortic valve implantation) is used in the treatment of aortic stenosis. A bioprosthetic valve is inserted percutaneously using a catheter and implanted in the orifice of the aortic valve. The most recent reconsideration of the TAVR policy is effective for claims with dates of service on and after June 21, 2019. It makes changes to the criteria for the heart team and the hospital, and to the trial outcomes and the registry questions/criteria . Please see Publication 100-03, National Coverage Determination Manual Part 1, section 20.32, for complete national policy criteria. HISTORICAL NOTE: CR 7897, Transmittal (TR) 2552, issued September 24, 2012, implemented the initial NCD for TAVR, effective May 1, 2012. CR 8168, TR 2628, issued January 7, 2013, implemented replacement coding to TAVR effective January 1, 2013. CR 8255, TR 2737, issued July 11, 2013, implemented clinical trial number reporting effective July 1, 2013. CR 8537, TR 2827, issued November 29, 2013, implemented replacement CPT coding effective January 1, 2013. 290.1 Coding Requirements for TAVR Furnished on or After May 1, 2012, through December 31, 2012 (Rev. 10179, Issued: 06 -10-20, Effective: 06 -21-19, Implementation: 06- 12-20) The following are the applicable Current Procedural Terminology (CPT) codes for TAVR: 0256T: Implantation of catheter -delivered prosthetic aortic heart valve; endovascular approach 0257T: Implantation of catheter -delivered prosthetic aortic heart valve; open thoracic approach (eg, transapical, transventricular) 0258T: Transthoracic cardiac exposure (i.e. sternotomy, thoracotomy, subxiphoid) for catheter -delivered aortic valve replacement; without cardiopulmonary bypass 0259T: Transthoracic cardiac exposure (i.e. sternotomy, thoracotomy, subxiphoid) for catheter -delivered aortic valve replacement; with cardiopulmonary bypass The following are the International Classification of Diseases (ICD) -9 procedure codes applicable for TAVR: 35.05: Endovascular replacement of aortic valve 35.06: Transapical replacement of aortic valve The following are the ICD -10 procedure codes applicable for TAVR: 35.05: 02RF37Z, 02RF38Z. 02RF3JZ, 02RF3KZ 35.06: 02RF37H, 02RF38H, 02RF3JH, 02RF3KH 290.1.1 - Coding Requirements for TAVR Services Furnished on or After January 1, 2013 (Rev. 10179, Issued: 06 -10-20, Effective: 06 -21-19, Implementation: 06- 12-20) Beginning January 1, 2013, the following are the applicable CPT codes for TAVR: 33361 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; percutaneous femoral artery approach 33362 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open femoral approach 33363 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open axillary artery approach 33364 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open iliac artery approach 33365 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transaortic approach (e.g., median sternotomy, mediastinotomy) 0381T Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transapical approach (e.g., left thoracotomy) Beginning January 1, 2014, temporary CPT code 0318T above is retired. TAVR claims with dates of service on and after January 1, 2014, shall instead use permanent CPT code 33366. 290.2 - Claims Processing Requirements for TAVR Services on Professional Claims (Rev. 10179, Issued: 06 -10-20, Effective: 06-21-19, Implementation: 06-12-20) Place of Service (POS) Professional Claims Effective for claims with dates of service on and after May 1, 2012, place of service (POS) code 21 shall be used for TAVR services. All other POS codes shall be denied. The following messages shall be used when Medicare contractors deny TAVR claims for POS: Claim Adjustment Reason Code (CARC) 58: Treatment was deemed by the payer to have been rendered in an inappropriate or invalid place of service. NOTE: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), i f present. Remittance advice remark code (RARC) N428: Not covered when performed in this place of service. Beginning January 2, 2020, contractors shall no longer report RARC N428 for claims denied for invalid POS. Medicare Summary Notice (MSN) 21.25: This service was denied because Medicare only covers this service in certain settings. Spanish Version: El servicio fue denegado porque Medicare solamente lo cubre en ciertas situaciones." Professional Claims Modifier -62 For TAVR claims with dates of service on or after July 1, 2013, contractors shall pay claim lines with 33361, 33362, 33363, 33364, 33365 & 0318T only when billed with modifier -62. Claim lines billed without modifier -62 shall be returned as unprocessable. Beginning January 1, 2014, temporary CPT code 0318T above is retired. TAVR claims with dates of service on and after January 1, 2014 shall instead use permanent CPT code 33366. The following messages shall be used when Medicare contractors return TAVR claims billed without modifier -62 as unprocessable: CARC 4: The procedure code is inconsistent with the modifier used or a required modifier is missing. Note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. RARC N29: Missing documentation/orders/notes/summary/report/chart. Beginning January 2, 2020, contractors shall no longer report RARC N29 on remittance for claims billed without modifier -62 and returned as unprocessable. RARC MA130: Your claim contains incomplete and/or invalid information, and no appeal rights are afforded because the claim is unprocessable. Please submit a new claim with the complete/correct information. Professional Claims Modifier - Q0 For claims with dates of service on or after January 1 , 2013, contractors shall pay TAVR claim lines for 33361, 33362, 33363, 33364, 33365 & 0318T when billed with modifier-Q0. Claim lines billed without modifier -Q0 shall be returned as unprocessable. Beginning January 1, 2014, temporary CPT code 0318T above is retired. TAVR claims with dates of service on and after January 1, 2014, shall instead use permanent CPT code 33366. The following messages shall be used when Medicare contractors return TAVR claims billed without modifier -Q0 as unprocessable: CARC 4: The procedure code is inconsistent with the modifier used or a required modifier is missing. Note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. RARC N29: Missing documentation/orders/notes/summary/report/chart. Beginning January 2, 2020, contractors shall no longer report RARC N29 on remittance for claims billed without modifier Q0 and returned as unprocessable. RARC MA130: Your claim contains incomplete and/or invalid information, and no appeal rights are afforded because the claim is unprocessable. Please submit a new claim with the complete/correct information. Diagnosis Coding For claims with dates of service on or after July 1, 2013, contractors shall pay TAVR claim lines for 33361, 33362, 33363, 33364, 33365 & 0318T when billed with diagnosis code V70.7 (ICD-10 Z00.6). Claim lines billed without diagnosis code V70.7 (ICD-10 Z00.6) shall be returned as unprocessable. Beginning January 1, 2014, temporary CPT code 0318T above is retired. TAVR claims with dates of service on and after January 1, 2014 shall instead use permanent CPT code 33366. The following messages shall be used when Medicare contractors return TAVR claims billed without diagnosis code V70.7 (ICD-10 Z00.6) as unprocessable: CARC 16: Claim/service lacks information which is needed for adjudication. At least one Remark Code must be provided (may be comprised of either the NCPDP Reject Reason Code, or Remittance Advice Remark Code that is not an ALERT). RARC M76: Missing/incomplete/invalid diagnosis or condition RARC MA130: Your claim contains incomplete and/or invalid information, and no appeal rights are afforded because the claim is unprocessable. Please submit a new claim with the complete/correct information.

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Beginning January 1, 2014, temporary CPT code 0318T above is retired. TAVR claims with dates of service on and after January 1, 2014 shall instead use permanent CPT code 33366. The following messages shall be used when Medicare contractors return TAVR claims billed without diagnosis code V70.7 (ICD-10 Z00.6) as unprocessable: CARC 16: Claim/service lacks information which is needed for adjudication. At least one Remark Code must be provided (may be comprised of either the NCPDP Reject Reason Code, or Remittance Advice Remark Code that is not an ALERT). RARC M76: Missing/incomplete/invalid diagnosis or condition RARC MA130: Your claim contains incomplete and/or invalid information, and no appeal rights are afforded because the claim is unprocessable. Please submit a new claim with the complete/correct information. Group Code Contractual Obligation (CO): Beginning January 2, 2020, contractors shall no longer report Group Code CO on remittances for claims billed without ICD -10 dx Z00.6 and returned as unprocessable. MSN 16.77: This service/item was not covered because it was not provided as part of a qualifying trial/study. Spanish version: Este servicio/articulo no fue cubierto porque no estaba incluido como parte de un ensavo clinic/studio calificado. Beginning January 2, 2020, contractors shall no longer report MSN 16.77 on remittances for claims billed without ICD-10 diagnosis Z00.6 and returned as unprocessable. Professional Claims 8 -digit ClinicalTrials.gov Identifier Number For claims with dates of service on or after July 1, 2013, contractors shall pay TAVR claim lines for 33361, 33362, 33363, 33364, 33365 & 0318T when billed with the numeric, 8- digit clinicaltrials.gov identifier number preceded by the two alpha characters CT when placed in Field 19 of paper Form CMS-1500, or when entered without the CT prefix in the electronic 837P in Loop 2300REF02(REF01=P4). Claim lines billed without an 8- digit clinicaltrials.gov identifier number shall be returned as unprocessable. Beginning January 1, 2014, temporary CPT code 0318T above is retired. TAVR claims with dates of service on and after January 1, 2014 shall instead use permanent CPT code 33366. The following messages shall be used when Medicare contractors return TAVR claims billed without an 8-digit clinicaltrials.gov identifier number as unprocessable: CARC 16: Claim/service lacks information which is needed for adjudication. At least one Remark Code must be provided (may be comprised of either NCPDP Reject Reason Code, or Remittance Advice Remark Code that is not an ALERT). RARC MA50: Missing/incomplete/invalid Investigational Device Exemption number for FDA -approved clinical trial services. RARC MA130: Your claim contains incomplete and/or invalid information, and no appeal rights are afforded because the claim is unprocessable. Please submit a new claim with the complete/correct information. NOTE: Clinicaltrials.gov identifier numbers for TAVR are listed on our website: (http://www.cms.gov/Medicare/Coverage/Coverage- with-Evidence-Development/Transcatheter -Aortic -Valve -Replacement -TAVR -.html) 290.3 - Claims Processing Requirements for TAVR Services on Inpatient Hospital Claims (Rev. 10179, Issued: 06 -10-20, Effective: 06-21-19, Implementation: 06-12-20) Inpatient hospitals shall bill for TAVR on an 11X TOB effective for discharges on or after May 1, 2012. Refer to Section 69 of this chapter for further guidance on billing under CED. Inpatient hospital discharges for TAVR shall be covered when billed with: ICD -9 V70.7 through September 30, 2015, ICD -10 Z00.6 for dates of service on or after October 1, 2015. and Condition Code 30. An 8- digit clinicaltrials.gov identifier number listed on the CMS website (effective July 1, 2013) Inpatient hospital discharges for TAVR shall be rejected when billed without: ICD -9 V70.7 through September 30, 2015, ICD -10 Z00.6 for dates of service on or after October 1, 2015, and Condition Code 30. An 8- digit clinicaltrials.gov identifier number listed on the CMS website (effective July 1, 2013) Claims billed by hospitals not participating in the trial/registry shall be rejected with the following messages: 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 http://www.cms.hhs.gov/mcd/search.asp. If you do not have web access, you may contact the contractor to request a copy of the NCD. Group Code:Contractual Obligation (CO) MSN 16.77: This service/item was not covered because it was not provided as part of a qualifying trial/study. Spanish version: Este servicio/artculo no fue cubierto porque no estaba incluido como parte de un ensayo clnico/estudio calificado. 290.4 - Claims Processing Requirements for TAVR Services for Medicare Advantage (MA) Plan Participants (Rev. 3898, Issued: 10- 27-17; Effective: 04 -01- 15, Implementation: 04- 02-18) MA plans are responsible for payment of TAVR services for MA plan participants. Medicare coverage for TAVR is not included under section 310.1 of the NCD Manual (Routine Costs in Clinical Trials). 300 Billing Requirements for Ocular Photodynamic Therapy (OPT) with Verteporfin (Rev. 2728, Issued: 06- 14-13-Effective: 04 -03-13, Implementation: 07- 16-13) Ocular Photodynamic Therapy (OPT) is used in the treatment of ophthalmologic diseases; specifically, for age -related macular degeneration (AMD), a common eye disease among the elderly. OPT involves the infusion of an intravenous photosensitizing drug calle d Verteporfin, followed by exposure to a laser. For complete Medical coverage guidelines, see National Coverage Determinations (NCD) Manual (Pub 100- 03) 80.2 through 80.3.1. 300.1 - Coding Requirements for OPT with Verteporfin (Rev. 2728, Issued: 06- 14-13, Effective: 04 -03-13, Implementation: 07- 16-13) The following are applicable Current Procedural Terminology (CPT) codes for OPT with Verteporfin: 67221 - Destruction of localized lesion of choroid (e.g. choroidal neovascularization); photodynamic therapy (includes intravenous infusion) 67225- Destruction of localized lesion of choroid (e.g. choroidal neovascularization); photodynamic therapy, second eye, at single session (List separately in addition to code for primary eye treatment) The following are applicable Healthcare Common Procedure Coding System (HCPCS) code for OPT with Verteporfin: J3396- Injection, Verteporfin, 0.1 mg 300.2 - Claims Processing Requirements for OPT with Verteporfin Services on Professional Claims and Outpatient Facility Claims (Rev. 11021; Issued: 10- 01-21; Effective: 10 -29-21; Implementation: 10 -29-21) OPT with Verteporfin is a covered service when billed with the below ICD -10-CM codes Nationally Covered ICD -10-CM codes H35.3210 Exudative age -related macular degeneration, right eye, stage unspecified H35.3211 Exudative age -related macular degeneration, right eye, with active choroidal neovascularization H35.3212 Exudative age -related macular degeneration, right eye, with inactive choroidal neovascularization H35.3213 Exudative age -related macular degeneration, right eye, with inactive scar H35.3220 Exudative age -related macular degeneration, left eye, stage unspecified H35.3221 Exudative age -related macular degeneration, left eye, with active choroidal neovascularization H35.3222 Exudative age -related macular degeneration, left eye, with inactive choroidal neovascularization H35.3223 Exudative age -related macular degeneration, left eye, with inactive scar H35.3230 Exudative age -related macular degeneration, bilateral, stage unspecified H35.3231 Exudative age -related macular degeneration, bilateral, with active choroidal neovascularization H35.3232 Exudative age -related macular degeneration, bilateral, with inactive choroidal neovascularization H35.3233 Exudative age -related macular degeneration, bilateral, with inactive scar ICD- 10- Codes for OPT with Verteporfin for other ocular indications are eligible for local coverage determinations through individual contractor discretion. B39.4 Histocapsulati, unspecified (Translates to combination of both B39.4 & H32) B39.5 Histoplasmosis duboisii (Requires H32 coverage) B39.9 Histoplasmosis, unspecified (Requires H32 coverage) H32 Chorioretinal disorders in diseases classified elsewhere (Requires B39.4 coverage) H44.2A1 Degenerative myopia with choroidal neovascularization, right eye H44.2A2 Degenerative myopia with choroidal neovascularization, left eye H44.2A3 Degenerative myopia with choroidal neovascularization, bilateral eye H44.2B1 Degenerative myopia with macular hole, right eye H44.2B2 Degenerative myopia with macular hole, left eye H44.2B3 Degenerative myopia with macular hole, bilateral eye H44.2C1 Degenerative myopia with retinal detachment, right eye H44.2C2 Degenerative myopia with retinal detachment, left eye H44.2C3 Degenerative myopia with retinal detachment, bilateral eye H44.2D1 Degenerative myopia with foveoschisis, right eye H44.2D2 Degenerative myopia with foveoschisis, left eye H44.2D3 Degenerative myopia with foveoschisis, bilateral eye H44.2E1 Degenerative myopia with other maculopathy, right eye H44.2E2 Degenerative myopia with other maculopathy, left eye H44.2E3 Degenerative myopia with other maculopathy, bilateral eye H44.21 Degenerative Myopia, right eye H44.22 Degenerative Myopia, left eye H44.23 Degenerative Myopia, bilateral H35.711 Central serous chorioretinopathy, right eye H35.712 Central serous chorioretinopathy, left eye H35.713 Central serous chorioretinopathy, bilateral Coverage is denied when billed with the below Nationally Non- Covered ICD -10-CM codes Nationally Non -Covered ICD -10-CM codes:

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Coverage is denied when billed with the below Nationally Non- Covered ICD -10-CM codes Nationally Non -Covered ICD -10-CM codes: H35.30 Unspecified macular degeneration H35.3110 Nonexudative age-related macular degeneration, right eye, stage unspecified H35.3111 Nonexudative age -related macular degeneration, right eye, early dry stage H35.3112 Nonexudative age -related macular degeneration, right eye, intermediate dry stage H35.3113 Nonexudative age -related macular degeneration, right eye, advanced atrophic without subfoveal involvement H35.3114 Nonexudative age -related macular degeneration, right eye, advanced atrophic with subfoveal involvement H35.3120 Nonexudative age -related macular degeneration, left eye, stage unspecified H35.3121 Nonexudative age -related macular degeneration, left eye, early dry stage H35.3122 Nonexudative age -related macular degeneration, left eye, intermediate dry stage H35.3123 Nonexudative age-related macular degeneration, left eye, advanced atrophic without subfoveal involvement H35.3124 Nonexudative age -related macular degeneration, left eye, advanced atrophic with subfoveal involvement H35.3130 Nonexudative age -related macular degeneration, bilateral, stage unspecified H35.3131 Nonexudative age -related macular degeneration, bilateral, early dry stage H35.3132 Nonexudative age -related macular degeneration, bilateral, intermediate dry stage H35.3133 Nonexudative age -related macular degeneration, bilateral, advanced atrophic without subfoveal involvement H35.3134 Nonexudative age -related macular degeneration, bilateral, advanced atrophic with subfoveal involvement Payment for OPT service (CPT code 67221/67225) must be billed on the same claim as the drug (J3396) for the same date of service. Claims for OPT with Verteporfin for dates of service prior to April 3, 2013 are covered at the initial visit as determined by a fluorescein angiogram (FA) CPT code 92235 . Subsequent follow -up visits also require a FA prior to treatment. For claims with dates of service on or after April 3, 2013, contractors shall accept and process claims for subsequent follow -up visits with either a FA, CPT code 92235, or optical coherence tomography (OCT), CPT codes 92133 or 92134, prior to treatment. Regardless of the date of service of the claim, the FA or OCT is not required to be submitted on the claim for OPT and can be maintained in the patients file for audit purposes. 300.3 - Claims Processing Requirements for OPT with Verteporfin Services on Inpatient Facility Claims (Rev. 11021; Issued: 10- 01-21; Effective: 10 -29-21; Implementation: 10 -29-21) Inpatient facilities shall report ICD -10-CM codes H35.3210- H35.3233 (Exudative Age -related Macular Degeneration) and ICD -10-PCS codes 085E3ZZ (Destruction of Right Retina, Percutaneous Approach) and 085F3ZZ (Destruction of Left Retina, Percutaneous Approac h) 300.4 - Medicare Summary Notice (MSN) and Remittance Advice (RA) Messages (Rev. 2728, Issued: 06- 14-13, Effective: 04 -03-13, Implementation: 07- 16-13) The following message shall be used to notify beneficiaries and providers of denial situations that may occur: MSN 14.9: Medicare cannot pay for this service for the diagnosis shown on the claim. (English version) or Medicare no puede pagar por este servicio debido al diagnostic indicado en la reclamacion. (Spanish Version) Claims Adjustment Reason Code B22: This payment is adjusted based on the diagnosis. 310 - Transesophageal Doppler Used for Cardiac Monitoring (Rev. 2743, Issued: 07- 25-13, Effective: 07 -01-01-13, Implementation, 08- 26-13) Effective May 17, 2007, Transesophageal Doppler used for cardiac monitoring is covered for ventilated patients in the ICU and operative patients with a need for intra -operative fluid optimization was deemed reasonable and necessary. See National Coverage Determinations Manual (Pub. 100- 03) 220.5, for complete coverage guidelines. A new Healthcare Common Procedure Coding System (HCPCS) code, G9157, Transesophageal Doppler used for cardiac monitoring, will be made effective for use for dates of service on or after January 1, 2013. 310.1 - Coding Requirements for T ransesophageal Doppler Cardiac Monitoring Furnished Before January 1, 2013 (Rev. 2743, Issued: 07- 25-13, Effective: 07 -01-01-13, Implementation, 08- 26-13) Prior to January 1, 2013, the applicable HCPCS code for Transesophageal Doppler cardiac monitoring is: HCPCS 76999 (billed with modifier - 26) when performed in a hospital setting for ventilated patients in the ICU or for operative patients with a need for intra -operative fluid optimization. If globally billed using code 76999, it shall be returned as unprocessable to the provider using a claim adjustment reason code (CARC) such as: CARC 58: Treatment was deemed by the payer to have been rendered in an inappropriate or invalid place of service. Note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. HCPCS 76999 (billed with modifier - TC) shall be denied when performed in a hospital setting for ventilated patients in the ICU or for operative patients with a need for intra -operative fluid optimization with a message such as: CARC 58: Treatment was deemed by the payer to have been rendered in an inappropriate or invalid place of service. Note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. RARC M77: Missing/incomplete/invalid place of service. MSN 17.9: Medicare (Part A/Part B) pays for this service. The provider must bill the correct Medicare contractor. (English version) or Este servicio es pagado por Medicare (Parte A/Parte B). El proveedor debe enviar la facture al contratista de Medicare correcto.(Spanish version). HCPCS 76999 (billed globally or with - 26 or - TC) when performed in an ASC setting for operative patients with a need for intra -operative fluid optimization, ultrasound diagnostic procedures are covered when performed by an entity other than the ASC. 310.2 - Coding Requirements for T ransesophageal Doppler Cardiac Monitoring Furnished On or After January 1, 2013 (Rev. 2743, Issued: 07- 25-13, Effective: 07 -01-01-13, Implementation, 08- 26-13) After January 1, 2013, the applicable HCPCS code for Transesophageal Doppler cardiac monitoring is: HCPCS G9157 : Transesophageal Doppler used for cardiac monitoring Contractors shall allow HCPCS G9157 to be billed when services are provided in POS 21 for ventilated patients in the ICU or for operative patients with a need for intra -operative fluid optimization. Contractors shall deny HCPCS 76999 when billed for Esophageal Doppler for ventilated patients in the ICU or for operative patients with a need for intra -operative fluid optimization using the following messages: CARC 189: Not otherwise classified or unlisted procedure code (CPT/HCPCS) was billed when there is a specific procedure code for this procedure/service. RARC M20: Missing/incomplete/invalid HCPCS. MSN 16.13: The code(s) your provider used is/are not valid for the date of service billed. (English version) or El/los cdigo(s) que us su proveedor no es/son vlido(s) en la fecha de servicio facturada. (Spanish version). Group Code: Contractual Obligation (CO) 310.3 - Correct Place of Service (POS) Code for T ransesophageal Doppler Cardiac Monitoring Services on Professional Claims (Rev. 2743, Issued: 07- 25-13, Effective: 07 -01-01-13, Implementation, 08- 26-13) Contractors shall pay for T ransesophageal Doppler cardiac monitoring , G9157, only when services are provided at POS 21. Contractors shall deny HCPCS G9157 when billed globally in any POS other than 21 for ventilated patients in the ICU or for operative patients with a need for intra -operative fluid optimization using the following messages: CARC 58: Treatment was deemed by the payer to have been rendered in an inappropriate or invalid place of service. Note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. MSN 16.2: This service cannot be paid when provided in this location/facility. Group Code: CO 320 - Artificial Hearts and Related Devices (Rev.10837; Issued: 06- 11-21; Effective: 12 -01-20; Implementation: 07 -27-21) Effective for claims with dates of service on or after December 1, 2020, as a result of a reconsideration of National Coverage Determination (NCD) 20.9 of the Medicare NCD Manual, coverage determinations for artificial hearts and related devices shall be m ade by the Medicare Administrative Contractors. 320.1 Coding Requirements for Artificial Hearts Furnished Before May 1, 2008 (Rev. 3054, Issued: 08- 29-14, Effective: 10 -30- 13, Implementation: 09 -30-14) Effective for discharges before May 1, 2008, Medicare does not cover the use of artificial hearts, either as a permanent replacement for a human heart or as a temporary life-support system until a human heart becomes available for transplant (often referred to a "bridge to transplant"). 320.2 Coding Requirements for Artificial Hearts Furnished On or After May 1, 2008 (Rev. 3054, Issued: 08- 29-14, Effective: 10-30- 13, Implementation: 09-30-14) Effective for discharges on or after May 1, 2008, the use of artificial hearts will be covered by Medicare under Coverage with Evidence Development (CED) when beneficiaries are enrolled in a clinical study that meets all of the criteria listed in IOM Pub. 100- 03, Medicare NCD Manual, section 20.9. 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For claims with dates of service on or after May 1, 2008, artificial hearts in the context of an approved clinical study for a Category A IDE, refer to section 69 in this manual for more detail on CED billing. Appropriate ICD-10 diagnosis and procedure cod es are included below: ICD-10 Diagnosis Code Definition Discharges Effective I09.81 Rheumatic heart failure On or After ICD-10 Implementation I11.0 Hypertensive heart disease with heart failure I13.0 Hypertensive heart and chronic kidney disease with heart failure and stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease I13.2 Hypertensive heart and chronic kidney disease with heart failure and with stage 5 chronic kidney disease, or end stage renal disease I20.0 Unstable angina I21.01 ST elevation (STEMI) myocardial infarction involving left main coronary artery I21.02 ST elevation (STEMI) myocardial infarction involving left anterior descending coronary artery I21.09 ST elevation (STEMI) myocardial infarction involving other coronary artery of anterior wall I21.11 ST elevation (STEMI) myocardial infarction involving right coronary artery I21.19 ST elevation (STEMI) myocardial infarction involving other coronary artery of inferior wall I21.21 ST elevation (STEMI) myocardial infarction involving left circumflex coronary artery I21.29 ST elevation (STEMI) myocardial infarction involving other sites I21.3 ST elevation (STEMI) myocardial infarction of unspecified site I21.4 Non-ST elevation (NSTEMI) myocardial infarction I22.0 Subsequent ST elevation (STEMI) myocardial infarction of anterior wall I22.1 Subsequent ST elevation (STEMI) myocardial infarction of inferior wall I22.2 Subsequent non -ST elevation (NSTEMI) myocardial infarction I22.8 Subsequent ST elevation (STEMI) myocardial infarction of other sites I22.9 Subsequent ST elevation (STEMI) myocardial infarction of unspecified site I24.0 Acute coronary thrombosis not resulting in myocardial infarction I24.1 Dressler's syndrome I24.8 Other forms of acute ischemic heart disease I24.9 Acute ischemic heart disease, unspecified I25.10 Atherosclerotic heart disease of native coronary artery without angina pectoris I25.110 Atherosclerotic heart disease of native coronary artery with unstable angina pectoris I25.111 Atherosclerotic heart disease of native coronary artery with angina pectoris with documented spasm I25.118 Atherosclerotic heart disease of native coronary artery with other forms of angina pectoris I25.119 Atherosclerotic heart disease of native coronary artery with unspecified angina pectoris I25.5 Ischemic cardiomyopathy I25.6 Silent myocardial ischemia I25.700 Atherosclerosis of coronary artery bypass graft(s), unspecified, with unstable angina pectoris I25.701 Atherosclerosis of coronary artery bypass graft(s), unspecified, with angina pectoris with documented spasm I25.708 Atherosclerosis of coronary artery bypass graft(s), unspecified, with other forms of angina pectoris I25.709 Atherosclerosis of coronary artery bypass graft(s), unspecified, with unspecified angina pectoris I25.710 Atherosclerosis of autologous vein coronary artery bypass graft(s) with unstable angina pectoris I25.711 Atherosclerosis of autologous vein coronary artery bypass graft(s) with angina pectoris with documented spasm I25.718 Atherosclerosis of autologous vein coronary artery bypass graft(s) with other forms of angina pectoris I25.719 Atherosclerosis of autologous vein coronary artery bypass graft(s) with unspecified angina pectoris I25.720 Atherosclerosis of autologous artery coronary artery bypass graft(s) with unstable angina pectoris I25.721 Atherosclerosis of autologous artery coronary artery bypass graft(s) with angina pectoris with documented spasm I25.728 Atherosclerosis of autologous artery coronary artery bypass graft(s) with other forms of angina pectoris I25.729 Atherosclerosis of autologous artery coronary artery bypass graft(s) with unspecified angina pectoris I25.730 Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with unstable angina pectoris I25.731 Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with angina pectoris with documented spasm I25.738 Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with other forms of angina pectoris I25.739 Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with unspecified angina pectoris I25.750 Atherosclerosis of native coronary artery of transplanted heart with unstable angina I25.751 Atherosclerosis of native coronary artery of transplanted heart with angina pectoris with documented spasm I25.758 Atherosclerosis of native coronary artery of transplanted heart with other forms of angina pectoris I25.759 Atherosclerosis of native coronary artery of transplanted heart with unspecified angina pectoris I25.760 Atherosclerosis of bypass graft of coronary artery of transplanted heart with unstable angina I25.761 Atherosclerosis of bypass graft of coronary artery of transplanted heart with angina pectoris with documented spasm I25.768 Atherosclerosis of bypass graft of coronary artery of transplanted heart with other forms of angina pectoris I25.769 Atherosclerosis of bypass graft of coronary artery of transplanted heart with unspecified angina pectoris I25.790 Atherosclerosis of other coronary artery bypass graft(s) with unstable angina pectoris I25.791 Atherosclerosis of other coronary artery bypass graft(s) with angina pectoris with documented spasm I25.798 Atherosclerosis of other coronary artery bypass graft(s) with other forms of angina pectoris I25.799 Atherosclerosis of other coronary artery bypass graft(s) with unspecified angina pectoris I25.810 Atherosclerosis of coronary artery bypass graft(s) without angina pectoris I25.811 Atherosclerosis of native coronary artery of transplanted heart without angina pectoris I25.812 Atherosclerosis of bypass graft of coronary artery of transplanted heart without angina pectoris I25.89 Other forms of chronic ischemic heart disease I25.9 Chronic ischemic heart disease, unspecified I34.0 Nonrheumatic mitral (valve) insufficiency I34.1 Nonrheumatic mitral (valve) prolapse I34.2 Nonrheumatic mitral (valve) stenosis I34.8 Other nonrheumatic mitral valve disorders I34.9 Nonrheumatic mitral valve disorder, unspecified I35.0 Nonrheumatic aortic (valve) stenosis I35.1 Nonrheumatic aortic (valve) insufficiency I35.2 Nonrheumatic aortic (valve) stenosis with insufficiency I35.8 Other nonrheumatic aortic valve disorders I35.9 Nonrheumatic aortic valve disorder, unspecified I36.0 Nonrheumatic tricuspid (valve) stenosis I36.1 Nonrheumatic tricuspid (valve) insufficiency I36.2 Nonrheumatic tricuspid (valve) stenosis with insufficiency I36.8 Other nonrheumatic tricuspid valve disorders I36.9 Nonrheumatic tricuspid valve disorder, unspecified I37.0 Nonrheumatic pulmonary valve stenosis I37.1 Nonrheumatic pulmonary valve insufficiency I37.2 Nonrheumatic pulmonary valve stenosis with insufficiency I37.8 Other nonrheumatic pulmonary valve disorders I37.9 Nonrheumatic pulmonary valve disorder, unspecified I38 Endocarditis, valve unspecified I39 Endocarditis and heart valve disorders in diseases classified elsewhere I42.0 Dilated cardiomyopathy I42.2 Other hypertrophic cardiomyopathy I42.3 Endomyocardial (eosinophilic) disease I42.4 Endocardial fibroelastosis I42.5 Other restrictive cardiomyopathy I42.6 Alcoholic cardiomyopathy I42.7 Cardiomyopathy due to drug and external agent I42.8 Other cardiomyopathies I42.9 Cardiomyopathy, unspecified I43 Cardiomyopathy in diseases classified elsewhere I46.2 Cardiac arrest due to underlying cardiac condition I46.8 Cardiac arrest due to other underlying condition I46.9 Cardiac arrest, cause unspecified I47.0 Re-entry ventricular arrhythmia I47.1 Supraventricular tachycardia I47.2 Ventricular tachycardia I47.9 Paroxysmal tachycardia, unspecified I48.0 Atrial fibrillation I48.1 Atrial flutter I49.01 Ventricular fibrillation I49.02 Ventricular flutter I49.1 Atrial premature depolarization I49.2 Junctional premature depolarization I49.3 Ventricular premature depolarization I49.40 Unspecified premature depolarization I49.49 Other premature depolarization I49.5 Sick sinus syndrome I49.8 Other specified cardiac arrhythmias I49.9 Cardiac arrhythmia, unspecified I50.1 Left ventricular failure I50.20 Unspecified systolic (congestive) heart failure I50.21 Acute systolic (congestive) heart failure I50.22 Chronic systolic (congestive) heart failure I50.23 Acute on chronic systolic (congestive) heart failure I50.30 Unspecified diastolic (congestive) heart failure I50.31 Acute diastolic (congestive) heart failure I50.32 Chronic diastolic (congestive) heart failure I50.33 Acute on chronic diastolic (congestive) heart failure I50.40 Unspecified combined systolic (congestive) and diastolic (congestive) heart failure I50.41 Acute combined systolic (congestive) and diastolic (congestive) heart failure I50.42 Chronic combined systolic (congestive) and diastolic (congestive) heart failure I50.43 Acute on chronic combined systolic (congestive) and diastolic (congestive) heart failure I50.9 Heart failure, unspecified I51.4 Myocarditis, unspecified I51.9 Heart disease, unspecified I52 Other heart disorders in diseases classified elsewhere I97.0 Postcardiotomy syndrome I97.110 Postprocedural cardiac insufficiency following cardiac surgery I97.111 Postprocedural cardiac insufficiency following other surgery I97.120 Postprocedural cardiac arrest following cardiac surgery I97.121 Postprocedural cardiac arrest following other surgery I97.130 Postprocedural heart failure following cardiac surgery I97.131 Postprocedural heart failure following other surgery I97.190 Other postprocedural cardiac functional disturbances following cardiac surgery I97.191 Other postprocedural cardiac functional disturbances following other surgery I97.710 Intraoperative cardiac arrest during cardiac surgery I97.711 Intraoperative cardiac arrest during other surgery

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and diastolic (congestive) heart failure I50.42 Chronic combined systolic (congestive) and diastolic (congestive) heart failure I50.43 Acute on chronic combined systolic (congestive) and diastolic (congestive) heart failure I50.9 Heart failure, unspecified I51.4 Myocarditis, unspecified I51.9 Heart disease, unspecified I52 Other heart disorders in diseases classified elsewhere I97.0 Postcardiotomy syndrome I97.110 Postprocedural cardiac insufficiency following cardiac surgery I97.111 Postprocedural cardiac insufficiency following other surgery I97.120 Postprocedural cardiac arrest following cardiac surgery I97.121 Postprocedural cardiac arrest following other surgery I97.130 Postprocedural heart failure following cardiac surgery I97.131 Postprocedural heart failure following other surgery I97.190 Other postprocedural cardiac functional disturbances following cardiac surgery I97.191 Other postprocedural cardiac functional disturbances following other surgery I97.710 Intraoperative cardiac arrest during cardiac surgery I97.711 Intraoperative cardiac arrest during other surgery I97.790 Other intraoperative cardiac functional disturbances during cardiac surgery I97.791 Other intraoperative cardiac functional disturbances during other surgery I97.88 Other intraoperative complications of the circulatory system, not elsewhere classified I97.89 Other postprocedural complications and disorders of the circulatory system, not elsewhere classified M32.11 Endocarditis in systemic lupus erythematosus O90.89 Other complications of the puerperium, not elsewhere classified Q20.0 Common arterial trunk Q20.1 Double outlet right ventricle Q20.2 Double outlet left ventricle Q20.3 Discordant ventriculoarterial connection Q20.4 Double inlet ventricle Q20.5 Discordant atrioventricular connection Q20.6 Isomerism of atrial appendages Q20.8 Other congenital malformations of cardiac chambers and connections Q20.9 Congenital malformation of cardiac chambers and connections, unspecified Q21.0 Ventricular septal defect Q21.1 Atrial septal defect Q21.2 Atrioventricular septal defect Q21.3 Tetralogy of Fallot Q21.4 Aortopulmonary septal defect Q21.8 Other congenital malformations of cardiac septa Q21.9 Congenital malformation of cardiac septum, unspecified Q22.0 Pulmonary valve atresia Q22.1 Congenital pulmonary valve stenosis Q22.2 Congenital pulmonary valve insufficiency Q22.3 Other congenital malformations of pulmonary valve Q22.4 Congenital tricuspid stenosis Q22.5 Ebstein's anomaly Q22.6 Hypoplastic right heart syndrome Q22.8 Other congenital malformations of tricuspid valve Q22.9 Congenital malformation of tricuspid valve, unspecified Q23.0 Congenital stenosis of aortic valve Q23.1 Congenital insufficiency of aortic valve Q23.2 Congenital mitral stenosis Q23.3 Congenital mitral insufficiency Q23.4 Hypoplastic left heart syndrome Q23.8 Other congenital malformations of aortic and mitral valves Q23.9 Congenital malformation of aortic and mitral valves, unspecified Q24.0 Dextrocardia Q24.1 Levocardia Q24.2 Cor triatriatum Q24.3 Pulmonary infundibular stenosis Q24.4 Congenital subaortic stenosis Q24.5 Malformation of coronary vessels Q24.6 Congenital heart block Q24.8 Other specified congenital malformations of heart Q24.9 Congenital malformation of heart, unspecified R00.1 Bradycardia, unspecified R57.0 Cardiogenic shock T82.221A Breakdown (mechanical) of biological heart valve graft, initial encounter T82.222A Displacement of biological heart valve graft, initial encounter T82.223A Leakage of biological heart valve graft, initial encounter T82.228A Other mechanical complication of biological heart valve graft, initial encounter T82.512A Breakdown (mechanical) of artificial heart, initial encounter T82.514A Breakdown (mechanical) of infusion catheter, initial encounter T82.518A Breakdown (mechanical) of other cardiac and vascular devices and implants, initial encounter T82.519A Breakdown (mechanical) of unspecified cardiac and vascular devices and implants, initial encounter T82.522A Displacement of artificial heart, initial encounter T82.524A Displacement of infusion catheter, initial encounter T82.528A Displacement of other cardiac and vascular devices and implants, initial encounter T82.529A Displacement of unspecified cardiac and vascular devices and implants, initial encounter T82.532A Leakage of artificial heart, initial encounter T82.534A Leakage of infusion catheter, initial encounter T82.538A Leakage of other cardiac and vascular devices and implants, initial encounter T82.539A Leakage of unspecified cardiac and vascular devices and implants, initial encounter T82.592A Other mechanical complication of artificial heart, initial encounter T82.594A Other mechanical complication of infusion catheter, initial encounter T82.598A Other mechanical complication of other cardiac and vascular devices and implants, initial encounter T82.599A Other mechanical complication of unspecified cardiac and vascular devices and implants, initial encounter T86.20 Unspecified complication of heart transplant T86.21 Heart transplant rejection T86.22 Heart transplant failure T86.23 Heart transplant infection T86.290 Cardiac allograft vasculopathy T86.298 Other complications of heart transplant T86.30 Unspecified complication of heart -lung transplant T86.31 Heart -lung transplant rejection T86.32 Heart -lung transplant failure T86.33 Heart -lung transplant infection T86.39 Other complications of heart -lung transplant Z48.21 Encounter for aftercare following heart transplant Z48.280 Encounter for aftercare following heart -lung transplant Z94.1 Heart transplant status Z94.3 Heart and lungs transplant status Z95.9 Presence of cardiac and vascular implant and graft, unspecified Q24.0 Dextrocardia Q24.1 Levocardia Q24.2 Cor triatriatum Q24.3 Pulmonary infundibular stenosis Q24.4 Congenital subaortic stenosis Q24.5 Malformation of coronary vessels Q24.6 Congenital heart block Q24.8 Other specified congenital malformations of heart Q24.9 Congenital malformation of heart, unspecified R00.1 Bradycardia, unspecified R57.0 Cardiogenic shock T82.221A Breakdown (mechanical) of biological heart valve graft, initial encounter T82.222A Displacement of biological heart valve graft, initial encounter T82.223A Leakage of biological heart valve graft, initial encounter T82.228A Other mechanical complication of biological heart valve graft, initial encounter T82.512A Breakdown (mechanical) of artificial heart, initial encounter T82.514A Breakdown (mechanical) of infusion catheter, initial encounter T82.518A Breakdown (mechanical) of other cardiac and vascular devices and implants, initial encounter T82.519A Breakdown (mechanical) of unspecified cardiac and vascular devices and implants, initial encounter T82.522A Displacement of artificial heart, initial encounter T82.524A Displacement of infusion catheter, initial encounter T82.528A Displacement of other cardiac and vascular devices and implants, initial encounter T82.529A Displacement of unspecified cardiac and vascular devices and implants, initial encounter T82.532A Leakage of artificial heart, initial encounter T82.534A Leakage of infusion catheter, initial encounter T82.538A Leakage of other cardiac and vascular devices and implants, initial encounter T82.539A Leakage of unspecified cardiac and vascular devices and implants, initial encounter T82.592A Other mechanical complication of artificial heart, initial encounter T82.594A Other mechanical complication of infusion catheter, initial encounter T82.598A Other mechanical complication of other cardiac and vascular devices and implants, initial encounter T82.599A Other mechanical complication of unspecified cardiac and vascular devices and implants, initial encounter T86.20 Unspecified complication of heart transplant T86.21 Heart transplant rejection T86.22 Heart transplant failure T86.23 Heart transplant infection T86.290 Cardiac allograft vasculopathy T86.298 Other complications of heart transplant T86.30 Unspecified complication of heart -lung transplant T86.31 Heart -lung transplant rejection T86.32 Heart -lung transplant failure T86.33 Heart -lung transplant infection T86.39 Other complications of heart -lung transplant Z48.21 Encounter for aftercare following heart transplant Z48.280 Encounter for aftercare following heart -lung transplant Z94.1 Heart transplant status Z94.3 Heart and lungs transplant status Z95.9 Presence of cardiac and vascular implant and graft, unspecified

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ICD-10 Procedure Code Definition Discharges Effective 02RK0JZ Replacement of Right Ventricle with Synthetic Substitute, Open Approach On or After ICD-10 Implementation 02RL0JZ Replacement of Left Ventricle with Synthetic Substitute, Open Approach 02WA0JZ Revision of Synthetic Substitute in Heart, Open Approach NOTE: Total artificial heart is reported with a cluster of 2 codes for open replacement with synthetic substitute of the right and left ventricles- 02RK0JZ + 02RL0JZ 320.3 Ventricular Assist Devices (VADs) (Rev.10837; Issued: 06-11- 21; Effective: 12 -01-20; Implementation: 07-27-21) Medicare may cover a Ventricular Assist Device (VAD). A VAD is surgically attached to one or both intact ventricles and is used to assist or augment the ability of a damaged or weakened native heart to pump blood. Improvement in the performance of the nati ve heart may allow the device to be removed. Refer to the Internet Only Manual Publication 100-03, National Coverage Determination (NCD) Manual, section 20.9.1, for coverage criteria. 320.3.1 Post-cardiotomy (Rev.10837; Issued: 06-11- 21; Effective: 12 -01-20; Implementation: 07-27-21) Post-cardiotomy is the period following open-heart surgery. VADs used for support of blood circulation post-cardiotomy are covered only if they have received approval from the Food and Drug Administration (FDA) for that purpose, and the VADs are used according to the FDA -approved labeling instructions. 320.3.2 VADs for Short -term or Long -term Mechanical Circulatory Support (Rev.10837; Issued: 06-11- 21; Effective: 12 -01-20; Implementation: 07-27-21) Effective for claims with dates of service on or after December 1, 2020, Left ventricular assist devices (LVADs) are covered if they are FDA -approved for short-term (e.g., bridge- to-recovery and bridge- to-transplant) or long-term (e.g., destination therapy) mechanical circulatory support for heart failure patients who meet spec ific clinical criteria outlined in NCD 20.9.1. 320.3.3 Other (Rev. 12396; Issued: 12-07- 23; Effective: 01 -09-24; Implementation: 01-09-24) All other indications for the use of VADs not otherwise listed remain non-covered, except in the context of Category B investigational device exemption clinical trials (42 CFR 405) or as a routine cost in clinical trials defined under section 310.1 of the NCD Manual. Claims Coding Appropriate ICD -10 diagnosis and procedure codes are included below: ICD-10 Diagnosis Code Definition I09.81 Rheumatic heart failure I11.0 Hypertensive heart disease with heart failure I13.0 Hypertensive heart and chronic kidney disease with heart failure and stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease I13.2 Hypertensive heart and chronic kidney disease with heart failure and with stage 5 chronic kidney disease, or end stage renal disease I20.0 Unstable angina I21.01 ST elevation (STEMI) myocardial infarction involving left main coronary artery ST elevation (STEMI) myocardial infarction involving left I21.02 anterior descending coronary artery I21.09 ST elevation (STEMI) myocardial infarction involving other coronary artery of anterior wall I21.11 ST elevation (STEMI) myocardial infarction involving right coronary artery I21.19 ST elevation (STEMI) myocardial infarction involving other coronary artery of inferior wall I21.21 ST elevation (STEMI) myocardial infarction involving left circumflex coronary artery I21.29 ST elevation (STEMI) myocardial infarction involving other sites I21.3 ST elevation (STEMI) myocardial infarction of unspecified site I21.4 Non-ST elevation (NSTEMI) myocardial infarction I22.0 Subsequent ST elevation (STEMI) myocardial infarction of anterior wall I22.1 Subsequent ST elevation (STEMI) myocardial infarction of inferior wall I22.2 Subsequent non -ST elevation (NSTEMI) myocardial infarction I22.8 Subsequent ST elevation (STEMI) myocardial infarction of other sites I22.9 Subsequent ST elevation (STEMI) myocardial infarction of unspecified site I24.0 Acute coronary thrombosis not resulting in myocardial infarction I24.1 Dressler's syndrome I24.81 Acute coronary microvascular dysfunction Effective 10/1/23 I24.89 Other forms of acute ischemic heart disease Effective 10/1/23 I24.9 Acute ischemic heart disease, unspecified I25.10 Atherosclerotic heart disease of native coronary artery without angina pectoris Atherosclerotic heart disease of native coronary artery I25.110 with unstable angina pectoris I25.111 Atherosclerotic heart disease of native coronary artery with angina pectoris with documented spasm I25.112 Atherosclerotic heart disease of native coronary artery with refractory angina pectoris I25.118 Atherosclerotic heart disease of native coronary artery with other forms of angina pectoris I25.119 Atherosclerotic heart disease of native coronary artery with unspecified angina pectoris I25.5 Ischemic cardiomyopathy I25.6 Silent myocardial ischemia I25.700 Atherosclerosis of coronary artery bypass graft(s), unspecified, with unstable angina pectoris I25.701 Atherosclerosis of coronary artery bypass graft(s), unspecified, with angina pectoris with documented spasm I25.708 Atherosclerosis of coronary artery bypass graft(s), unspecified, with other forms of angina pectoris I25.709 Atherosclerosis of coronary artery bypass graft(s), unspecified, with unspecified angina pectoris I25.710 Atherosclerosis of autologous vein coronary artery bypass graft(s) with unstable angina pectoris I25.711 Atherosclerosis of autologous vein coronary artery bypass graft(s) with angina pectoris with documented spasm I25.718 Atherosclerosis of autologous vein coronary artery bypass graft(s) with other forms of angina pectoris I25.719 Atherosclerosis of autologous vein coronary artery bypass graft(s) with unspecified angina pectoris I25.720 Atherosclerosis of autologous artery coronary artery bypass graft(s) with unstable angina pectoris I25.721 Atherosclerosis of autologous artery coronary artery bypass graft(s) with angina pectoris with documented spasm I25.728 Atherosclerosis of autologous artery coronary artery bypass graft(s) with other forms of angina pectoris I25.729 Atherosclerosis of autologous artery coronary artery bypass graft(s) with unspecified angina pectoris I25.730 Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with unstable angina pectoris I25.731 Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with angina pectoris with documented spasm I25.738 Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with other forms of angina pectoris I25.739 Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with unspecified angina pectoris I25.750 Atherosclerosis of native coronary artery of transplanted heart with unstable angina I25.751 Atherosclerosis of native coronary artery of transplanted heart with angina pectoris with documented spasm I25.758 Atherosclerosis of native coronary artery of transplanted heart with other forms of angina pectoris I25.759 Atherosclerosis of native coronary artery of transplanted heart with unspecified angina pectoris I25.760 Atherosclerosis of bypass graft of coronary artery of transplanted heart with unstable angina I25.761 Atherosclerosis of bypass graft of coronary artery of transplanted heart with angina pectoris with documented spasm I25.768 Atherosclerosis of bypass graft of coronary artery of transplanted heart with other forms of angina pectoris I25.769 Atherosclerosis of bypass graft of coronary artery of transplanted heart with unspecified angina pectoris I25.790 Atherosclerosis of other coronary artery bypass graft(s) with unstable angina pectoris I25.791 Atherosclerosis of other coronary artery bypass graft(s) with angina pectoris with documented spasm Atherosclerosis of other coronary artery bypass graft(s) I25.798 with other forms of angina pectoris I25.799 Atherosclerosis of other coronary artery bypass graft(s) with unspecified angina pectoris I25.810 Atherosclerosis of coronary artery bypass graft(s) without angina pectoris I25.811 Atherosclerosis of native coronary artery of transplanted heart without angina pectoris I25.812 Atherosclerosis of bypass graft of coronary artery of transplanted heart without angina pectoris I25.89 Other forms of chronic ischemic heart disease I25.9 Chronic ischemic heart disease, unspecified I34.0 Nonrheumatic mitral (valve) insufficiency I34.1 Nonrheumatic mitral (valve) prolapse I34.2 Nonrheumatic mitral (valve) stenosis I34.8 Other nonrheumatic mitral valve disorders I34.9 Nonrheumatic mitral valve disorder, unspecified I35.0 Nonrheumatic aortic (valve) stenosis I35.1 Nonrheumatic aortic (valve) insufficiency I35.2 Nonrheumatic aortic (valve) stenosis with insufficiency I35.8 Other nonrheumatic aortic valve disorders I35.9 Nonrheumatic aortic valve disorder, unspecified I36.0 Nonrheumatic tricuspid (valve) stenosis I36.1 Nonrheumatic tricuspid (valve) insufficiency I36.2 Nonrheumatic tricuspid (valve) stenosis with insufficiency I36.8 Other nonrheumatic tricuspid valve disorders I36.9 Nonrheumatic tricuspid valve disorder, unspecified I37.0 Nonrheumatic pulmonary valve stenosis I37.1 Nonrheumatic pulmonary valve insufficiency I37.2 Nonrheumatic pulmonary valve stenosis with insufficiency I37.8 Other nonrheumatic pulmonary valve disorders I37.9 Nonrheumatic pulmonary valve disorder, unspecified I38 Endocarditis, valve unspecified

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I37.2 Nonrheumatic pulmonary valve stenosis with insufficiency I37.8 Other nonrheumatic pulmonary valve disorders I37.9 Nonrheumatic pulmonary valve disorder, unspecified I38 Endocarditis, valve unspecified I39 Endocarditis and heart valve disorders in diseases classified elsewhere I42.0 Dilated cardiomyopathy I42.2 Other hypertrophic cardiomyopathy I42.3 Endomyocardial (eosinophilic) disease I42.4 Endocardial fibroelastosis I42.5 Other restrictive cardiomyopathy I42.6 Alcoholic cardiomyopathy I42.7 Cardiomyopathy due to drug and external agent I42.8 Other cardiomyopathies I42.9 Cardiomyopathy, unspecified I43 Cardiomyopathy in diseases classified elsewhere I46.2 Cardiac arrest due to underlying cardiac condition I46.8 Cardiac arrest due to other underlying condition I46.9 Cardiac arrest, cause unspecified I47.0 Re-entry ventricular arrhythmia I47.2 Ventricular tachycardia I47.9 Paroxysmal tachycardia, unspecified I47.10 Supraventricular tachycardia, unspecified Effective 10/1/23 I47.11 Inappropriate sinus tachycardia, so stated Effective 10/1/23 I47.19 Other supraventricular tachycardia Effective 10/1/23 I48.0 Atrial fibrillation I48.11 Longstanding persistent atrial fibrillation I48.19 Other persistent atrial fibrillation I49.01 Ventricular fibrillation I49.02 Ventricular flutter I49.1 Atrial premature depolarization I49.2 Junctional premature depolarization I49.3 Ventricular premature depolarization I49.40 Unspecified premature depolarization I49.49 Other premature depolarization I49.5 Sick sinus syndrome I49.8 Other specified cardiac arrhythmias I49.9 Cardiac arrhythmia, unspecified I50.1 Left ventricular failure I50.20 Unspecified systolic (congestive) heart failure I50.21 Acute systolic (congestive) heart failure I50.22 Chronic systolic (congestive) heart failure I50.23 Acute on chronic systolic (congestive) heart failure I50.30 Unspecified diastolic (congestive) heart failure I50.31 Acute diastolic (congestive) heart failure I50.32 Chronic diastolic (congestive) heart failure I50.33 Acute on chronic diastolic (congestive) heart failure I50.40 Unspecified combined systolic (congestive) and diastolic (congestive) heart failure I50.41 Acute combined systolic (congestive) and diastolic (congestive) heart failure I50.42 Chronic combined systolic (congestive) and diastolic (congestive) heart failure I50.43 Acute on chronic combined systolic (congestive) and diastolic (congestive) heart failure I50.84 End-stage heart failure I50.9 Heart failure, unspecified I51.4 Myocarditis, unspecified I51.9 Heart disease, unspecified I52 Other heart disorders in diseases classified elsewhere I97.0 Postcardiotomy syndrome I97.110 Postprocedural cardiac insufficiency following cardiac surgery I97.111 Postprocedural cardiac insufficiency following other surgery I97.120 Postprocedural cardiac arrest following cardiac surgery I97.121 Postprocedural cardiac arrest following other surgery I97.130 Postprocedural heart failure following cardiac surgery I97.131 Postprocedural heart failure following other surgery I97.190 Other postprocedural cardiac functional disturbances following cardiac surgery I97.191 Other postprocedural cardiac functional disturbances following other surgery I97.710 Intraoperative cardiac arrest during cardiac surgery I97.711 Intraoperative cardiac arrest during other surgery I97.790 Other intraoperative cardiac functional disturbances during cardiac surgery I97.791 Other intraoperative cardiac functional disturbances during other surgery I97.88 Other intraoperative complications of the circulatory system, not elsewhere classified I97.89 Other postprocedural complications and disorders of the circulatory system, not elsewhere classified M32.11 Endocarditis in systemic lupus erythematosus R00.1 Bradycardia, unspecified R57.0 Cardiogenic shock T82.221A Breakdown (mechanical) of biological heart valve graft, initial encounter T82.222A Displacement of biological heart valve graft, initial encounter T82.223A Leakage of biological heart valve graft, initial encounter T82.228A Other mechanical complication of biological heart valve graft, initial encounter T82.512A Breakdown (mechanical) of artificial heart, initial encounter T82.514A Breakdown (mechanical) of infusion catheter, initial encounter T82.518A Breakdown (mechanical) of other cardiac and vascular devices and implants, initial encounter T82.522A Displacement of artificial heart, initial encounter T82.528A Displacement of other cardiac and vascular devices and implants, initial encounter T82.529A Displacement of unspecified cardiac and vascular devices and implants, initial encounter T82.532A Leakage of artificial heart, initial encounter T82.538A Leakage of other cardiac and vascular devices and implants, initial encounter T82.592A Other mechanical complication of artificial heart, initial encounter T82.598A Other mechanical complication of other cardiac and vascular devices and implants, initial encounter T86.20 Unspecified complication of heart transplant T86.21 Heart transplant rejection T86.22 Heart transplant failure T86.23 Heart transplant infection T86.290 Cardiac allograft vasculopathy T86.298 Other complications of heart transplant T86.30 Unspecified complication of heart -lung transplant T86.31 Heart -lung transplant rejection T86.32 Heart -lung transplant failure T86.33 Heart -lung transplant infection T86.39 Other complications of heart -lung transplant Z48.21 Encounter for aftercare following heart transplant Z48.280 Encounter for aftercare following heart -lung transplant Z94.1 Heart transplant status Z94.3 Heart and lungs transplant status This policy does not address coverage of VADs for right ventricular support, biventricular support, use in beneficiaries under the age of 18, use in beneficiaries with complex congenital heart disease, or use in beneficiaries with acute heart failure without a history of chronic heart failure. Coverage under section 1862(a) (1) (A) of the Social Security Act for VADs in these situations will be made by local Medicare Administrative Contractors (MACs) within their respective jurisdictions. 320.3.4 Replacement Accessories and Supplies for External VADs or Any VAD (Rev.10837; Issued: 06- 11-21; Effective: 12 -01-20; Implementation: 07 -27-21) Effective April 1, 2013, claims for replacement of accessories and supplies for VADs implanted in patients who were not eligible for coverage under Medicare Part A or had other insurance that paid for the device and hospital stay at the time that the devic e was implanted, but are now eligible for coverage of the replacement supplies and accessories under Part B, should be submitted using HCPCS code Q0509. Those claims will be manually reviewed. In rare instances it may be appropriate to pay for replacement of supplies and accessories for external VADs used by patient who are discharged from the hospital. In addition, in some rare instances, it may be necessary for a patient to have an emergency b ack-up controller for an external VAD. Coverage of these items is at the discretion of the contractor. Claims for replacement of supplies and accessories used with an external VAD that are furnished by suppliers should be billed to the Part B MACs. Claims for replacement of supplies and accessories used with an external VAD that are furnished by hospitals and other providers should be billed to the Part AMACs. Effective April 1, 2013, these items should be billed using code Q0507 so that the claims can be m anually reviewed. Claims for replacement supplies or accessories used with VADs that do not have specific HCPCS codes and do not meet the criteria of codes Q0507 and Q0509 should be billed using code Q0508. Claims Coding HCPCS Definition Effective Date Q0507 Miscellaneous Supply Or Accessory For Use With An External Ventricular Assist Device April 1, 2013 Q0508 Miscellaneous Supply or Accessory For Use With An Implanted Ventricular Assist Device April 1, 2013 Q0509 Miscellaneous Supply Or Accessory For Use With Any Implanted Ventricular Assist Device For Which Payment Was Not Made Under Medicare Part A April 1, 2013 Q0480:Driver for use with pneumatic ventricular assist device, replacement only Q0481:Microprocessor control unit for use with electric ventricular assist device, replacement only Q0482:Microprocessor control unit for use with electric/pneumatic combination ventricular assist device, replacement only Q0483:Monitor/display module for use with electric ventricular assist device, replacement only Q0484:Monitor/display module for use with electric or electric/pneumatic ventricular assist device, replacement only Q0485:Monitor control cable for use with electric ventricular assist device, replacement only Q0486:Monitor control cable for use with electric/pneumatic ventricular assist device, replacement only Q0487:Leads (pneumatic/electrical) for use with any type electric/pneumatic ventricular assist device, replacement only Q0488:Power pack base for use with electric ventricular assist device, replacement only Q0489:Power pack base for use with electric/pneumatic ventricular assist device, replacement only Q0490:Emergency power source for use with electric ventricular assist device, replacement only Q0491:Emergency power source for use with electric/pneumatic ventricular assist device, replacement only Q0492:Emergency power supply cable for use with electric ventricular assist device, replacement only Q0493:Emergency power supply cable for use with electric/pneumatic ventricular assist device, replacement only Q0494:Emergency hand pump for use with electric or electric/pneumatic ventricular assist device, replacement only Q0495:Battery/power pack charger for use with electric or electric/pneumatic ventricular assist device, replacement only Q0496:Battery, other than lithium -ion, for use with electric or electric/pneumatic ventricular assist device, replacement only Q0497:Battery clips for use with electric or electric/pneumatic ventricular assist device, replacement only Q0498:Holster for use with electric or electric/pneumatic ventricular assist device, replacement only Q0499:Belt/vest/bag for use to carry external peripheral components of any type ventricular assist device, replacement only Q0500:Filters for use with electric or electric/pneumatic ventricular assist device, replacement only Q0501:Shower cover for use with electric or electric/pneumatic ventricular assist device, replacement only Q0502:Mobility cart for pneumatic ventricular assist device, replacement only Q0503:Battery for pneumatic ventricular assist device, replacement only, each Q0504:Power adapter for pneumatic ventricular assist device, replacement only, vehicle type Q0506:Battery, lithium -ion, for use with electric or electric/pneumatic ventricular assist device, replacement only NOTE: When determined to be medically necessary, dressings used with VADs are covered under the prosthetic device benefit as a supply necessary for the effective use of the VAD/prosthetic device. Claims for dressings necessary for the effective use of a VAD should be billed using the appropriate miscellaneous VAD supply code, depending upon whether the patient was eligible for coverage under Medicare Part A at the time that the VAD was implanted. The claims processing jurisdiction for dressings used with VADs is identical to that of other VAD replacement supplies and accessories and does not fall under Durable Medical Equipment MAC jurisdiction. 330 Percutaneous Image -guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS) (Rev. 2959, Issued: 05- 16-14, Effective: 01 -09-14, Implementation: 10- 06-14)

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330 Percutaneous Image -guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS) (Rev. 2959, Issued: 05- 16-14, Effective: 01 -09-14, Implementation: 10- 06-14) PILD is a posterior decompression of the lumbar spine performed under indirect image guidance without any direct visualization of the surgical area. This is a procedure proposed as a treatment for symptomatic LSS unresponsive to conservative therapy. Thi s procedure is generally described as a non -invasive procedure using specially designed instruments to percutaneously remove a portion of the lamina and debulk the ligamentum flavum. The procedure is performed under x -ray guidance (e.g., fluoroscopic, CT) with the assistance of contrast media to identify and monitor the compressed area via epiduragram. For complete Medical coverage guidelines, see National Coverage Determinations (NCD) Manual (Pub 100- 03) 150.13. 330.1 Claims Processing Requirements for Percutaneous Image -guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS) on Professional Claims (Rev. 3811, Issued: 07- 25-17, Effective: 12 -07-16, Implementation: 06- 27-17) For claims with dates of service on or after January 9, 2014, PILD (procedure code 0275T) is a covered service when billed as part of a clinical trial approved by CMS. The description for CPT 0275T is Percutaneous laminotomy/laminectomy (intralaminar approach) for decompression of neural elements, (with or without ligamentous resection, discectomy, facetectomy and/or foraminotomy, any method, under indirect image guidance (e.g., fluoroscopic, CT), with or without the use of an endoscope, single or multiple levels, unilateral or bilateral; lumbar. For claims with dates of service on or after January 1, 2015, PILD (procedure code G0276) is a covered service when billed as part of a clinical trial approved by CMS. HCPCS G0276 is Blinded procedure for lumbar stenosis, percutaneous image- guided lumbar decompression (PILD), or placebo control, performed in an approved coverage with evidence development (CED) clinical trial. Effective for dates of service on or after December 7, 2016, Medicare will cover PILD under CED for beneficiaries with LSS who are enrolled in a CMS -approved prospective longitudinal study for PILD procedures using a FDA -approved/cleared device that comple ted a CMS -approved randomized, controlled clinical trial (RCT) that met the criteria listed in the January 2014 NCD (see CR 8757, transmittal # 2959, dated May 16, 2014). The claim may only contain one of these procedure codes, not both. To use G0276, the procedure must be performed in an approved CED clinical trial that is randomized, blinded, and contains a placebo control arm of the trial. CMS will cover procedure code 0275T for PILD only when the procedure is performed within any other CED approved clinical trial. Regardless of the type of CED approved clinical trial (e.g. G0276 vs 0275T), PILD is only covered when billed for the ICD -9 diagnosis of 724.01- 724.03 or the ICD -10 diagnosis of M48.05- M48.07, when billed in places of service 22 (Outpatient) or 24 (Ambulatory Surgical Center), when billed along with V70.7 (ICD -9) or Z00.6 (ICD -10) in either the primary/secondary positions, and when billed with modifier Q0. Additionally, per Transmittal 2805 (Change Request 8401), issued October 30, 2013, all claims for clinical trials must contain the 8 digit clinical trial identifier number. The following message(s) shall be used to notify providers of return situations that may occur: Professional Claims 8-digit Clinical Trial Number For PILD claims with procedure code 0275T with dates of service on or after January 9, 2014 , or for claims with procedure code G0276 with dates of service on or after January 1, 2015, contractors shall pay for PILD only when billed with the numeric, 8-digit clinical trial identifier number preceded by the two alpha characters CT when placed in Field 19 of paper Form CMS -1500, or when entered without the CT prefix in the electronic 837P in Loop 2300 REF02 (REF01=P4). Claims for PILD which are billed wit hout an 8-digit clinical trial identifier number shall be returned as unprocessable. The following messages shall be used when Medicare contractors return PILD claims billed without an 8 -digit clinical trial identifier number as unprocessable: Claims Adjustment Reason Code 16: Claim/service lacks information or has submission/billing error(s) which is needed for adjudication. Remittance Advice Remark Code N721: This service is only covered when performed as part of a clinical trial. Remittance Advice Remark Code MA50: Missing/incomplete/invalid Investigational Device Exemption number or Clinical Trial number . Remittance Advice Remark Code N704: "Alert: You may not appeal this decision but can resubmit this claim/service with corrected information if warranted." Professional Claims Place of Service 22 or 24 For PILD claims with procedure code 0275T with dates of service on or after January 9, 2014 , or for claims with procedure code G0276 with dates of service on or after January 1, 2015, contractors shall pay for PILD for LSS claims only when billed in place of service 22 or 24. Claims for PILD which are billed in any other place of service shall be returned a s unprocessable. The following messages shall be used when Medicare contractors return PILD claims not billed in place of service 22 or 24: Claims Adjustment Reason Code 58: Treatment was deemed by the payer to have been rendered in an inappropriate or invalid place of service. Remittance Advice Remark Code N704: "Alert: You may not appeal this decision but can resubmit this claim/service with corrected information if warranted." Professional Claims Modifier Q0 For PILD claims with procedure code 0275T with dates of service on or after January 9, 2014 , or for claims with procedure code G0276 with dates of service on or after January 1, 2015, contractors shall pay for PILD for LSS claims only when billed with modifier Q0. Claims for PILD which are billed without modifier Q0 shall be returned as unproce ssable. The following messages shall be used when Medicare contractors return PILD claims billed without modifier Q0 as unprocessable: Claims Adjustment Reason Code 4: The procedure code is inconsistent with the modifier used or a required modifier is missing. Remittance Advice Remark Code N657: This should be billed with the appropriate code for these services." Remittance Advice Remark Code N704: "Alert: You may not appeal this decision but can resubmit this claim/service with corrected information if warranted." Non-covered Diagnosis For PILD claims with procedure code 0275T with dates of service on or after January 9, 2014, or for claims with procedure code G0276 with dates of service on or after January 1, 2015, contractors shall pay for PILD for LSS claims only when billed with the ICD -9 diagnosis of 724.01- 724.03 or the ICD -10 diagnosis of M48.05- M48.07. The following messages shall be used when Medicare contractors return PILD claims, billed without the covered diagnosis, as unprocessable: Claims Adjustment Reason Code B22: This payment is adjusted based on the diagnosis. Remittance Advice Remark Code N704: "Alert: You may not appeal this decision but can resubmit this claim/service with corrected information if warranted." Clinical Trial Diagnosis For PILD claims with procedure code 0275T with dates of service on or after January 9, 2014, or for claims with procedure code G0276 with dates of service on or after January 1, 2015, contractors shall pay for PILD only when billed with the ICD -9 diagnosis of V70.7 (ICD -9) or Z00.6 (ICD -10) in either the primary or secondary positions. The following messages shall be used when Medicare contractors return PILD claims, billed without the clinical trial diagnosis, as unprocessable: Claims Adjustment Reason Code B22: This payment is adjusted based on the diagnosis. Remittance Advice Remark Code N704: "Alert: You may not appeal this decision but can resubmit this claim/service with corrected information if warranted." 330.2 - Claims Processing Requirements for PILD for Outpatient Facilities (Rev. 3811, Issued: 07- 25-17, Effective: 12 -07-16, Implementation: 06- 27-17) Hospital Outpatient facilities shall bill for percutaneous image -guided lumbar decompression (PILD) procedure code 0275T effective on or after January 9, 2014, or procedure code G0276 effective on or after January 1, 2015, for lumbar spinal stenosis (LSS) on a 13X or 85X TOB. Refer to Section 69 of this chapter for further guidance on billing under CED. Effective for dates of service on or after December 7, 2016, Medicare will cover PILD under CED for beneficiaries with LSS who are enrolled in a CMS -approved prospective longitudinal study for PILD procedures using a FDA -approved/cleared device that comple ted a CMS -approved randomized, controlled clinical trial (RCT) that met the criteria listed in the January 2014 NCD (see CR 8757, transmittal # 2959, dated May 16, 2014). Hospital outpatient procedures for PILD shall be covered when billed with: ICD-9 V70.7 (ICD -10 Z00.6) and Condition Code 30. Modifier Q0 An 8 -digit clinical trial identifier number listed on the CMS Coverage with Evidence Development website Hospital outpatient procedures for PILD shall be rejected when billed without: ICD-9 V70.7 (ICD -10 Z00.6) and Condition Code 30. Modifier Q0 An 8 -digit clinical trial identifier number listed on the CMS Coverage with Evidence Development website Claims billed by hospitals not participating in the trial /registry, shall be rejected with the following message: 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 http://www.cms.hhs.gov/mcd/search.asp. If you do not have web access, you may contact the contractor to request a copy of the NCD. Group Code Contractual Obligation (CO) MSN 16.77 This service/item was not covered because it was not provided as part of a qualifying trial/study. (Este servicio/artculo no fue cubierto porque no estaba incluido como parte de un ensayo clnico/estudio calificado.) 340 Transcatheter Edge -to-Edge Repair (TEER) for Mitral Valve Regurgitation (Rev. 10985; Issued:09-08-21, Effective:01-19- 21; Implementation:10 -08-21) Transcatheter Edge- to-Edge Repair (TEER) of the mitral valve (previously named Transcatheter Mitral Valve Repair (TMVR)) is used in the treatment of mitral regurgitation (MR). TEER approximates the anterior and posterior mitral valve leaflets by grasping them with a clipping device in an approach similar to a treatment developed in cardiac surgery called the Alfieri stitch.

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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 http://www.cms.hhs.gov/mcd/search.asp. If you do not have web access, you may contact the contractor to request a copy of the NCD. Group Code Contractual Obligation (CO) MSN 16.77 This service/item was not covered because it was not provided as part of a qualifying trial/study. (Este servicio/artculo no fue cubierto porque no estaba incluido como parte de un ensayo clnico/estudio calificado.) 340 Transcatheter Edge -to-Edge Repair (TEER) for Mitral Valve Regurgitation (Rev. 10985; Issued:09-08-21, Effective:01-19- 21; Implementation:10 -08-21) Transcatheter Edge- to-Edge Repair (TEER) of the mitral valve (previously named Transcatheter Mitral Valve Repair (TMVR)) is used in the treatment of mitral regurgitation (MR). TEER approximates the anterior and posterior mitral valve leaflets by grasping them with a clipping device in an approach similar to a treatment developed in cardiac surgery called the Alfieri stitch. The most recent reconsideration of NCD 20.33 (TEER for Mitral Valve Regurgitation (previously named TMVR)) is effective for claims with dates of service on and after January 19, 2021. It expands coverage of mitral valve TEER procedures for the treatment of functional MR and maintains coverage of TEER for the treatment of degenerative MR, through coverage with evidence development (CED) and with mandatory registry participation. It also makes changes to the criteria for the heart team and hospital, and to the registry questions/criteria and the trial requirements and outcomes. For more detailed information see Pub. 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Section 20.33. For services furnished between August 7, 2014 and January 19, 2021, the CMS covered TMVR for MR when furnished under CED when the treatment was furnished for an FDA-approved indication with an FDA-approved device as follows: (1) Treatment of significant, symptomatic, degenerative MR when furnished according to an FDA-approved indication and all CMS coverage criteria are met, and, (2) TMVR for MR uses not expressly listed as FDA -approved indications but only within the context of an FDA-approved, randomized clinical trial that meets all CMS coverage criteria. TMVR was non-covered outside CED or for non-MR indications. Historical Note: For claims processing instructions from August 7, 2014, through January 19, 2021, please see the following links: Change request (CR) 9002, Transmittal (TN) 178, issued December 5, 2014, informed Medicare Administrative Contractors to pay for TMVR under CED and revised the NCD manual to add NCD 20.33: https://www.cms.gov/Regulations- and-Guidance/Guidance/Transmittals/Downloads/R178NCD.pdf. CR 9002, TR 3142, issued December 5, 2014, implemented the initial NCD for TMVR, effective August 7, 2014. TR 3241 rescinded and replaced TN 3142 on April 25, 2014: https://www.cms.gov/Regulations- and-Guidance/Guidance/Transmittals/Downloads/R3241CP.pdf . ICD-10 Coding Updates: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10 340.1 Coding Requirements for Mitral Valve TEER Claims Furnished on or After August 7, 2014 (Rev. 10985; Issued:09- 08-21, Effective:01 -19-21; Implementation:10 -08-21) Current Procedural Terminology (CPT) Codes for Mitral Valve TEER Claims CPT code 33418, Transcatheter mitral valve repair, percutaneous approach, including transseptal puncture when performed; initial prosthesis, effective January 1, 2015. CPT code 33419, Transcatheter mitral valve repair, percutaneous approach, including transseptal puncture when performed; additional prosthesis (es) during same session, effective January 1, 2015. (List separately in addition to code for primary procedure). 0345T - Transcatheter mitral valve repair percutaneous approach via the coronary sinus ICD- 10 Procedure Code for Mitral Valve TEER Claims 02UG3JZ Supplement mitral valve with synthetic substitute, percutaneous approach 02UG3JH Supplemental mitral valve with synthetic substitute, transapical, percutaneous approach ICD- 10 Diagnosis Codes for Mitral Valve TEER I34.0 Nonrheumatic mitral (valve) insufficiency, or, I34.1 Nonrheumatic mitral (valve) prolapse, and, Z00.6 Encounter for examination for normal comparison and control in clinical research program 340.2 Claims Processing Requirements for Mitral Valve TEER Services on Professional Claims (Rev. 10985; Issued:09- 08-21, Effective:01 -19-21; Implementation:10 -08-21) Professional Claims Place of Service (POS) Codes for Mitral Valve TEER Claims Effective for claims with dates of service on and after August 7, 2014, place of service (POS) code 21 shall be used for mitral valve TEER services. All other POS codes shall be denied. The following messages shall be used when Medicare contractors deny mitral valve TEER claims for POS: Claim Adjustment Reason Code (CARC) 58: Treatment was deemed by the payer to have been rendered in an inappropriate or invalid place of service. Note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), i f present. Group Code: CO (Contractual Obligation) assigning financial liability to the provider (if a claim is received with a GZ modifier indicating no signed ABN is on file.) Medicare Summary Notice (MSN) 21.25: This service was denied because Medicare only covers this service in certain settings. Spanish Version: El servicio fue denegado porque Medicare solamente lo cubre en ciertas situaciones." Professional Claims Modifiers for Mitral Valve TEER Claims Effective for claims with dates of service on or after August 7, 2014, contractors shall pay claim lines for mitral valve TEERs billed with the most recent CPT codes 33418, 33419, and 0345T in a clinical trial when billed with modifier - Q0. Mitral valve TE ER claim lines in a clinical trial billed without modifier - Q0 shall be returned as unprocessable. The following messages shall be used when Medicare contractors return mitral valve TEER claim lines in a clinical trial billed without modifier - Q0 as unprocessable: CARC 4: The procedure code is inconsistent with the modifier used or a required modifier is missing. Note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. 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 w eb access, you may contact the contractor to request a copy of the NCD. Group Code: CO (Contractual Obligation) assigning financial liability to the provider (if a claim is received with a GZ modifier indicating no signed ABN is on file.) Professional Clinical Trial Diagnostic Coding for Mitral Valve TEER Claims Effective for claims with dates of service on or after August 7, 2014 contractors shall pay claim lines for mitral valve TEERs billed with the most recent CPT codes 33418, 33419 and 0345T in a clinical trial when billed with the most recent ICD -10 diagnosi s codes ICD -10 I34.0 or I34.1 and secondary ICD -10 diagnosis code Z00.6. Mitral valve TEER claim lines in a clinical trial billed without ICD -10 diagnosis code I34.0 or I34.1 and secondary ICD -10 diagnosis code Z00.6 shall be denied. The following messages shall be used when Medicare contractors deny mitral valve TEER claim lines in a clinical trial billed without secondary ICD -10 diagnosis code Z00.6: 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 http://www.cms.hhs.gov/mcd/search.asp. If you do not have web access, you may contact the contractor to request a copy of the NCD Group Code: CO (Contractual Obligation) assigning financial liability to the provider (if a claim is received with a GZ modifier indicating no signed ABN is on file.) MSN 15.20: The following policies [NCD 20.33]] were used when we made this decision Spanish Version: MSN 15.20: Las siguientes polticas [NCD 20.33] fueron utilizadas cuando se tom esta decisin. Mandatory National Clinical Trial (NCT) Number for Mitral Valve TEER Claims Effective for claims with dates of service on or after August 7, 2014, contractors shall pay mitral valve TEER claim lines billed with the most recent CPT codes 33418, 33419, and 0345T in a clinical trial only when billed with an 8- digit national clinical trial (NCT) number. Contractors shall accept the numeric, 8 -digit NCT number preceded by the two alpha characters of CT when placed in Field 19 of paper Form CMS -1500, or when entered WITHOUT the CT prefix in the electronic 837P in Loop 2300 REF02 (REF 01=P4). NOTE : The CT prefix is required on a paper claim, but it is not required on an electronic claim. Mitral valve TEER claim lines in a clinical trial billed without an 8 - digit NCT number shall be returned as unprocessable. The following messages shall be used when Medicare contractors return mitral valve TEER claim lines as unprocessable when billed without an 8- digit NCT number: CARC 16: Claim/service lacks information which is needed for adjudication. At least one Remark Code must be provided (may be comprised of either NCPDP Reject Reason Code, or Remittance Advice Remark Code that is not an ALERT.) RARC MA50: Missing/incomplete/invalid Investigational Device Exemption number for FDA -approved clinical trial services. Group Code: CO (Contractual Obligation) assigning financial liability to the provider (if a claim is received with a GZ modifier indicating no signed ABN is on file.) 340.3 - Claims Processing Requirements for Mitral Valve TEER Services on Inpatient Hospital Claims (Rev. 10985; Issued:09- 08-21, Effective:01 -19-21; Implementation:10 -08-21) Inpatient hospitals shall bill for mitral valve TEER on an 11X type of bill (TOB) effective for discharges on or after August 7, 2014. Refer to Section 69 of this chapter for further guidance on billing under CED. In addition to the ICD -10 procedure and diagnosis codes mentioned above, inpatient hospital discharges for mitral valve TEER shall be covered when billed with the following clinical trial coding: Secondary ICD -10 diagnosis code Z00.6 Condition Code 30 Value code D4 - Clinical Trial Number Assigned by NLM/NIH with an 8- digit clinicaltrials.gov identifier number listed on the CMS website Inpatient hospital discharges for mitral valve TEERs shall be denied when billed without the ICD -10 diagnosis, procedure codes and clinical trial coding mentioned above. Claims that do not include these required codes shall be rejected with the following messages: 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 http://www.cms.hhs.gov/mcd/search.asp. If you do not have web access, you may contact the contractor to request a copy of the NCD. Group Code: CO (Contractual Obligation) assigning financial liability to the provider MSN 15.20: The following policies [NCD 20.33] were used when we made this decision Spanish Version: MSN 15.20 - Las siguientes polticas [NCD 20.33] fueron utilizadas cuando se tom esta decisin.

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Inpatient hospital discharges for mitral valve TEERs shall be denied when billed without the ICD -10 diagnosis, procedure codes and clinical trial coding mentioned above. Claims that do not include these required codes shall be rejected with the following messages: 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 http://www.cms.hhs.gov/mcd/search.asp. If you do not have web access, you may contact the contractor to request a copy of the NCD. Group Code: CO (Contractual Obligation) assigning financial liability to the provider MSN 15.20: The following policies [NCD 20.33] were used when we made this decision Spanish Version: MSN 15.20 - Las siguientes polticas [NCD 20.33] fueron utilizadas cuando se tom esta decisin. 340.4 - Claims Processing Requirements for Mitral Valve TEER Services for Medicare Advantage (MA) Plan Participants (Rev. 10985; Issued:09- 08-21, Effective:01 -19-21; Implementation:10 -08-21) MA plans are responsible for payment of mitral valve TEER services for MA plan participants. Medicare coverage for mitral valve TEERs is not included under section 310.1 of the NCD Manual (Routine Costs in Clinical Trials). 350 - Emergency and Foreign Hospital Services (Rev. 3287, Issued: 06- 30-15, Effective: 04 -21-15, Implementation: 04- 21-15) The conditions for payment for services furnished in a foreign country can be found in 42 CFR 424.120- 127, Subpart H - Special Conditions: Emergency Services Furnished In a Foreign Country. The payment exclusion for services furnished outside the U.S. is located at 42 CFR 411.9 and 42 CFR 411.9(a)(2) describes the applicability of the payment exclusion when services are furnished on board a ship. 350.1 - Services Rendered By Nonparticipating Providers (Rev. 3287, Issued: 06- 30-15, Effective: 04 -21-15, Implementation: 04- 21-15) A. Services in Nonparticipating Domestic Hospital Payment may be made for certain Part A inpatient and Part B outpatient hospital services provided in a nonparticipating U.S. hospital where they are necessary to prevent the death or serious impairment of the health of the individual. Because of the threat to the life or health of the individual, the use of the most accessible hospital equipped to furnish such services is necessary. Items and services furnished in a domestic nonparticipating hospital may be reimbursed if the following apply: The hospital meets the definition of an emergency hospital. (See 350.3.) The services meet the definition of emergency services. (See 350.2.) The hospital is substantially more accessible from the site of the emergency than is the nearest participating hospital. (See 350.4.) B. Services Received by Medicare Beneficiaries outside the United States Items and services furnished outside the United States and certain services rendered on board a ship are excluded from coverage except for the following services: Emergency inpatient hospital services where the emergency occurred: o While the beneficiary was physically present in the United States; or o In Canada while the beneficiary was traveling without reasonable delay and by the most direct route between Alaska and another State. Emergency or nonemergency inpatient hospital services furnished by a hospital located outside the United States, if the hospital was closer to, or substantially more accessible from, the beneficiarys United States residence than the nearest participating United States hospital that was adequately equipped to deal with, and available to provide treatment for the illness or injury. Physician and ambulance services furnished in connection with a covered foreign hospitalization. Program payment may not be made for any other Part B medical and other health services, including outpatient services furnished outside the United States. Services rendered on board a ship in a United States port, or within 6 hours of when the ship arrived at, or departed from, a United States port, are considered to have been furnished in United States territorial waters. Services not furnished in a United States port, or within 6 hours of when the ship arrived at, or departed from, a United States port, are considered to have been furnished outside United States territorial waters, even if the ship is of United States registry. The term United States means the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, the U.S. Virgin Islands, Guam, the Northern Mariana Islands, American Samoa and, for purposes of services rendered on a ship, includes the territorial waters adjoining the land areas of the United States. A hospital that is not physically situated in one of the above jurisdictions is considered to be outside the United States, even if it is owned or operated by the United States Government. C. Ship Physicians Office is in the United States. When the physicians office is inside of the United States, the contractor designated to process the shipboard claim is determined by the beneficiarys residence. D. Ship Physicians Office is Outside of the United States. When the physicians office is outside of the United States, the contractor designated to process the shipboard claim is determined by the beneficiarys residence. MSN message 16.240 (English) Services provided aboard a ship are covered only when the ship is in United States waters. In addition, the service must be provided by a doctor licensed to practice in the United States. MSN message 16.240 (Spanish) Servicios proporcionados abordo de un barco son cubiertos solamente cuando el barco est en aguas territoriales de los Estados Unidos. Adems, el servicio debe ser proporcionado por un mdico con licencia para practicar en los Estados Unidos. Payment may not be made for any item provided or delivered to the beneficiary outside the United States, even though the beneficiary may have contracted to purchase the item while he or she was within the United States or purchased the item from an America n firm. Under the Railroad Retirement Act, payment is made to qualified Railroad Retirement beneficiaries (QRRBs) by the RRB for covered hospital services furnished in Canadian hospitals as well as in the U.S. Physician and ambulance services are not covered by t he Railroad Retirement Act; however, under an agreement between CMS and RRB, if the QRRB claims payment for Part B services in connection with Canadian hospitalization, RRB processes the Part B claim. In such cases the RRB determines: Whether the requirements are met for the inpatient services; and Whether the physician and/or ambulance services were furnished in connection with the services. Services for an individual who has elected religious nonmedical health care status may be covered if the above requirements are met but this revokes the religious nonmedical health care institution election. 350.2 - Establishing an Emergency (Rev. 3287, Issued: 06- 30-15, Effective: 04 -21-15, Implementation: 04- 21-15) Claims for emergency services must be accompanied by a physician's statement describing the nature of the emergency and stating that the services were necessary to prevent the death, or the serious impairment of, the beneficiary. A statement that an emergency existed is not sufficient. In addition, when inpatient services are involved, the statement must include the date when, in the physicians' judgment, the emergency ceased. The finding of whether the patient's condition required emergency diagnosis or treatment is ordinarily based upon the physician's evaluation of the patient's condition immediately upon the beneficiary's arrival at the hospital. However, the emergency nature of the situation may have been assessed by a physician who attended the patient where the incident resulting in hospitalization occurred (for example, a heart attack or an automobile accident). In these cases, the attending physician who ordered the hospitalization may substantiate the claim that emergency hospitalization was necessary. Most emergencies are of relatively short duration so that only one bill is submitted. Generally, only one physician's statement is necessary. However, in the rare situation where an emergency continued over an extended period, subsequent requests for payment must be accompanied by a physician's statement containing sufficient information to indicate clearly that the emergency situation still existed. A statement that the emergency continued to exist is not acceptable. Additional information to support a finding that the services were emergency services from the physician, the hospital, and others (e.g., the police department at the scene of an accident) may be requested. Medical necessity can be documented by the physician on a CMS-l77l, Attending Physician's Statement and Documentation of Medicare Emergency or by the beneficiary's medical records. The CMS-1771 can be obtained from: Centers for Medicare & Medicaid Services Forms Management Section 7500 Security Blvd. Baltimore, MD 21244-1850 Or, the form can be downloaded from http://cms.hhs.gov/Medicare/CMS- Forms/CMS -Forms/CMS -Forms -List.html 350.3 - Qualifications of an Emergency Services Hospital (Rev. 3287, Issued: 06- 30-15, Effective: 04-21-15, Implementation: 04-21-15) An emergency services hospital is a nonparticipating hospital that meets the requirements of the law's definition of a "hospital" relating to full -time nursing services and licensure under State or applicable local law. (A federal hospital need not be licensed under state or local licensing laws to meet this definition.) In addition, the hospital must be primarily engaged in providing, under the supervision of doctors of medicine or osteopathy, services of the type described in defining the term hospital. The hospital must not be primarily engaged in providing skilled nursing care and related services for patients who require medical or nursing care. Psychiatric hospitals can qualify as emergency hospitals. 350.4 - Coverage Requirements for Emergency Hospital Services Furnished Outside of the United States (Rev. 3287, Issued: 06- 30-15, Effective: 04-21-15, Implementation: 04-21-15) The following requirements must be met for payment to be made for emergency services received by Medicare beneficiaries in foreign hospitals: The hospital must meet the definition of an emergency hospital and be licensed or approved by the appropriate agency of the country in which it is located. The services meet the criteria of emergency services. The foreign hospital must be closer to or substantially more accessible from the site of the emergency than the nearest U.S. hospital that was adequately equipped and available to treat the illness or injury. 1. Emergency Occurred in the U.S. (See 350.1.B for definition of the U.S.) If the individual was physically present in the U.S. at the time the emergency occurred, the individual's reason for departure from the U.S. must have been specifically to obtain treatment at the foreign hospital. Services are not covered where the person 's departure from the U.S. is part of a trip abroad and the foreign hospital is more accessible simply because the individual was in the process of travel. For example, the airplane on which the individual was traveling could not readily return to permit the person's removal. 2. Emergency Occurred in Canada If the emergency occurred in Canada, the beneficiary must have been traveling, without unreasonable delay, by the most direct route between Alaska and another state. Benefits are not payable if the emergency occurred while a beneficiary was vacationing. The requirement of travel without unreasonable delay by the most direct route will be considered met if the emergency occurred while the beneficiary was enroute between Alaska and another state by the shortest practicable route, or while making a necessary stopover in connection with such travel. NOTE: An emergency occurring within the Canadian inland waterway between the States of Washington and Alaska is considered to have occurred in Canada. Ordinarily, the "shortest practicable route" is the one that results in the least amount of travel in Canada, consistent with the mode of travel used between the point of entry into Canada and the intended point of departure. The amount of travel in the U .S., prior to entering Canada is not pertinent. A route involving greater travel within Canada may be considered the "shortest practicable route" if the additional travel resulted in a saving of time or was necessary because of such factors as: Road or weather conditions; The age of the traveler; Health, or physical condition of the traveler; The need to make suitable travel arrangements; or The need to obtain acceptable accommodations. However, the individual would be considered to have deviated from the "shortest practicable route" if the detour was unrelated to the purpose of reaching their destination (e.g., for the principal purpose of sightseeing or vacationing). The term "necessary stopover" means a routine stopover for rest, food, or servicing of the vehicle, and a non- routine stopover (even though of significant duration) caused by such factors as unsuitable road or weather conditions, the age, health, or physical condition of the traveler, the need to make suitable travel arrangement s, or to obtain acceptable accommodations.

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Ordinarily, the "shortest practicable route" is the one that results in the least amount of travel in Canada, consistent with the mode of travel used between the point of entry into Canada and the intended point of departure. The amount of travel in the U .S., prior to entering Canada is not pertinent. A route involving greater travel within Canada may be considered the "shortest practicable route" if the additional travel resulted in a saving of time or was necessary because of such factors as: Road or weather conditions; The age of the traveler; Health, or physical condition of the traveler; The need to make suitable travel arrangements; or The need to obtain acceptable accommodations. However, the individual would be considered to have deviated from the "shortest practicable route" if the detour was unrelated to the purpose of reaching their destination (e.g., for the principal purpose of sightseeing or vacationing). The term "necessary stopover" means a routine stopover for rest, food, or servicing of the vehicle, and a non- routine stopover (even though of significant duration) caused by such factors as unsuitable road or weather conditions, the age, health, or physical condition of the traveler, the need to make suitable travel arrangement s, or to obtain acceptable accommodations. 350.5 - Services Furnished in a Foreign Hospital Nearest to Beneficiary's U.S. Residence (Rev. 3287, Issued: 06- 30-15, Effective: 04 -21-15, Implementation: 04- 21-15) Coverage is provided for inpatient hospital services furnished in a foreign hospital that is closer to, or substantially more accessible from, the beneficiary's U.S. residence than the nearest available participating U.S. hospital that is adequately equipped to deal with the illness or injury, whether or not an emergency existed and without regard to where the illness or injury occurred. "Residence" means the beneficiary's fixed and permanent home to which they intend to return whenever they are away or a dwelling where the beneficiary periodically spends some time (e.g., a summer home). The foreign hospital must meet accreditation requirements equivalent to Joint Commission standards. For example, the Canadian Council on Hospital Accreditation (CCHA) has equivalent requirements. Thus, Canadian hospitals accredited by the CCHA meet the q ualifying requirements. In the case of Mexican hospitals, the Dallas or San Francisco RO makes the determination, depending upon the hospital's location. Claims for services provided in countries other than Canada or Mexico should be sent to the MAC that is responsible for the state or territory where the emergency arose. In other words, the foreign claim would be processed similarly to how claims are processed in the state or territory where the emergency arose. See 350.11.4 below for discussion of accessibility criteria. Some claims for services furnished in a foreign hospital nearest to the beneficiary's U.S. residence will not be "emergency." In these nonemergency situations, it may be necessary to deny payment in whole or part, (even though it has been approved with re gard to accessibility) because the services are not medically reasonable and necessary or involve custodial care (i.e., exclusions under 1862(a)(1) and (9)). However, in the case of denials under the medical necessity and custodial care exclusions, the MAC applies the limitation on liability considerations under 1879 of the Act before issuing the denial notice. The MAC examines claims involving medical necessity or custodial care denials to determine if there is any evidence that the beneficiary (or the person acting on behalf of the beneficiary) was aware that the beneficiary did not require, or no longer requir ed, a covered level of care. The foreign hospital, since it is not participating, is not under any obligation to furnish a written notice of noncoverage to a beneficiary in order to protect itself from being held liable under the 1879 waiver of liability provision. However, there may be instances where the medical records of the denied foreign claim show that the beneficiary was advised that the beneficiary did not require, or no longer required, Medicare covered services, (e.g., written notice of noncoverage from the hospital's staff or a prior CMS denial notice). It will probably be rare where a finding is made that the beneficiary had knowledge of noncoverage, so that, generally, payments are made under the waiver of liability provision. The MAC uses appropriate Medicare Summary Notice (MSN) and Remittance Advice denial messages for determinations involving the limitation on liability provision. For additional information regarding the application of the 1879 liability provisions, see Pub 100- 04, chapter 30. 350.6 Coverage of Physician and Ambulance Services Furnished Outside U.S. (Rev. 3287, Issued: 06- 30-15, Effective: 04 -21-15, Implementation: 04- 21-15) Payment is made for necessary physician and ambulance services that meet the other coverage requirements of the Medicare program, and are furnished in connection with a covered foreign hospitalization. A. Coverage of Physician and Ambulance Services Furnished Outside the U.S. Where inpatient services in a foreign hospital are covered, payment may also be made for: Physicians services furnished to the beneficiary while he/she is an inpatient, Physicians services furnished to the beneficiary outside the hospital on the day of his/her admission as an inpatient, provided the services were for the same condition for which the beneficiary was hospitalized (including the services of a physician who furnishes emergency services in Canadian waters on the day the patient is admitted to a Canadian hospital for a covered emergency stay) and, Ambulance services, where necessary, for the trip to the hospital in conjunction with the beneficiarys admission as an inpatient. Return trips from a foreign hospital are not covered. In cases involving foreign ambulance services, the general requirements in chapter 15 are also applicable, subject to the following special rules: If the foreign hospitalization was determined to be covered on the basis of emergency services, the medical necessity requirements outlined in chapter 15 are considered met. The definition of physician, for purposes of coverage of services furnished outside the U.S., is expanded to include a foreign practitioner, provided the practitioner is legally licensed to practice in the country in which the services are furnished. Only the beneficiary may file for Part B benefits. The assignment method may not be used. However, where the beneficiary is deceased, the rule for settling Part B underpayments is applicable, i.e., payment may be made to the foreign physician or ambulanc e company on the basis of an unpaid bill, provided the physician or ambulance company accepts the MACs reasonable charge determination as the full charge. The regular deductible and coinsurance requirements apply to physician and ambulance services. 350.7 - Claims for Services Furnished in Canada to Qualified Railroad Retirement Beneficiaries (Rev. 3287, Issued: 06- 30-15, Effective: 04 -21-15, Implementation: 04- 21-15) All claims for hospital and/or related physician or ambulance services furnished in Canada to qualified railroad retirement beneficiaries (QRRBs) are forwarded first to the Railroad Retirement Board (RRB). Under the Railroad Retirement Act, payment is made b y the RRB to Qualified Railroad Retirement Beneficiaries (QRRB) for covered hospital services furnished in Canadian hospitals as well as in the U.S. The Railroad Retirement Act does not cover physician and ambulance services; however, under an agreement between CMS and RRB, if the QRRB claims payment for Part B services in connection with Canadian hospitalization, RRB processes the Part B claim. In such cases the RRB determines: Whether the requirements in 350.1.B and 350.6 are met in regard to the inpatient services; and Whether the requirements in 350.6.A are met in regard to the physician and/or ambulance services were furnished in connection with the services If either is not met, RRB denies the claim and notifies the beneficiary. If met, RRB refers the claim to the RRB MAC, Palmetto GBA, to determine if the coverage criteria for physician and/or ambulance services are met. The hospital must forward all claims for services furnished QRRBs in Canada to: Retirement Medicare Section U.S. Railroad Retirement Board 844 North Rush Street Chicago, IL 60611- 2092 If a QRRB is a resident of Canada, Medicare payments are reduced by the amount of payment made for the same services by the Canadian Provincial Health Insurance Plan. B. Claims for services furnished in other foreign countries The RRB does not pay for health care services furnished in Mexico or any foreign countries other than Canada. All claims for inpatient hospital services and/or related physician or ambulance services furnished in Mexico to QRRBs should be forwarded directly to the Railroad Retirement Board. If the Railroad Retirement Board determines that the requirements in 350.6.A are not met, the Railroad Retirement Board will deny the claim and send notice to the beneficiary. If the requirements in 350.6.A or B are met, the Railroad Retirement Board will hold any potentially allowable Part B claim until an MAC determination regarding the coverage of Part A services has been made. When the information regarding Part A coverage is available, the Railroad Retirement Board will send the Part B claim, together with pertinent information regarding the Part A determination, to P almetto Government Benefits for consideration of whether the other requirements for Part B coverage are met, and further processing. 350.8 - Claims from Hospital -Leased Laboratories Not Meeting Conditions of Participation (Rev. 3287, Issued: 06- 30-15, Effective: 04 -21-15, Implementation: 04- 21-15) Services furnished by a laboratory that does not meet the hospital laboratory conditions of participation and is operated under a lease arrangement in a domestic emergency hospital are covered only if they are emergency inpatient services reimbursable under Part A. A MAC may send a claim from such a laboratory and identify it as an "Emergency Lead." The MAC checks its files to see if a claim for emergency services was filed and, if so, determines whether the laboratory services were furnished during the period of em ergency. If the emergency claim was forwarded to the appropriate MAC for processing, it enters the date received on the laboratory claim. If no emergency claim was filed, or laboratory services were not furnished in the period covered by the emergency claim, the MAC develops the claim as a possible emergency. It includes the laboratory claim with any subsequent claim. If no emergency is alleged, the MAC records on the claim that no emergency existed and disallows it. 350.9 - Nonemergency Part B Medical and Other Health Services (Rev. 3287, Issued: 06- 30-15, Effective: 04 -21-15, Implementation: 04- 21-15) A. Coverage Nonemergency services to Medicare beneficiaries may be paid for if the coverage requirements for the services are met, and are not covered as Part A emergency inpatient services. Program payment may be made for the following Part B medical and other health services furnished by a U.S. nonparticipating hospital on a nonemergency basis: Diagnostic x- ray tests, diagnostic laboratory tests and other diagnostic tests. (The hospital must meet the applicable conditions of participation for the services.) X-ray, radium, and radioactive isotope therapy, including materials and services of technicians. (The hospital must meet the applicable conditions of participation for these services.) Services of residents and interns, nurses, therapists, etc., which are directly related to the provision of x- ray or laboratory or other diagnostic tests, or the provisions of x- ray or radium therapy. Prosthetic devices (other than dental) which replace all or part of an internal body organ (including contiguous tissue) or replace all or part of the functions of a permanently inoperative or malfunctioning internal body organ, including replacement of such devices. Leg, arm, back, and neck braces, trusses and artificial legs, arms, and eyes, including replacement, if required, because of a change in the patient's physical condition. B. Distinction Between Emergency and Nonemergency Medical and Other Health Services Emergency coverage, particularly Part B emergency outpatient coverage, is broader than the nonemergency Part B Medical and Other Health Services coverage provisions. When the emergency requirements are met, program payment may be made to the hospital for the full range of outpatient hospital services. In addition to the nonemergency coverage list, emergency coverage includes hospital services (including drugs and biologicals - blood is a biological - which cannot be self -administered), "incident to physicians' services rende red to outpatients," and outpatient physical therapy and speech -language pathology. The latter two services are not covered under the nonemergency provisions. Payment for "incident to" services can be only under the emergency rather than the nonemergency provisions. Whether Part B payment is made under the emergency or nonemergency provisions, it may be made for diagnostic laboratory tests furnished by an emergency hospital only if the hospital meets the conditions of participation relating to hospital laboratories. It may be made only for radiology services furnished by an emergency hospital if the hospital meets the conditions of participation relating to radiology departments. Part B payment may be made for diagnostic laboratory tests furnished by a nonparticipati ng hospital which is not an emergency hospital only if the hospital laboratory meets the conditions of coverage of independent laboratories and for radiology services furnished by it, only if it meets the conditions of participation relating to radiology departments. C. Claims Processing

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Emergency coverage, particularly Part B emergency outpatient coverage, is broader than the nonemergency Part B Medical and Other Health Services coverage provisions. When the emergency requirements are met, program payment may be made to the hospital for the full range of outpatient hospital services. In addition to the nonemergency coverage list, emergency coverage includes hospital services (including drugs and biologicals - blood is a biological - which cannot be self -administered), "incident to physicians' services rende red to outpatients," and outpatient physical therapy and speech -language pathology. The latter two services are not covered under the nonemergency provisions. Payment for "incident to" services can be only under the emergency rather than the nonemergency provisions. Whether Part B payment is made under the emergency or nonemergency provisions, it may be made for diagnostic laboratory tests furnished by an emergency hospital only if the hospital meets the conditions of participation relating to hospital laboratories. It may be made only for radiology services furnished by an emergency hospital if the hospital meets the conditions of participation relating to radiology departments. Part B payment may be made for diagnostic laboratory tests furnished by a nonparticipati ng hospital which is not an emergency hospital only if the hospital laboratory meets the conditions of coverage of independent laboratories and for radiology services furnished by it, only if it meets the conditions of participation relating to radiology departments. C. Claims Processing The hospital enters the annotation "nonemergency- hospital accepts assignment" in Remarks of the Form CMS -1450. If it is determined that some or all of the services are not covered under the nonemergency provisions, the claim is returned to it (if hospital- filed) or to the beneficiary (if patient- filed) to determine whether the services might be covered as emergency services. 350.10 - Elections to Bill for Services Rendered By Nonparticipating Hospitals (Rev. 3287, Issued: 06- 30-15, Effective: 04 -21-15, Implementation: 04- 21-15) A. Nonparticipating U.S. Hospitals As a nonparticipating U.S. hospital meeting emergency requirements, the hospital has the option to bill the program during a calendar year by filing an election with its MAC. If it files an election, it should submit claims for the following services furnished all Medicare beneficiaries throughout the year: Emergency inpatient services; and Emergency outpatient services. In addition, the hospital may not bill any beneficiary beyond deductibles, coinsurance, and noncovered services in that calendar year. It must agree to refund any monies incorrectly collected. It may not file an election for the calendar year if it has a lready charged any beneficiary for covered services furnished in that year. If the hospital does not file a billing election, the beneficiary can file a claim. The beneficiary may request information from the hospital or the MAC as appropriate. During November of each year, the MAC will send the non- participating hospital a letter (see 360.3.1). Also, during November of each year, the MAC will send a letter to each domestic hospital, giving it an opportunity to elect to bill Medicare if it has not been doing so ( 360.3.2). If during the year the hospital requests to bill the program, its MAC will send the model letter in 360.3.3. B. Billing for Services Furnished Prior to Certification The following rules apply if a bill is submitted for services rendered before and after a hospital's certification (participation) date: PPS hospitals are paid the DRG, if the date of discharge is after the certification date. Other hospitals are paid for services rendered after the certification date. However, the hospital must include services before certification date on its cost report. It should annotate in the upper right hand corner of the claim "Emergency Conversion." C. Foreign Hospitals Foreign hospitals may submit a statement to the appropriate MAC stating that they will bill for all claims. If they do not, the beneficiary may claim the payment. When the MAC is aware that a hospital is willing to bill the program for all covered servic es, it solicits the hospital's agreement to: Bill for all covered services for the calendar year (except for deductible and coinsurance amounts); Not bill the beneficiary for any amounts other than for deductible and coinsurance and charges for noncovered services; and Refund to the beneficiary any monies incorrectly collected. A hospital may not file an election for a calendar year if it has charged any beneficiary for covered services during that year. D. Submitting Claims The beneficiary or the hospital that has elected to bill the program may submit emergency claims for payment to the appropriate MAC for evaluation of accessibility or emergency factors. The hospital completes the claim (Form CMS -1450 or electronic equivalent) according to billing instructions in chapter 25. It enters "hospital filed emergency admission" in Item 94 "Remarks." It sends the completed bill and the necessary emergency documentation (Form CMS -1771, Attending Physicians Statement and Documentation of Medicare Emergency) or medical records to substantiate the emergency to the appropriate MAC. NOTE: See 360.2, "Designated Contractors." If the hospital submits a claim but has not filed an election to bill the program, the MAC will contact the hospital to determine if it is qualified and wish to bill the program. If it declines, the claim will be denied. A claim will be solicited from th e beneficiary. If the hospital has filed a billing election and the beneficiary files a claim, the beneficiary's claim is denied and the MAC contacts the hospital regarding the claim. 350.11 - Processing Claims (Rev. 3287, Issued: 06- 30-15, Effective: 04 -21-15, Implementation: 04- 21-15) All claims are subject to development to determine whether the Medicare secondary payer provisions apply. (See Pub. 100-05, Medicare Secondary Payer Manual.) A. Nonparticipating Hospitals The processing MAC is responsible for making accessibility and medical emergency determinations for physician and ambulance services. 1. Claims Subject to Technical Denials The following claims are subject to technical denial: Foreign nonemergency services claims if: The residence requirement is not met. (See 350.5.) The hospital rendering the service does not meet Joint Commission or equivalent accreditation requirements set by a hospital approval program of the country in which it is located. The accessibility requirements are not met. (See 350.11.4.) Canadian travel claims when the requirements in 350.4 are not met. Emergency services claims for which the hospital does not meet the definition of an emergency hospital. Claims for which the query response shows the beneficiary is not entitled to benefits. Any foreign claim when Part A benefits are exhausted and Part B physician or ambulance claims are not involved. 2. Either the Accessibility or Medical Emergency Requirements are Not Met Claim is denied but retained in case of an appeal by the beneficiary. NOTE: Even though Part A or Part B emergency services furnished by U.S. hospitals are denied, Part B payment may be possible for Medical and Other Health Services specified in Pub. 100- 02, Medicare Benefit Policy Manual, chapter 6. Claim is retained in case o f an appeal by the beneficiary. 3. Emergency Services Partially Denied When the medical emergency is approved but not for the entire period, the claim is processed and payment made for the covered period. B. Foreign Part B Physician and Ambulance Claims The hospital must attach any Part B claim for foreign physician and ambulance services to the corresponding Part A claim and forward to the MAC. If the MAC determines that the inpatient services were covered, it sends the physician and/or independent ambulance claim to the designated MAC for processing and payment. (See 350.6.) If the Part A claim is denied on the basis of accessibility of medical emergency, the MAC denies the Part B claim, and sends a MSN to the beneficiary. It retains copies in case of an appeal by the beneficiary. NOTE: Even though Part A benefits are totally or partially exhausted, payment may be made by the MAC for physician and independent ambulance services furnished if all coverage requirements are met. If a Part A claim was partially denied because the emergency terminated, the MAC makes a decision on the claim and any provider -based ambulance claim. It sends copies to the appropriate MAC for processing. 350.11.1 - Contractors Designated to Process Foreign Claims (Rev. 3287, Issued: 06- 30-15, Effective: 04 -21-15, Implementation: 04- 21-15) Per contractor Statement of Work (SOW) all contractors are designated to process claims for physicians and ambulance services furnished in connection with a covered foreign hospital stay for their beneficiaries who reside in the states/areas for which they process claims. All contractors are designated to determine whether the requirements in 350.6 are met for claims for inpatient services based upon the geographic location of the foreign hospitals furnishing the services. All contractors are designated to process these claims if there is evidence that the Part B services were furnished in connection with covered foreign inpatient hospital services. If there is no evidence, the Contractor must send a front -end rejection not ice in accordance with 350.11.2. 350.11.2 - Contractor Processing Guidelines (Rev. 3287, Issued: 06- 30-15, Effective: 04 -21-15, Implementation: 04- 21-15) Per contractor Statement of Work (SOW) all contractors are responsible for processing foreign, emergency and shipboard claims for their beneficiaries who reside in the states/areas for which they process claims. The A/B MAC determines whether the requirements in 350.6.A are met. If these requirements are not met, the A/B MAC denies the Part A claim and related Part B claim and notifies the beneficiary. Where the A/B MAC determines that the requirements in 350.6.A are met, the A/B MAC determines whether other applicabl e Part A coverage requirements are met. If the A/B MAC disallows the Part A claim, it denies the related Part B claim and notifies the beneficiary. However, the A/B MAC will not be involved in the processing of foreign claims if, for any reason, the related Part A claim is denied. If the claim does not show that the beneficiary was hospitalized, the A/B MAC sends the beneficiary a front -end rejection notice. In filling out the Notification of Medicare Determination, the A/B MACs should check other and include the following explanation: Foreign physician or ambulance services are not covered unless they were furnished in connection with a covered inpatient stay. 350.11.3 - Medicare Approved Charges for Services Rendered in Canada or Mexico (Rev. 3287, Issued: 06- 30-15, Effective: 04 -21-15, Implementation: 04- 21-15) For Canadian services, the Medicare approved charge will be the lower of: 1. The allowed amount for the same service in the U.S. locality closest to where the service was furnished (as determined by the designated MAC), or 2. The Canadian Provincial fee. Therefore, the designated MAC must obtain the most recent schedule of fees published by the appropriate Canadian Province. Most of the designated MACs deal with only one Provincial schedule. For Mexican services, the maximum charge is the Medicare allowed amount for the same service in the locality closest to where the service was furnished (as determined by the designated MAC). 350.11.4 - Accessibility Criteria (Rev. 4111, Issued: 08- 10-18, Effective: 9 -11-18, Implementation: 9- 11-18) A. Emergency Claims The MAC uses the same criteria in domestic and foreign emergency claims. This includes services in a foreign religious non-medical health care institution and Canadian Travel claims. (See 350.4 and 350.9.) Emergency determinations take into account such matters as relative distances of a participating hospital, and road conditions. The MAC considers whether the nature of the emergency required immediate transportation to the nearest available hospital (i.e. , the nonparticipating hospital) or, without hazard to the patient, would have permitted the additional transportation time to take the patient to a more distant participating hospital in the same general area. The MAC does not consider in its determination such factors involving selection of a hospital which reflect the personal preferences of the individual or physician, (e.g., physician does not have staff privileges at the participating hospital) nearness to beneficiary's residence, presence of previous medical records at the nonparticipating hospital, cost, or type of accommodations available. The following sections discuss documentation of the accessibility requirement and provide guidelines for making a determination where the participating hospital is: Closer to the site of the emergency than is the admitting nonparticipating hospital; Fifteen or fewer miles farther from the site of the emergency than is the nonparticipating hospital; or Sixteen or more miles farther from the site of the emergency than is the admitting nonparticipating hospital. In urban and suburban areas, where both participating and nonparticipating hospitals are similarly available, it is presumed, in the absence of clear and convincing evidence to the contrary, that the services could have been provided in the participating h ospital. 1. Participating Hospital Closer to Site of Emergency

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The MAC does not consider in its determination such factors involving selection of a hospital which reflect the personal preferences of the individual or physician, (e.g., physician does not have staff privileges at the participating hospital) nearness to beneficiary's residence, presence of previous medical records at the nonparticipating hospital, cost, or type of accommodations available. The following sections discuss documentation of the accessibility requirement and provide guidelines for making a determination where the participating hospital is: Closer to the site of the emergency than is the admitting nonparticipating hospital; Fifteen or fewer miles farther from the site of the emergency than is the nonparticipating hospital; or Sixteen or more miles farther from the site of the emergency than is the admitting nonparticipating hospital. In urban and suburban areas, where both participating and nonparticipating hospitals are similarly available, it is presumed, in the absence of clear and convincing evidence to the contrary, that the services could have been provided in the participating h ospital. 1. Participating Hospital Closer to Site of Emergency If there is an adequately equipped participating hospital with available beds closer to the site of the emergency than the nonparticipating hospital, accessibility is not met. Claim is denied unless extenuating circumstances were present that necessitated admission to the nonparticipating hospital, e.g., because of road or traffic conditions additional travel time would have been needed. 2. Participating Hospital 15 or Fewer Miles Farther From the Location of the Emergency Than the Admitting Nonparticipating Hospital In this situation the accessibility is provisionally not met. The claim is reviewed to determine if the nature of the emergency required the immediate transportation to the nonparticipating hospital. If the review indicates that the nature of the emergen cy would have allowed the additional transportation time needed to take the patient to the participating hospital without undue hazard, the accessibility requirement is not met. The claim is denied. 3. Participating Hospital More than 15 Miles Farther From the Location of the Emergency Than the Admitting Nonparticipating Hospital The accessibility requirement is deemed met. B. Foreign Nonemergency Claims The following presumptions are applied to the relative accessibility of the nearest participating U.S. and foreign hospitals. 1. Admitting Foreign Hospital is Closer to the Beneficiary's Residence Than the Nearest Participating U.S. Hospital The accessibility requirement is met. 2. Admitting Foreign Hospital is Farther From the Beneficiary's Residence Than the Nearest Participating U.S. Hospital The accessibility requirement is not met unless evidence establishes the practical necessity for the beneficiary's admission. This requirement is met if the use of a closer participating U.S. hospital was impractical, e.g., non-availability of beds, neede d equipment or personnel, or transportation not available. In determining whether a foreign hospital is more accessible than a participating hospital, the MAC does not consider the personal preference of the beneficiary, physician, or others in the selection of a hospital, the type of accommodations available, or the nonavailability of staff privileges to the attending physician. 350.11.5 - Medical Necessity (Rev. 3287, Issued: 06- 30-15, Effective: 04 -21-15, Implementation: 04- 21-15) A. Emergency Services Reimbursement for emergency inpatient hospital services is permitted only for those periods during which the patient's state of injury or disease is such that a health or life -endangering emergency existed and continued to exist, requiring immediate care t hat could be provided only in a hospital. The allegation that an emergency existed must be substantiated by sufficient medical information from the physician or hospital. If the physician's statement does not provide it, or is not supplemented by adequat e clinical corroboration of this allegation, it does not constitute sufficient evidence. Death of the patient does not necessarily establish the existence of a medical emergency, since in some chronic, terminal illnesses, time is available to plan admission to a participating hospital. The lack of adequate care at home or lack of transportation to a participating hospital does not constitute a reason for emergency hospital admission, without an immediate threat to the life and health of the patient. Since the existence of medical necessity for emergency services is based upon the physician's assessment of the patient prior to admission, serious medical conditions developing after a non-emergency admission are not "emergencies" under the emergency services provisions of the Act. The emergency ceases when it becomes safe, from a medical standpoint, to move the individual to a participating hospital, another institution, or to discharge the individual. B. Criteria Since the decision that a medical emergency existed can be a matter of subjective medical judgment involving the entire gamut of disease and accident situations, it is impossible to provide arbitrary guidelines. 1. Diagnosis is Considered "Usually an Emergency" An emergency condition is an unanticipated deterioration of a beneficiary's health which requires the immediate provision of inpatient hospital services because the patient's chances of survival, or regaining prior health status, depends upon the speed wit h which medical or surgical procedures are, or can be, applied. While many diagnoses (e.g., myocardial infarction, acute appendicitis) are normally considered emergencies, the hospital must check medical documentation for internal consistencies (e.g., signs and symptoms upon admission, notations concerning changes in a preexisting condition, results of diagnostic tests). EXAMPLE: If the diagnosis is given as "coronary," the physician's statement is "coronary," without further explanatory remarks, and the statement of services rendered gives no indication that an electrocardiogram was taken, or that the patient required intensive care, etc., further information is required. On the other hand, if the diagnosis is one that ordinarily indicates a medical and/or surgical emergency, and the treatment, diagnostic procedures, and period of hospitalization are consistent with the diagnosis, further documentation may be unnecessary. An example is: admitting diagnosis - appendicitis; discharge diagnosis - appendicitis; surgical procedures - appendectomy; period of inpatient stay - 7 days. 2. Patient Dies During Hospitalization If an emergency existed at the time of admission and the patient subsequently expires, the claim is allowed for emergency services if the period of coverage is reasonable. However, death of the patient is not prima facie evidence that an emergency existed ; e.g., death can occur as a result of elective surgery or in the case of a chronically ill patient who has a long terminal hospitalization. Such claims are denied. 3. Patient's Physician Does Not Have Staff Privileges at a Participating Hospital The fact that the beneficiary's attending physician does not have staff privileges at a participating hospital has no bearing on the emergency services determination. If the lack of staff privileges in an accessible participating hospital is the governing factor in the decision to admit the beneficiary to an "emergency hospital," the claim is denied irrespective of the seriousness of the medical situation. 4. Beneficiary Chooses to be Admitted to a Nonparticipating Hospital The claim is denied if the beneficiary chooses to be admitted to a non- participating hospital as a personal preference (e.g., participating hospital is on the other side of town) when a bed for the required service is available in an accessible , participat ing hospital. 5. Beneficiary Cannot be Cared for Adequately at Home The patient who cannot be cared for adequately at home does not necessarily require emergency services. The claim is denied in the absence of an injury, the appearance of a disease or disorder, or an acute change in a pre -existing disease state which pose s an immediate threat to the life or health of the individual and which necessitates the use of the most accessible hospital equipped to furnish emergency services. 6. Lack of Suitable Transportation to a Participating Hospital Lack of transportation to a participating hospital does not, in and of itself, constitute a reason for emergency services. The availability of suitable transportation can be considered only when the beneficiary's medical condition contraindicates taking the time to arrange transportation to a participating hospital. The cla im is denied if there is no immediate threat to the life or health of the individual, and time could have been taken to arrange transportation to a participating hospital. 7. "Emergency Condition" Develops Subsequent to a Non- emergency Admission to a Nonparticipating Hospital Program payment cannot be made for emergency services furnished by a nonparticipating hospital when the emergency condition arises after a non- emergency admission. An example: treatment of postoperative complications following an elective surgical procedu re or treatment of a myocardial infarction that occurred during a hospitalization for an elective surgical procedure. The existence of medical necessity for emergency services is based upon the physician's initial assessment of the apparent condition of t he patient at the time of the patient's arrival at the hospital, i.e., prior to admission. 8. Additional "Emergency Condition" Develops Subsequent to an Emergency Admission to a Nonparticipating Hospital If the patient enters a nonparticipating hospital under an emergency situation and subsequently has other injuries, diseases or disorders, or acute changes in preexisting disease conditions, related or unrelated to the condition for which the patient enter ed, which pose an immediate threat to life or health, emergency services coverage continues. Emergency services coverage ends when it becomes safe from a medical standpoint to move the patient to an available bed in a participating institution or to discharge the patient, whichever occurs first. C. Documenting Medical Necessity 1. Physician's Supporting Statement Claims for emergency services by a non -participating hospital should be accompanied by an Attending Physician's Statement and Documentation of Medicare Emergency, Form CMS -1771 or its equivalent. This form describes the nature of the emergency, furnishing relevant clinical information about the patient, and certifying that the services rendered were required as emergency services. However, a copy of the patient's hospital records may be submitted instead. It should include history, physical, and admission notes, the medical record admission sheet, nurses' notes, doctors' orders, discharge summary, and all progress notes. A statement that an emergency existed, or the listing of diagnoses, without supporting information, is not sufficient. In addition, the statement must include the date, in the physician's judgment, the emergency ceased. The physician who attended the patient at the hospital makes the statement concerning emergency services. Only in exceptional situations, with appropriate justification, may another physician having full knowledge of the case, make the certification. 2. Beneficiary's Statement in Canadian Travel Claims In Canadian travel claims, the beneficiary's statement is considered in making a determination regarding medical necessity for emergency services; i.e., whether an emergency occurred while a beneficiary was traveling between Alaska and another State by the most direct route without unreasonable delay. (See 350.4.) 350.11.6 - Time Limitation on Emergency and Foreign Claims (Rev. 3287, Issued: 06- 30-15, Effective: 04 -21-15, Implementation: 04- 21-15) The regular time limits apply to requests and claims for payment for emergency hospital services and hospital services outside the U.S., for physician and ambulance services furnished in connection with foreign hospitalization, and for nonemergency service s furnished by a domestic nonparticipating hospital. See chapter 1 for a description of these requirements. A. Beneficiary Denial Notices MACs shall send denial letters for non- covered foreign related claims. Part B MACs will send an MSN for covered foreign emergency and shipboard claims related to a covered Part A foreign claim. An MSN is also sent for shipboard services provided within US territories. B. Termination of Emergency Services No payment will be made for inpatient or outpatient emergency services rendered after a reasonable period of medical care in relation to the emergency condition in question. Some services may be covered in a domestic nonparticipating hospital as Part B Me dical and Other Health Services. (See the Medicare Benefit Policy Manual, chapter 6.) If, based upon all information, the total period claimed for emergency services coverage does not exceed the time required for a reasonable period of emergency medical care, the entire inpatient stay is covered. The fact that a medical record or other information states that the patient showed definite improvement several days prior to discharge is not necessarily an indication that the need for emergency services ceased as of that date. The concept of a reasonable period of emergency medical care is most easily applied when relatively short -term medical care is followed by the patients progressive improvement. There are situations or conditions in which the determina tion of the end of covered emergency services may be more difficult because the patients impairment is prolonged, there is no progressive improvement, or the patients course may be progressively downhill, even though the condition is not critical. The s troke patient may be in this category. In such cases the need for emergency medical care usually ceases before the need for medical care in an institutional setting (i.e., hospital or SNF) ceases. Thus, the reasonable period of emergency care does not include the entire hospital stay if the stay was prolonged beyond the point when major diagnostic evaluation and treatment were carried out.

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The MAC will make the determination based upon all information available. As a general rule, if the period claimed for emergency services exceeds by more than 3 to 5 days the date on which the record definitely indicates that there was substantial improve ment in the patients condition so that the patient could possibly have been moved to a participating facility or discharged without damage to health, the period beyond the 3 to 5 days is denied. If the total period claimed for emergency services exceeds by no more than 3 to 5 days the date on which the record indicates substantial improvement in the patients condition, the entire period is allowed. This rule is intended to screen out short stay emergency hospitalization cases in which the patient was either discharged or transferred to a participating provider within a reasonable time after the medical record definitely indicated substantial improvem ent in the patients condition. The reasonable period of emergency care is that period required to provide relief of acute symptoms or for initial management of the condition while arrangements are made for definitive treatment. Two examples: Prostatic hypertrophy which results in acute urinary retention; and Mental illness with suicidal and/or homicidal tendencies. In acute urinary retention, the reasonable period of emergency medical care includes the period required for catheterization and stabilization of the patient. The patient could then be transferred to a participating hospital for surgery or other required treatment. For the suicidal or homicidal patient, a reasonable period of emergency medical care includes the time required for initial management of the case while arrangements are made for transfer (by commitment or otherwise) to a participating hospital. A period of 24 to 48 hours of emergency care is usually sufficient in both cases. 350.11.7 Payment Denial for Medicare Services furnished to Alien Beneficiaries Who are Not Lawfully Present in the United States (Rev. 3287, Issued: 06- 30-15, Effective: 04 -21-15, Implementation: 04- 21-15) Medicare payment may not be made for items and services furnished to an alien beneficiary who was not lawfully present in the United States on the date of service. The CWF must establish an auxiliary file based on enrollment data contained in the Enrollment Data Base maintained by the Centers for Medicare & Medicaid Services in order to appropriately edit the claims specifically associated with alien beneficiaries. The auxiliary file will be the basis for an edit that rejects claims for a beneficiary that was not lawfully present in the U.S. on the date of service. MACs and DMACs must deny claims for items and services, rejected by CWF on the basis that the benefici ary was not lawfully present in the U.S. on the date of service. MACs and DMACs must refer to the CWF documentation on this subject for the error code MSN Message 5.7, assigned to this editing. Upon receipt of an error code MSN Message 5.7, A/B MACs, DME MACs, and A/B MACs (HHH) must deny the claim and use reason code (CARC) 177 Patient has not met the required eligibility requirements. When CWF rejects a claim, MACs and DMACs must use MSN message 5.7, Medicare payment may not be made for the item or service because, on the date of service, you were not lawfully present in the United States. 5.7, Medicare no puede pagar por este artculo o servicio porque, en la fecha en que lo recibi, ust ed no estaba legalmente en los Estados Unidos. A party to a claim denied in whole or in part under this policy may appeal the initial determination on the basis that the beneficiary was lawfully present in the United States on the date of service. In addition, this same information must be published in your next regularly scheduled bulletin. If you have a listserv that targets the affected provider communities, you must use it to notify subscribers that information Medicare Services for Alien Bene ficiaries Lawfully present the United States is avail able on your Web site. NOTE : Section 401 of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA), codified at 8 U.S.C. 1611, prohibits aliens who are not qualified aliens from receiving Federal public benefits including Medicare. However, Section 5561 of the Balanced Budget Act of 1997 (BBA) amended Section 401 of the PRWORA to create a Medicare exemption to the prohibition on eligibility for non- qualified alien beneficiaries, who are lawfully present in the United States and who m eet certain other conditions. Specifically, payment may be made for services furnished to an alien who is lawfully present in the United States (and provided that with respect to benefits payable under Part A of Title XVIII of the Social Security Act [42 U.S.C. 1395c et seq.], who was authorized to be employed with respect to any wages attributable to employment which are counted for purposes of eligibility for Medicare benefits). The definition for lawfully present in the United States is found at 8 CF R 1.3. 350.12 - Appeals on Claims for Emergency and Foreign Services (Rev. 3287, Issued: 06- 30-15, Effective: 04 -21-15, Implementation: 04- 21-15) When a MAC receives a beneficiary appeal of a claim submitted by the beneficiary for services provided by a non-participating provider, the MAC will process the appeal in accordance with the guidelines in Pub. 100- 04 chapter 29. When a MAC receives an appeal from a non -participating provider of a claim that was submitted by, or on behalf of, a beneficiary, the MAC shall dismiss the appeal request as the non -participating provider is not a proper party. The MAC shall send a copy of the dismissal to the beneficiary. A non- participating provider does not have standing to file an appeal for the individual claims for payment it submits on behalf of a beneficiary, or for claims the beneficiary submits for services it has furnished. See , 42 CFR 405.906(a)(3) and 405.902 (for the definition of provider); Pub. 100- 04, chapter 29, 210 and the glossary in Pub. 100- 04, chapter 29, 110 (for the definition of provider). Only a beneficiary (or the beneficiarys authorized representative, or an appointed representative on behalf of the beneficiary) can appeal claim determinations for services furnished by a non- participating provider. NOTE: Non -participating providers have appeal rights under the provider and supplier enrollment appeals process in 42 CFR Part 498 for MAC determinations related to the non- participating providers election to file claims (see 350.10). NOTE: The RRB conducts Part B redeterminations under the Railroad Retirement Act for services rendered in Canada. 360 - Payment for Services Received By Nonparticipating Providers (Rev. 3287, Issued: 06- 30-15, Effective: 04 -21-15, Implementation: 04- 21-15) The condition of payment regulations for emergency services received in Nonparticipating Providers can be found in the 42 CFR 424.100- 109, Subpart G Special Conditions: Emergency Services Furnished by a Nonparticipating Hospital. The Form CMS -1450 or its electronic equivalent must be used. A. Hospital Filed Claims 1. Inpatient Services The payment rate for inpatient claims is 100 percent of the nonparticipating providers customary charges (see 42 C.F.R. 413.74(b) and 42 C.F.R. 424.104(a)(3)). The cost of the services is adjusted by any applicable deductible and coinsurance amounts for which the beneficiary is responsible. Payment will be made to Federal hospitals that furnish emergency services, on an inpatient basis, to individuals entitled to hospital benefits. Payment will be based on the lower of the actual charges from the hospital or rates published for Federal hospi tals in the Federal Register under Office of Management and Budget - Cost of Hospital and Medical Care and Treatment Furnished by the United States; Certain Rates Regarding Recovery from Tortiously Liable Third Persons. Medicare will not pay federal hospitals for emergency items or services furnished to veterans, retired military personnel or eligible dependents. However, Medicare can pay for the inpatient deductible charged by VA hospitals, or credit that amount to the Medicare Part A deductible, for emergency services furnished to veterans. If a Part A claim is denied, a denial notice will be forwarded to the beneficiary from the MAC. The beneficiary can use this notice to forward to their private insurer, if applicable. The VA or Department Of Defense hospital must file a statement of election for each calendar year to receive direct payment from Medicare for all claims filed that year. 2. Outpatient Services The amount paid by Medicare for emergency outpatient claims is obtained as follows: Eighty- five percent of the total covered charges is the estimated cost figure. The applicable Part B deductible is subtracted. Coinsurance is subtracted from the remainder. Subtracting the deductible from 85 percent of the total covered charges and applying the 20 percent coinsurance rate to the remainder obtains the patients coinsurance amount. The hospital will be paid cost (85 percent of covered charges) minus deductible and coinsurance. 3. Part B Medical and Other Health Services Part B medical and other health services, including hospital -based ambulance services whether hospital or beneficiary filed, may be covered and paid on a non- emergency basis. To calculate the amount paid by Medicare, the hospital subtracts the Part B deductible from the total covered charges and applies the 80 percent payment rate. 4. Special Letters for Partially or Totally Denied (Hospital- Filed) Claims for Emergency Inpatient Services The patient receives a notice from CMS covering the emergency payment of a partially denied claim. A denial letter and a Part B explanation of benefits is sent to the patient. The MAC includes its address on this letter. B. Beneficiary Filed Claim 1. Emergency Inpatient Claims The payment computation follows: Any noncovered accommodation charge is subtracted from the total accommodation charges. The amount of the inpatient deductible or coinsurance met on this bill is subtracted. Any remainder is multiplied by 60 percent. The total noncovered ancillary charge is subtracted from the total ancillary charge. Any inpatient deductible or coinsurance that remains is subtracted. The remainder is multiplied by 80 percent. The benefit amounts obtained are added. 2. Emergency Outpatient Services To calculate the amount paid by Medicare, the hospital must subtract any applicable Part B deductible from the total covered charges and apply the 80 percent payment rate. 3. Part B Medical and Other Health Services Part B medical and other health services furnished by nonparticipating hospitals, including hospital -based ambulance services, may be covered and paid on a non- emergency basis. To calculate the amount paid by Medicare, the hospital must subtract any applicable Part B deductible from the total covered charges and apply an 80 percent payment rate. 4. Special Letters for Patient -Filed Claims for Emergency Inpatient Services For emergency admissions to nonparticipating hospitals where direct payment is made to the patient, the MAC sends the beneficiary one of the letters described below, as appropriate. The letter explains the Part A payments made. Part B payments are made for ancillary services not covered by Part A and are also explained in a letter. This letter also explains the beneficiarys right of appeal. The MAC retains a duplicate of all notices sent for documentation in any appeals process. It enters the date the notice is released on both copies of all notices. Sample paragraphs: Enclosed is a check for $______, which is the amount Medicare can pay for inpatient hospital services you received from (date of admission) to (date of discharge) in (hospital). Medicare is able to pay 60 percent of the charges for your room and board plus 80 percent of the charges for all other covered services during the period (date emergency began) to (date payment ended). Medicare is able to pay 60 percent of the charges for your room and board, 80 percent of the charges for other separately identified charges, and 66 2/3 percent of the other charges which were not separately identified on the hospital bill. Medicare does not pay (the first $ ____ of charges) (the first three pints of blood) ($ ____ a day after the 60th day) in a benefit period. (Select one or more, if applicable.) If lifetime reserve days are used, add $ ___ a day from ________ to _________. If you believe your Medicare hospital insurance should have covered all or more of your expenses, you may get in touch with us at the address shown on this letter. If you believe that the determination is not correct, you may request a reconsideration for hospital insurance (or a review for medical insurance). You may make the request by mail to the address shown on this letter. If you come in person, please bring this notice with you. This check includes a medical insurance payment for 80 percent of the charges for certain nonroutine hospital services which you received from _______ through _______. These services are listed on the enclosed form.

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Medicare is able to pay 60 percent of the charges for your room and board, 80 percent of the charges for other separately identified charges, and 66 2/3 percent of the other charges which were not separately identified on the hospital bill. Medicare does not pay (the first $ ____ of charges) (the first three pints of blood) ($ ____ a day after the 60th day) in a benefit period. (Select one or more, if applicable.) If lifetime reserve days are used, add $ ___ a day from ________ to _________. If you believe your Medicare hospital insurance should have covered all or more of your expenses, you may get in touch with us at the address shown on this letter. If you believe that the determination is not correct, you may request a reconsideration for hospital insurance (or a review for medical insurance). You may make the request by mail to the address shown on this letter. If you come in person, please bring this notice with you. This check includes a medical insurance payment for 80 percent of the charges for certain nonroutine hospital services which you received from _______ through _______. These services are listed on the enclosed form. If a hospital bill is not itemized, Medicare can pay 66 2/3 percent of the total covered charges. Payment is being made at this rate for charges from (date emergency began) to (date payment ended). We are enclosing a check for $ ______. This is your payment under Part B for 80 percent of the charges for the services which you received from (admission date) through (discharge date) while in (name of hospital). These services are listed on the enclo sed form. When payment cannot be made under hospital insurance, medical insurance covers some, but not all, of the hospital services. Room and board and certain other services are not covered by medical insurance. 360.1 - Payment for Services from Foreign Hospitals (Rev. 3287, Issued: 06- 30-15, Effective: 04 -21-15, Implementation: 04- 21-15) The condition of payment regulations for emergency services received in Nonparticipating Providers can be found in the 42 CFR 424.100- 109, Subpart G Special Conditions: Emergency Services Furnished by a Nonparticipating Hospital A. Hospital Filed Claim A foreign hospital that elects to bill the Medicare program receives 100 percent of its customary charges, subject to applicable deductible and coinsurance amounts. The hospital establishes its customary charges for the services by submitting an itemized bill with each claim. This eliminates the need to file a cost report. Regardless of the billing form used, the MAC must: Recode the bill using revenue codes for the Form CMS-1450; Prepare an HUIP or HUOP input record for CWF; and Send a Medicare Summary Notice (MSN) to the beneficiary. The nonparticipating hospital must file a statement of election for each calendar year to receive direct payment from Medicare for all claims filed that year. Payment is subject to the official exchange rate on the date the patient is discharged. B. Beneficiary Filed Claim To calculate the amount paid by Medicare for Part B Hospital -Based Ambulance Claims, the hospital must subtract any unmet Part B deductible from the total covered charges and apply the 80 percent payment rate. Payment to the beneficiary is subject to the official exchange rate on the date of discharge. 360.1.1 - Attending Physicians Statement and Documentation of Medicare Emergency (Rev. 4111, Issued: 08-10- 18, Effective: 9 -11-18, Implementation: 9-11-18) Form CMS -1771 - go to https://www.cms.gov/Medicare/CMS -Forms/CMS -Forms/CMS -Forms -List.html 360.2 - Designated Contractors (Rev. 3287, Issued: 06- 30-15, Effective: 04-21-15, Implementation: 04-21-15) Per Contractor Statement of Work (SOW) all contractors are designated to process claims for physicians and ambulance services furnished in connection with a covered hospital stay in Canada and Mexico for their beneficiaries who reside in the states/areas for which they process claims. 360.3 - Model Letters, Nonparticipating Hospital and Emergency Claims (Rev. 3287, Issued: 06- 30-15, Effective: 04-21-15, Implementation: 04-21-15) 360.3.1 - Model Letter to Nonparticipating Hospital That Elected to Bill For Current Year (Rev.3287, Issued: 6-30- 15, Effective:04 -21-15, Implementation: 04-21-15) DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES REFER TO: Identification Number:___________________ Dear _________________: Your election to bill the Medicare program for emergency services furnished to Medicare beneficiaries will expire on December 31. Payment for emergency services can be made to a nonparticipating hospital only if the hospital elects to receive reimbursement from Medicare for all emergency services furnished to Medicare beneficiaries in a calendar year. If you elect to bill the program, please return to us in the enclosed self -addressed envelope a statement signed by an authorized official of your hospital stating that you elect to claim payment under the Medicare program. An election to bill cannot be w ithdrawn during the year. If a statement is not received by December 31, we will assume that you do not wish to continue to bill the program at this time. However, you still retain the right to elect to bill the program at any time during the coming year if, when you make your election, you have not yet charged any Medicare beneficiary in that year for emergency hospital services rendered to him. Hospitals electing to bill the program for emergency services may obtain information on reimbursement by contacting the MAC serving nonparticipating hospitals in your State. If you do not elect to bill, the beneficiary may apply for reimbursement by submi tting an itemized bill. Please contact us if you need any further information. In addition, if at any time you decide to request full participation as a provider of hospital services under the Medicare program, please contact your Medicare MAC for complete particulars. Sincerely, 360.3.2 - Model Letter to Nonparticipating Hospital That Did Not Elect to Bill for Current Year (Rev. 3287, Issued: 06- 30-15, Effective: 04 -21-15, Implementation: 04- 21-15) DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES REFER TO: Identification Number:______________________ Dear ___________________: Under the Medicare program, hospital benefits ordinarily can be paid only for care furnished to patients of hospitals that are participating in the program. However, the program can also pay for hospital services furnished to a beneficiary who is admitted to a nonparticipating hospital in an emergency. To receive payments for emergency services, a nonparticipating hospital must meet certain conditions specified in the law. We have determined that your hospital meets these condi tions. Payment for emergency services can be made to a nonparticipating hospital only if the hospital elects to receive reimbursement from Medicare for all emergency services furnished to Medicare beneficiaries in a calendar year. Although your hospital did not elect to bill the program for the current calendar year, you may wish to bill for the coming year. If you so choose, please have an authorized official of your hospital sign a statement to this effect and return in the enclosed self -addressed envelope. R etain a copy for your records. An election to bill cannot be withdrawn during the year. If we have not received a statement from you by December 31, we will assume that you do not wish to bill the program at this time. However, you still retain the right to elect to bill the program at any time during the coming year if, when you make your e lection, you have not yet charged any Medicare beneficiary in that year for emergency hospital services rendered to him. Hospitals electing to bill the program for emergency services may obtain information on reimbursement by contacting us. If a hospital does not elect to bill, the beneficiary may apply for reimbursement by submitting an itemized bill. If at any time you decide to request full participation as a provider of hospital services under the Medicare program, please contact your Medicare intermediary for complete particulars. Sincerely, 360.3.3 - Model Letter to Nonparticipating Hospital That Requests to Bill the Program (Rev. 3287, Issued: 06- 30-15, Effective: 04 -21-15, Implementation: 04- 21-15) DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES REFER TO: Identification Number:______________________ Dear ____________________: This refers to your inquiry concerning payment for emergency hospital services rendered to a Medicare beneficiary in a hospital which is not participating in the Medicare program. Under the Medicare program, hospital benefits ordinarily can be paid only f or care furnished to patients of hospitals that are participating in the program. However, the program can also pay for hospital services furnished to a beneficiary who is admitted to a nonparticipating hospital in an emergency. To receive payments for emergency services, a nonparticipating hospital must meet certain conditions specified in the law. We have determined that your hospital meets these conditions. Payment for emergency services can be made to a nonparticipating hospital only if you elect to receive reimbursement from Medicare for all emergency services furnished to Medicare beneficiaries in a calendar year. Your hospital may now choose to bill the program for all emergency services furnished to Medicare beneficiaries during the current calendar year, if you have not yet charged any Medicare beneficiary this year for emergency hospital services rendered to him. If you so choose, please have an authorized official of your hospital sign a statement to this effect and return in the enclosed self -addressed envelope. Retain a copy for your records. An election to bill cannot be withdrawn during the year. Hospitals electing to bill the program for emergency services may obtain information on reimbursement by contacting us. If you do not elect to bill, the beneficiary may apply for reimbursement by submitting an itemized bill. If at any time you decide to request full participation as a provider of hospital services under the Medicare program, please contact your Medicare intermediary for complete particulars. Sincerely, 360.3.4 - Full Denial - Hospital -Filed or Beneficiary -Filed Emergency Claim (Rev. 4203, Issued: 01- 18-19, Effective: 02 -19-19, Implementation: 02- 19-19) The term Medicare beneficiary identifier (Mbi) is a general term describing a beneficiary's Medicare identification number. For purposes of this manual, Medicare beneficiary identifier references both the Health Insurance Claim Number (HICN) and the Medica re Beneficiary Identifier (MBI) during the new Medicare card transition period and after for certain business areas that will continue to use the HICN as part of their processes. Contractors shall include beneficiary appeal rights language and include in the mailing a redetermination request form where applicable. MODEL DENIAL NOTICE A (MAC'S NAME AND ADDRESS) Date: ______________ Beneficiary: ____________________ Claim Number ________________ DETERMINATION ON EMERGENCY HOSPITAL SERVICES We are sorry, but payment cannot be made for your stay from _______ through _______ at (hospital). This is because the (hospital) does not participate in the Medicare program and it has been determined that your treatment there does not qualify as emergency care. Under the law, payment for services received in a nonparticipating hospital can be made only if you go, or are brought to, the hospital to receive emergency care. Emergency care under Medicare is defined as: a. Care which is necessary to prevent the death or serious impairment to the health of the individual; and b. Which, because of threat to the life or health of the individual, requires the use of the nearest hospital (in miles or travel time) that has a bed available and is equipped to handle the emergency. The medical facts of your hospital admission and stay have been carefully reviewed. Based upon this review, we have found that, although it was necessary for you to be hospitalized, a medical emergency did not exist. There would have been time for you to have been admitted to a hospital participating in Medicare. If you have questions about this notice, you may call 1- 800-MEDICARE (1 -800-633-4227) for additional information. If you believe the determination is not correct, you may request a redetermination. You must file your request within 120 days from the date you receive this notice. A request for a redetermination must be filed either on Form CMS -20027 or on a written request that includes all of the elements listed below. Beneficiary name Medicare beneficiary identifier Specific service and/or item(s) for which a redetermination is being requested Specific date(s) of service Signature of the beneficiary or the beneficiarys authorized or appointed representative. You may send the request to our address above. Please keep a copy of any written correspondence for your files.

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b. Which, because of threat to the life or health of the individual, requires the use of the nearest hospital (in miles or travel time) that has a bed available and is equipped to handle the emergency. The medical facts of your hospital admission and stay have been carefully reviewed. Based upon this review, we have found that, although it was necessary for you to be hospitalized, a medical emergency did not exist. There would have been time for you to have been admitted to a hospital participating in Medicare. If you have questions about this notice, you may call 1- 800-MEDICARE (1 -800-633-4227) for additional information. If you believe the determination is not correct, you may request a redetermination. You must file your request within 120 days from the date you receive this notice. A request for a redetermination must be filed either on Form CMS -20027 or on a written request that includes all of the elements listed below. Beneficiary name Medicare beneficiary identifier Specific service and/or item(s) for which a redetermination is being requested Specific date(s) of service Signature of the beneficiary or the beneficiarys authorized or appointed representative. You may send the request to our address above. Please keep a copy of any written correspondence for your files. Sincerely, 360.3.5 - Partial Denial - Hospital- Filed or Beneficiary -Filed Emergency Claim (Rev. 4203, Issued: 01- 18-19, Effective: 02 -19-19, Implementation: 02- 19-19) The term Medicare beneficiary identifier (Mbi) is a general term describing a beneficiary's Medicare identification number. For purposes of this manual, Medicare beneficiary identifier references both the Health Insurance Claim Number (HICN) and the Medica re Beneficiary Identifier (MBI) during the new Medicare card transition period and after for certain business areas that will continue to use the HICN as part of their processes. MODEL DENIAL NOTICE A (MAC'S NAME AND ADDRESS) Date: ______________ Beneficiary: ____________________ Claim Number ________________ DETERMINATION ON EMERGENCY HOSPITAL SERVICES This refers to your request for payment under Medicare for the services received while a patient at (hospital), from _______ through _______. Payment can be made under the hospital insurance part of Medicare only for the costs of your hospitalization from _______ to _______. The (hospital) does not participate in the Medicare program. Under the law, payment for services received in a nonparticipating hospital can be made only if you go, or are brought to, the hospital to receive emergency care. Emergency care under Medicare is defined as: a. Care which is necessary to prevent the death or serious impairment to the health of the individual; and b. Which, because of threat to the life or health of the individual, requires the use of the nearest hospital (in miles or travel time) which has a bed available and is equipped to handle the emergency. Payment for emergency services stops when the emergency ends and it is permissible, from a medical standpoint, either to transfer the patient to a participating hospital or to discharge him. The medical facts of your hospital admission and stay have been carefully reviewed. Based upon this review, we have found that an emergency condition existed when you were admitted. However, the medical information indicates that this emergency condition ended on ________. At that time, your condition had improved to the extent that you could have been transferred to a hospital participating in the Medicare program. If you have questions about this notice, you may call 1- 800-MEDICARE (1 -800-633-4227) for additional information. If you believe the determination is not correct, you may request a redetermination. You must file your request within 120 days of the date you receive this notice. A request for a redetermination must be filed either on Form CMS -20027 or on a written request that includes all of the elements listed below. Beneficiary name Medicare beneficiary identifier Specific service and/or item(s) for which a redetermination is being requested Specific date(s) of service Signature of the beneficiary or the beneficiarys authorized or appointed representative. You may send the request to our address listed above. Please keep a copy of any written correspondence for your files. Sincerely, 360.3.6 - Denial - Military Personnel/Eligible Dependents (Rev. 4203, Issued: 01- 18-19, Effective: 02 -19-19, Implementation: 02- 19-19) The term Medicare beneficiary identifier (Mbi) is a general term describing a beneficiary's Medicare identification number. For purposes of this manual, Medicare beneficiary identifier references both the Health Insurance Claim Number (HICN) and the Medica re Beneficiary Identifier (MBI) during the new Medicare card transition period and after for certain business areas that will continue to use the HICN as part of their processes. MODEL DENIAL NOTICE A (MAC'S NAME AND ADDRESS) Date: ______________ Beneficiary: ____________________ Claim Number ________________ DETERMINATION ON EMERGENCY HOSPITAL SERVICES We are sorry, but payment cannot be made for your stay from________ through________ at (hospital). Under the law, medical services that have been furnished by a federal hospital to retired members of the armed services, or their eligible dependents, are not covered under the Medicare program. If you have questions about this notice, you may call 1- 800-MEDICARE (1 -800-633-4227) for additional information. If you believe the determination is not correct, you may request a redetermination. You must file your request within 120 days from the date you receive this notice. A request for a redetermination must be filed either on Form CMS -20027 or on a written request that includes all of the elements listed below. Beneficiary name Medicare beneficiary identifier Specific service and/or item(s) for which a redetermination is being requested Specific date(s) of service Signature of the beneficiary or the beneficiarys authorized or appointed representative. You may send the request to our address listed above. Please keep a copy of any written correspondence for your files. Sincerely, 360.3.7 - Full Denial - Shipboard Claim - Beneficiary Filed (Rev. 4203, Issued: 01- 18-19, Effective: 02 -19-19, Implementation: 02- 19-19) The term Medicare beneficiary identifier (Mbi) is a general term describing a beneficiary's Medicare identification number. For purposes of this manual, Medicare beneficiary identifier references both the Health Insurance Claim Number (HICN) and the Medicare Beneficiary Identifier (MBI) during the new Medicare card transition period and after for certain business areas that will continue to use the HICN as part of their processes. MODEL DENIAL NOTICE (MACS NAME AND ADDRESS) Date: ____________________ Beneficiary: _________________________ Claim Number: __________________ DETERMINATION ON SHIPBOARD SERVICES We are sorry, but medical services provided on the (vessel/ship's name) cruise ship are not covered. The Medicare program can make payment for medically necessary shipboard services only if all of the following requirements are met: 1. The services are furnished while the ship is within the territorial waters of the United States (in a U.S. port, or within 6 hours of departure or arrival at a U.S. port). 2. The services are furnished to an individual who is entitled to Part B benefits; 3. The services are furnished in connection with covered inpatient hospital services; 4. The services furnished on the ship are for the same condition that required inpatient admission; 5. The physician is legally authorized to practice in the country where he or she furnishes the services. If you have a supplemental insurance policy, you should check with the company carrying that policy to see if they cover these services and what procedures you should follow in submitting your claim. If you have questions about this notice, you may call 1- 800-MEDICARE (1 -800-633-4227) for additional information. If you believe the determination is not correct, you may request a redetermination. You must file your request within 120 days from the date you receive this notice. A request for a redetermination must be filed either on Form CMS -20027 or on a written request that includes all of the elements listed below. Beneficiary name Medicare beneficiary identifier Specific service and/or item(s) for which a redetermination is being requested Specific date(s) of service Signature of the beneficiary or the beneficiarys authorized or appointed representative. You may send the request to our address listed above. Please keep a copy of any written correspondence for your files. Sincerely, 360.3.8 - Full Denial - Foreign Claim - Beneficiary Filed (Rev. 4203, Issued: 01- 18-19, Effective: 02 -19-19, Implementation: 02- 19-19) The term Medicare beneficiary identifier (Mbi) is a general term describing a beneficiary's Medicare identification number. For purposes of this manual, Medicare beneficiary identifier references both the Health Insurance Claim Number (HICN) and the Medicare Beneficiary Identifier (MBI) during the new Medic are card transition period and after for certain business areas that will continue to use the HICN as part of their processes. MODEL DENIAL NOTICE (MACS NAME AND ADDRESS) Date: Beneficiary: Claim Number: DETERMINATION ON FOREIGN HOSPITAL SERVICES We are sorry, but payment cannot be made for your stay from through at (hospital) in (country). Medicare law prohibits payment for items and services furnished outside the United States except in certain limited circumstances . The term outside the U.S. means anywhere other than the 50 states of the U.S., the District of Columbia, Puerto Rico, the U.S. Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands. There are three situations when Medicare may pay for certain types of health care services rendered in a foreign hospital (a hospital outside the U.S.): 1. Youre in the U.S. when you have a medical emergency and the foreign hospital is closer than the nearest U.S. hospital that can treat your illness or injury. 2. Youre traveling through Canada without unreasonable delay by the most direct route between Alaska and another state when a medical emergency occurs, and the Canadian hospital is closer than the nearest U.S. hospital that can treat your illness or injury. Medicare determines what qualifies as without unreasonable delay on a case -by-case basis. 3. You live in the U.S. and the foreign hospital is closer to your home than the nearest U.S. hospital that can treat your medical condition, regardless of whether its an emergency. In these situations, Medicare will pay only for the Medicare-covered services you get in a foreign hospital. If you have a supplemental insurance policy, you should check with the company carrying that policy to see if they cover these services and what procedures you should follow in submitting your claim. If you have questions about this notice, you may call 1-800- MEDICARE (1 -800-633-4227) for additional information. If you believe the determination is not correct, you may request a redetermination. You must file your request within 120 days from the date you receive this notice. A request for a redetermination must be filed either on Form CMS -20027 or on a written request that includes all of the elements listed below. Beneficiary name Medicare beneficiary identifier Specific service and/or item(s) for which a redetermination is being requested Specific date(s) of service Signature of the beneficiary or the beneficiarys authorized or appointed representative. You may send the request to our address listed above. Please keep a copy of any written correspondence for your files. Sincerely, 370 Microvolt T -wave Alternans (MTWA) (Rev. 3265, Issued: 05- 22-15, Effective: 01 -13-15, Implementation: 06-23-15) On March 21, 2006, the Centers for Medicare & Medicaid Services (CMS) began national coverage of microvolt T -wave Alternans (MTWA) diagnostic testing when it was performed using only the spectral analysis (SA) method for the evaluation of patients at risk for sudden cardiac death (SCD) from ventricular arrhythmias and patients who may be candidates for Medicare coverage of the placeme nt of an implantable cardiac defibrillator (ICD). Effective for claims with dates of service on and after January 13, 2015, Medicare Administrative Contractors (MACs) may determine coverage of MTWA diagnostic testing when it is performed using methods of analysis other than SA for the evaluation of patients at risk for SCD from ventricular arrhythmias. Further information can be found at Publication 100-03, section 20.30, of the National Coverage Determinations Manual. 370.1 - Coding and Claims Processing for MTWA (Rev. 12396; Issued: 12- 07-23; Effective: 01 -09-24; Implementation: 01 -09-24)

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Sincerely, 370 Microvolt T -wave Alternans (MTWA) (Rev. 3265, Issued: 05- 22-15, Effective: 01 -13-15, Implementation: 06-23-15) On March 21, 2006, the Centers for Medicare & Medicaid Services (CMS) began national coverage of microvolt T -wave Alternans (MTWA) diagnostic testing when it was performed using only the spectral analysis (SA) method for the evaluation of patients at risk for sudden cardiac death (SCD) from ventricular arrhythmias and patients who may be candidates for Medicare coverage of the placeme nt of an implantable cardiac defibrillator (ICD). Effective for claims with dates of service on and after January 13, 2015, Medicare Administrative Contractors (MACs) may determine coverage of MTWA diagnostic testing when it is performed using methods of analysis other than SA for the evaluation of patients at risk for SCD from ventricular arrhythmias. Further information can be found at Publication 100-03, section 20.30, of the National Coverage Determinations Manual. 370.1 - Coding and Claims Processing for MTWA (Rev. 12396; Issued: 12- 07-23; Effective: 01 -09-24; Implementation: 01 -09-24) Effective for claims with dates of service on and after March 21, 2006, MACs shall accept CPT 93025 (MTWA for assessment of ventricular arrhythmias) for MTWA diagnostic testing for the evaluation of patients at risk for SCD with the SA method of analysis only. All other methods of analysis for MTWA are non -covered. Effective for claims with dates of service on and after January 13, 2015, MACs shall at their discretion determine coverage for CPT 93025 for MTWA diagnostic testing for the evaluation of patients at risk for SCD with methods of analysis other than SA. The KX modifier shall be used as an attestation by the practitioner and/or provider of the service that documentation is on file verifying the MTWA was performed using a method of analysis other than SA for the evaluation of patients at risk for SCD from ven tricular arrhythmias and that all other NCD criteria was met. NOTE: The KX modifier is NOT required on MTWA claims for the evaluation of patients at risk for SCD if the SA analysis method is used. NOTE: This diagnosis code list/translation was approved by CMS/Coverage. It may or may not be a complete list of covered indications/diagnosis codes that are covered but should serve as a finite starting point. As this policy indicates, individual A/B MACs within their respective jurisdictions have the discretion to make coverage determinations they deem reasonable and necessary under section 1862(a)(1)(A) of the Social Security Act. Therefore, A/B MACs may have additional covered diagnosis codes in their individual policies where contractor discretion is appropriate. ICD -10-Codes: ICD-10 CM ICD-10 DX Description I21.01 ST elevation (STEMI) myocardial infarction involving left main coronary artery I21.02 ST elevation (STEMI) myocardial infarction involving left anterior descending coronary artery I21.09 ST elevation (STEMI) myocardial infarction involving other coronary artery of anterior wall I21.11 ST elevation (STEMI) myocardial infarction involving right coronary artery I21.19 ST elevation (STEMI) myocardial infarction involving other coronary artery of inferior wall I21.21 ST elevation (STEMI) myocardial infarction involving left circumflex coronary artery I21.29 ST elevation (STEMI) myocardial infarction involving other sites I21.3 ST elevation (STEMI) myocardial infarction of unspecified site I21.4 Non-ST elevation (NSTEMI) myocardial infarction I21.A1 Myocardial infarction type 2 I21.B Myocardial infarction with coronary microvascular dysfunction I22.0 Subsequent ST elevation (STEMI) myocardial infarction of anterior wall I22.1 Subsequent ST elevation (STEMI) myocardial infarction of inferior wall I22.2 Subsequent non -ST elevation (NSTEMI) myocardial infarction I22.8 Subsequent ST elevation (STEMI) myocardial infarction of other sites I22.9 Subsequent ST elevation (STEMI) myocardial infarction of unspecified site I24.81 Acute coronary microvascular dysfunction I24.89 Other forms of acute ischemic heart disease I24.9 Acute ischemic heart disease, unspecified I47.0 Re-entry ventricular arrhythmia I47.2 Ventricular tachycardia I49.01 Ventricular fibrillation I49.02 Ventricular flutter R55 Syncope and collapse 370.2 - Messaging for MTWA (Rev. 3265, Issued: 05- 22-15, Effective: 01 -13-15, Implementation: 06- 23-15) Effective for claims with dates of service on and after January 13, 2015, MACs shall deny claims for MTWA CPT 93025 with methods of analysis other than SA without modifier - KX using the following messages: CARC 4: The procedure code is inconsistent with the modifier used or a required modifier is missing. Note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. RARC N657 This should be billed with the appropriate code for these services. Group Code: CO (Contractual Obligation) assigning financial liability to the provider MSN 15.20 - The following policies [NCD 20.30] were used when we made this decision Spanish Equivalent - 15.20 - Las siguientes polticas [NCD 20.30] fueron utilizadas cuando se tom esta decisin. 380 - Leadless Pacemakers (Rev. 3815, Issued: 07- 28-17, Effective: 01 -18-18, Implementation: 08- 29-17 - for MAC local edits; January 2, 2018 - for MCS shared edits ) Effective for dates of service on or after January 18, 2017, contractors shall cover leadless pacemakers through Coverage with Evidence Development (CED) when procedures are performed in CMS -approved CED studies. Please refer to the National Coverage Dete rminations Manual (Publication 100- 03, Section 20.8.4) for more information. 380.1 - Leadless Pacemaker Coding and Billing Requirements for Professional Claims (Rev. 3815, Issued: 07- 28-17, Effective: 01 -18-18, Implementation: 08- 29-17 - for MAC local edits; January 2, 2018 - for MCS shared edits) Effective for dates of service on or after January 18, 2017, contractors shall allow the following procedure codes on claims for leadless pacemakers: 0387T Transcatheter insertion or replacement of permanent leadless pacemaker, ventricular 0389T Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report, leadless pacemaker system. 0390T Peri -procedural device evaluation (in person) and programming of device system parameters before or after surgery, procedure or test with analysis, review and report, leadless pacemaker system. 0391T Interrogation device evaluation (in person) with analysis, review and report, includes connection, recording and disconnection per patient encounter, leadless pacemaker system. Effective for dates of service on or after January 18, 2017, contractors shall allow the following ICD -10 diagnosis codes on claims for leadless pacemakers: Z00.6 Encounter for examination for normal comparison and control in clinical research program. 380.1.1 - Leadless Pacemaker Place of Service Restrictions (Rev. 3815, Issued: 07- 28-17, Effective: 01 -18-18, Implementation: 08- 29-17 - for MAC local edits; January 2, 2018 - for MCS shared edits) Effective for dates of service on or after January 18, 2017, contractors shall only pay claims for leadless pacemakers when services are provided in one of the following places of service (POS): POS 06 Indian Health Service Provider Based Facility POS 21 Inpatient Hospital POS 22 - On Campus -Outpatient Hospital POS 26 Military Treatment Facility 380.1.2 - Leadless Pacemaker Modifier (Rev. 3815, Issued: 07- 28-17, Effective: 01 -18-18, Implementation: 08- 29-17 - for MAC local edits; January 2, 2018 - for MCS shared edits) Effective for claims with dates of service on or after January 18, 2017, modifier Q0 Investigational clinical service provided in a clinical research study that is an approved clinical research study, must also be included. 380.1.3 - Leadless Pacemaker Additional Claim Billing Information (Rev. 3815, Issued: 07- 28-17, Effective: 01 -18-18, Implementation: 08- 29-17 - for MAC local edits; January 2, 2018 - for MCS shared edits) The professional claim must also contain the 8 -digit clinical trial identifier in item 23 of the CMS -1500 form or the electronic equivalent. 380.2 - Leadless Pacemaker Claim Adjustment Reason Codes (CARC), Remittance Advice Remark Codes (RARC) and Medicare Summary Notice (MSN) Messages Applicable for Professional Claims Only (Rev. 3815, Issued: 07- 28-17, Effective: 01 -18-18, Implementation: 08- 29-17 - for MAC local edits; January 2, 2018 - for MCS shared edits) Effective for claims with dates of service on or after January 18, 2017, contractors shall deny professional claim lines for leadless pacemakers that do not contain an appropriate POS code and use the following messages: CARC 58: Treatment was deemed by the payer to have been rendered in an inappropriate or invalid place of service. Note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. 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 http://www.cms.hhs.gov/mcd/search.asp. If you do not have web access, you may contact the contractor to request a copy of the NCD. MSN 21.25: This service was denied because Medicare only covers this service in certain settings. Spanish Version: El servicio fue denegado porque Medicare solamente lo cubre en ciertas situaciones." Group Code Contractual Obligation (CO). - Effective for dates of service on or after January 18, 2017, contractors shall return claims with the procedure codes listed in 380.2 billed without modifier Q0 and use the following messages: CARC 4: The procedure code is inconsistent with the modifier used or a required modifier is missing. Note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. RARC N572: This procedure not payable unless appropriate non- payable reporting. Group Code Contractual Obligation (CO). - Effective for dates of service on or after January 18, 2017, contractors shall return claims as unprocessable with the procedure codes listed in 10117- 04.2 billed without ICD -10 Z00.6 and use the following messages: CARC 16 - Claim/service lacks information or has submission/billing error(s) which is needed for adjudication. Do not use this code for claims attachment(s)/other documentation. At least one Remark Code must be provided (may be comprised of either the N CPDP Reject Reason Code, or Remittance Advice Remark Code that is not an ALERT.) Note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. RARC M76 - Missing/incomplete/invalid diagnosis or condition. - Effective for claims with dates of service on or after January 18, 2017, contractors shall return claims as unprocessable that are billed with the Q0 modifier and do not contain the 8- digit clinical trial identifier in item 23 of the CMS -1500 form or the electronic equivalent. Use the following messages: CARC 16: Claim/service lacks information which is needed for adjudication. At least one Remark Code must be provided (may be comprised of either the NCPDP Reject Reason Code, or Remittance Advice Remark Code that is not an ALERT.)

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- Effective for dates of service on or after January 18, 2017, contractors shall return claims as unprocessable with the procedure codes listed in 10117- 04.2 billed without ICD -10 Z00.6 and use the following messages: CARC 16 - Claim/service lacks information or has submission/billing error(s) which is needed for adjudication. Do not use this code for claims attachment(s)/other documentation. At least one Remark Code must be provided (may be comprised of either the N CPDP Reject Reason Code, or Remittance Advice Remark Code that is not an ALERT.) Note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. RARC M76 - Missing/incomplete/invalid diagnosis or condition. - Effective for claims with dates of service on or after January 18, 2017, contractors shall return claims as unprocessable that are billed with the Q0 modifier and do not contain the 8- digit clinical trial identifier in item 23 of the CMS -1500 form or the electronic equivalent. Use the following messages: CARC 16: Claim/service lacks information which is needed for adjudication. At least one Remark Code must be provided (may be comprised of either the NCPDP Reject Reason Code, or Remittance Advice Remark Code that is not an ALERT.) RARC MA50: Missing/incomplete/invalid Investigational Device Exemption number or Clinical Trial number. Group Code Contractual Obligation (CO). 390 - Supervised exercise therapy (SET) Symptomatic Peripheral Artery Disease (Rev. 4049, Issued: 05- 11-18, Effective: 05 -25-17, Implementation: 07- 02-18) Effective for claims with dates of service on or after May 25, 2017, the Centers for Medicare and Medicaid Services (CMS) will cover supervised exercise therapy (SET) for beneficiaries with intermittent claudication (IC) for the treatment of symptomatic peripheral artery disease ( PAD). Up to 36 sessions over a 12 week period are covered if all of the following components of a SET program are met: The SET program must: consist of sessions lasting 30- 60 minutes comprising a therapeutic exercise -training program for PAD in patients with claudication; be conducted in a physicians office; be delivered by qualified auxiliary personnel necessary to ensure benefits exceed harms, and who are trained in exercise therapy for PAD; and be under the direct supervision of a physician (as defined in 1861(r)(1)) of the Social Security Act (the Act)), physician assistant, or nurse practitioner/clinical nurse specialist (as identified in 1861(aa)(5)) of (the Act) who must be trained in both ba sic and advanced life support techniques. Beneficiaries must have a face- to-face visit with the physician responsible for PAD treatment to obtain the referral for SET. At this visit, the beneficiary must receive information regarding cardiovascular disease and PAD risk factor reduction, which could include education, counseling, behavioral interventions, and outcome assessments. SET is non -covered for beneficiaries with absolute contraindications to exercise as determined by their primary attending physician. . Please refer to the National Coverage Determinations Manual (Publication 100 -03, Section 20.35) for more information. 390.1 General Billing Requirements (Rev. 4049, Issued: 05- 11-18, Effective: 05 -25-17, Implementation: 07- 02-18) Effective for claims with date of services on or after May 25, 2017, contractors shall pay claims for SET for beneficiaries with IC for the treatment of symptomatic PAD, with a referral from the physician responsible for PAD treatment. Medicare Administrative Contractors (MACs) have the discretion to cover SET beyond 36 sessions over 12 weeks and may cover an additional 36 sessions over an extended period of time. Contractors shall accept the inclusion of the KX modifier on the claim line(s) as an attestation by the provider of the services that documentation is on file verifying that further treatment beyond the 36 sessions of SET over a 12 week period meets the requirements of the medical policy. 390.2 Coding Requirements for SET (Rev. 4049, Issued: 05- 11-18, Effective: 05 -25-17, Implementation: 07- 02-18) CPT 93668 Under Peripheral Arterial Disease Rehabilitation ICD-10 Codes I70.211 right leg I70.212 left leg I70.213 bilateral legs I70.218 other extremity I70.311 right leg I70.312 left leg I70.313 bilateral legs I70.318 other extremity I70.611 right leg I70.612 left leg I70.613 bilateral legs I70.618 other extremity I70.711 right leg I70.712 left leg I70.713 bilateral legs I70.718 other extremity 390.3 Special Billing Requirements for Institutional Claims (Rev.4049, Issued: 05- 11-18, Effective: 05 -25-17, Implementation: 07- 02-18) Contractors shall pay claims for SET services containing CPT code 93668 on Types of Bill (TOBs) 13X under OPPS and 85X based on reasonable cost. Contractors shall pay claims for SET services containing CPT 93668 with revenue codes 096X, 097X, or 098X when billed on TOB 85X Method II based on 115% of the lesser of the fee schedule amount or the submitted charge. 390.4 Common Working File (CWF) Requirements (Rev.4049, Issued: 05- 11-18, Effective: 05 -25-17, Implementation: 07 -02-18) CWF shall create a new edit for CPT 93668 to reject claims when a beneficiary has reached 36 SET sessions within 84 days after the date of the first SET session and the KX modifier is not included on the claim or to reject any SET session provided after 84 days from the date of the first session and the KX modifier is not included on the claim. CWF shall determine the remaining SET sessions. The CWF determination, to parallel claims processing, shall include all applicable factors including: Beneficiary entitlement status Beneficiary claims history Utilization rules CWF shall update the determination when any changes occur to the beneficiary master data or claims data that would result in a change to the calculation. CWF shall display the remaining SET sessions on all CWF provider query screens. The Multi -Carrier System Desktop Tool (MCSDT) shall display the remaining SET sessions in a format equivalent to the CWF HIMR screen(s). 390.5 Applicable Medicare Summary Notice (MSN), Remittance Advice Remark Codes and Claim Adjustment Reason Code Messaging (Rev.4049, Issued: 05- 11-18, Effective: 05 -25-17, Implementation: 07- 02-18) Contractors shall deny claims for SET when services are provided on other than TOBs 13X and 85X using the following messages: MSN 15.20: The following policies NCD 20.35 were used when we made this decision. Spanish Version Las siguientes polticas NCD 20.35 fueron utilizadas cuando se tom esta decisin. (Part A only) 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-MEDICARE (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 piens a que puede cambiar nuestra decisin. Para obtener una copia del LCD, llame al 1 -800-MEDICARE (1800- 633-4227). Claim Adjustment Reason Code (CARC) 58: Treatment was deemed by the payer to have been rendered in an inappropriate or invalid place of service. NOTE: Refer to the 832 Healthcare Policy Identification Segment (loop 2110 Service payment Information REF), if present. Remittance advice remark code (RARC) N386: This decision was based on a National Coverage Determination (NCD) 20.35. 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. Contractors shall use Group Code CO (Contractual Obligation) assigning financial liability to the provider, if a claim is received with a GZ modifier indicating no signed ABN is on file. Contractors deny/reject claim lines for CPT 93668 without one of the diagnosis codes listed in 390.2 and use the following messages: MSN 15.20: The following policies NCD 20.35 were used when we made this decision. Spanish Version Las siguientes polticas NCD 20.35 fueron utilizadas cuando se tom esta decisin. (Part A only) 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-MEDICARE (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 piens a que puede cambiar nuestra decisin. Para obtener una copia del LCD, llame al 1 -800-MEDICARE (1800- 633-4227). CARC 167 This (these) diagnosis(es) is (are) not covered. Note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. 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. Contractors shall use Group Code PR (Patient Responsibility) assigning financial liability to the beneficiary if a claim is received with a GA modifier indicating a signed ABN is on file. Contractors shall use Group CO (Contractual Obligation) assigning financial liability to the provider, if a claim is received with a GZ modifier indicating no signed ABN is on file. Contractors shall reject claims with CPT 93668 which exceed 36 sessions within 84 days from the date of the first session when the KX modifier is not included on the claim line OR any SET session provided after 84 days from the date of the first session an d the KX modifier is not included on the claim and use the following messages: 96- Non -covered charge(s). At least one Remark Code must be provided (may be comprised of either the NCPDP Reject Reason [sic] Code, or Remittance Advice Remark Code that is not an ALERT.) Note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. N640 Exceeds number/frequency approved/allowed within time period. Group Code CO (Contractual Obligation) assigning financial liability to the provider (if a claim line -item is received with a GZ modifier indicating no signed ABN is on file and occurrence code 32 is not present). Contractors shall deny/reject claim lines with CPT 93668 when sessions have reached 73 sessions using the following messages: MSN 15.20: The following policies NCD 20.35 were used when we made this decision. Spanish Version Las siguientes polticas NCD 20.35 fueron utilizadas cuando se tom esta decisin. (Part A only) 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-MEDICARE (1 -800-633-4227) for a copy of the LCD.

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Note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. N640 Exceeds number/frequency approved/allowed within time period. Group Code CO (Contractual Obligation) assigning financial liability to the provider (if a claim line -item is received with a GZ modifier indicating no signed ABN is on file and occurrence code 32 is not present). Contractors shall deny/reject claim lines with CPT 93668 when sessions have reached 73 sessions using the following messages: MSN 15.20: The following policies NCD 20.35 were used when we made this decision. Spanish Version Las siguientes polticas NCD 20.35 fueron utilizadas cuando se tom esta decisin. (Part A only) 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-MEDICARE (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 piens a que puede cambiar nuestra decisin. Para obtener una copia del LCD, llame al 1 -800-MEDICARE (1800- 633-4227). CARC 119: Benefit maximum for this time period or occurrence has been reached. 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. Group Code PR (Patient Responsibility) assigning financial responsibility to the beneficiary (if a claim is received with occurrence code 32 with or without a GA modifier or a claim -line is received with a GA modifier indicating a signed ABN is on file) Group Code CO (Contractual Obligation) assigning financial liability to the provider (if a claim line -item is received with a GZ modifier indicating no signed ABN is on file and occurrence code 32 is not present Contractors shall deny claim line -items for SET, CPT 93668, when sessions have reached 73 sessions with or without the KX Modifier present using the following messages: MSN 15.20: The following policies NCD 20.35 were used when we made this decision. Spanish Version Las siguientes polticas NCD 20.35 fueron utilizadas cuando se tom esta decisin. (Part A only) 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- MEDICARE (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 (1800-633-4227). CARC 119: Benefit maximum for this time period or occurrence has been reached. 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. Group Code PR (Patient Responsibility) assigning financial responsibility to the beneficiary (if a claim is received with occurrence code 32 with or without a GA modifier or a claim -line is received with a GA modifier indicating a signed ABN is on file) Group Code CO (Contractual Obligation) assigning financial liability to the provider (if a claim line- item is received with a GZ modifier indicating no signed ABN is on file and occurrence code 32 is not present). 400 - Chimeric Antigen Receptor (CAR) T -cell Therapy (Rev. 11721; Issued: 11-28-22; Effective: 01 -01-23; Implementation: 01-03-23) T-cells employ a number of mechanisms to fight abnormal cells such as cancer. One type of therapy that leverages the immune system, immunotherapy, is Chimeric Antigen Receptor (CAR) T-cell therapy. CAR T- cells have been genetically altered in order to impr ove the ability of the T- cells to fight cancer. 400.1 - Coverage Requirements (Rev. 11721; Issued: 11-28-22; Effective: 01 -01-23; Implementation: 01-03-23) Effective for services performed on or after August 7, 2019, the Centers for Medicare & Medicaid Services (CMS) covers autologous treatment for cancer with T- cells expressing at least one CAR when administered at healthcare facilities enrolled in the Food and Drug Administration (FDA) risk evaluation and mitigation strategies (REMS) and used for a medically accepted indication as defined at Social Security Act (the Act) section 1861(t)(2), i.e., is used for either an FDA -approved indication (according to the FDA-approved label for that product), or for other uses when the product has been FDA-approved and the use is supported in one or more CMS-approved compendia. See Publication 100-03, National Coverage Determination (NCD) Manual 110.24 for complete coverage criteria. See the following websites for specific REMS facility information: Kymriah https://www.us.kymriah.com/treatment- center -locator Yescarta https://www.yescarta.com/find -a-treatment -center Tecartus https://www.tecartus.com/hcp/treatment- center -locator Breyanzi https://www.celltherapy360.com/locations ABECMA https://www.celltherapy360.com/locations CARVYKTI https://www.carvyktihcp.com/treatment- centers NOTE: The use of allogenic T-cells from healthy donors are not autologous CAR T- cell treatments and shall not be billed as autologous CAR T- cell treatments. 400.2 - Billing Requirements (Rev. 11721; Issued: 11- 28-22; Effective: 01 -01-23; Implementation: 01 -03-23) Effective for dates of service on or after August 7, 2019, contractors shall pay for line -item professional claims from approved providers for the administration of autologous treatment for cancer with T -cells expressing at least one CAR with Current Proce dural Terminology (CPT) code 0540T. Contractors shall not require the NCD 110.24 - KX modifier and diagnosis codes for clinical trials under NCD 310.1. These claims shall be billed with the NCT number for the specific trial, the -Q0 clinical trial modifier, and the Z00.6 clinical trial diagno sis code on the 0540T claim line effective for dates of service on or after August 7, 2019. For Part A Outpatient (OPPS) contractors shall not require NCD 110.24 REMS facility and diagnosis codes for CAR T -cell therapy CPT code 0540T in clinical trials under NCD 310.1 billed with the NCT number for the specific trial, the -Q0 clinical trial modifier, condition code 30, value code D4, and the Z00.6 clinical trial diagnosis code effective for dates of service on or after August 7, 2019. 400.2.1 - A/B Medicare Administrative Contractor (MAC) (A) Bill Types (Rev. 10891, Issued: 07- 20-21, Effective: 08 -07-19, Implementation: 09- 20-21) Valid type of bills (TOBs) for billing inpatient CAR T -cell therapy services may include (but are not necessarily limited to): 011x Inpatient Hospital 012x Inpatient Ancillary Hospital Valid TOBs for billing outpatient CAR T -cell therapy services may include (but are not necessarily limited to): 013x Outpatient Hospital 085x Critical Access Hospital 400.2.2 - A/B MAC (A) Revenue Code (Rev. 11721; Issued: 11- 28-22; Effective: 01 -01-23; Implementation: 01 -03-23) The following Revenue Codes are used for billing inpatient and outpatient CAR T -cell therapy services: 0871 Cell Collection w/CPT code 0537T 0872 Specialized Biologic Processing and Storage Prior to Transport w/CPT code 0538T 0873 Storage and Processing after Receipt of Cells from Manufacturer w/CPT code 0539T 0874 Infusion of Modified Cells w/CPT code 0540T 0891 Special Processed Drugs FDA Approved Cell Therapy w/ Healthcare Common Procedure Coding System (HCPCS) codes Q2041, Q2042, C9073 (replaced with Q2053 April 1, 2021), C9076 (replaced with Q2054 October 1, 2021), C9081 (replaced with Q2055 January 1, 2022), C9098 (replaced with Q2056 October 1, 2022), or C9399 400.2.3 - A/B MAC Billing HCPCS Codes (Rev. 11721; Issued: 11- 28-22; Effective: 01 -01-23; Implementation: 01 -03-23) The following HCPCS/CPT procedure codes are used for billing outpatient CAR T -cell therapy services: HCPCS Code Q2041 for Axicabtagene Ciloleucel HCPCS Code Q2042 for Tisagenlecleucel HCPCS Code Q2053 for Brexucabtagene Autoleucel (effective April 1, 2021) HCPCS Code Q2054 for Lisocabtagene Maraleucel (effective October 1, 2021) HCPCS Code Q2055 for Idecabtagene Vicleucel (effective January 1, 2022) HCPCS Code Q2056 for Ciltacabtagene Autoleucel (effective October 1, 2022) HCPCS Code C9073 for Brexucabtagene Autoleucel (prior to April 1, 2021) HCPCS Code C9076 for Lisocabtagene maraleucel (prior to October 1, 2021) HCPCS Code C9081 for Idecabtagene Vicleucel (prior to January 1, 2022) HCPCS Code C9098 for Ciltacabtagene Autoleucel (prior to October 1, 2022) HCPCS Code C9399, J3490, J3590, or J9999 for unclassified drugs or biologicals when dose of CAR T -cell therapy exceeds code descriptor or when other CAR T -cell therapy obtains FDA approval but has not yet received a specific HCPCS code CPT Code 0537T collection/handling* CPT Code 0538T preparation for transport* CPT Code 0539T receipt and preparation* CPT Code 0540T the provider (physician/NPP) procedure to administer CAR T -cells * Procedure represents the various steps required to collect and prepare the genetically modified T -cells, and these steps are not paid separately under the Outpatient Prospective Payment System (OPPS)/Medicare Physician Fee Schedule (MPFS). 400.2.3.1 A/B MAC (B) Places of Service (POS) (Rev. 11721; Issued: 11- 28-22; Effective: 01 -01-23; Implementation: 01 -03-23) The following places of service (POS) are covered for CAR T -cells product HCPCS codes (Q2041, Q2042, Q2053-Q2056, J3490, J3590, and J9999): 11 (Office) 49 (Independent clinic) Professional claims for the procedure to administer CAR T -cells (0540T) may include (but are not necessarily limited to): 11 (Office) 19 (Off Campus -Outpatient Hospital) 21 (Inpatient Hospital) 22 (On Campus -Outpatient Hospital) 49 (Independent Clinic)

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* Procedure represents the various steps required to collect and prepare the genetically modified T -cells, and these steps are not paid separately under the Outpatient Prospective Payment System (OPPS)/Medicare Physician Fee Schedule (MPFS). 400.2.3.1 A/B MAC (B) Places of Service (POS) (Rev. 11721; Issued: 11- 28-22; Effective: 01 -01-23; Implementation: 01 -03-23) The following places of service (POS) are covered for CAR T -cells product HCPCS codes (Q2041, Q2042, Q2053-Q2056, J3490, J3590, and J9999): 11 (Office) 49 (Independent clinic) Professional claims for the procedure to administer CAR T -cells (0540T) may include (but are not necessarily limited to): 11 (Office) 19 (Off Campus -Outpatient Hospital) 21 (Inpatient Hospital) 22 (On Campus -Outpatient Hospital) 49 (Independent Clinic) 400.2.4 - A/B MAC Diagnosis and Procedure Code Requirements (Rev. 11721; Issued: 11- 28-22; Effective: 01 -01-23; Implementation: 01 -03-23) Please see NCD spreadsheet for the applicable International Classification of Disease (ICD) -10-CM diagnosis codes for CAR T -cell therapy coverage. The following are the applicable ICD -10-PCS procedure codes for CAR T -cell therapy coverage for inpatient claims: For dates of service on or after October 1, 2021: CARVYKTI - XW033A7: Introduction of Ciltacabtagene Autoleucel into Peripheral Vein, Percutaneous Approach, New Technology Group 7 CARVYKTI - XW043A7: Introduction of Ciltacabtagene Autoleucel into Central Vein, Percutaneous Approach, New Technology Group 7 When other CAR T -cell therapy obtains FDA approval but has not yet received a specific PCS code, and for use in clinical trials FDA -approved under NCD 310.1 XW033C7: Introduction of Autologous Engineered Chimeric Antigen Receptor T -cell Immunotherapy int o Peripheral Vein, Percutaneous Approach, New Technology Group 7 When other CAR T -cell therapy obtains FDA approval but has not yet received a specific PCS code, and for use in clinical trials FDA -approved under NCD 310.1 XW043C7: Introduction of Autologous Engineered Chimeric Antigen Receptor T -cell Immunotherapy int o Central Vein, Percutaneous Approach, New Technology Group 7 Yescarta - XW033H7: Introduction of Axicabtagene Ciloleucel Immunotherapy into Peripheral Vein, Percutaneous Approach, New Technology Group 7 Yescarta - XW043H7: Introduction of Axicabtagene Ciloleucel Immunotherapy into Central Vein, Percutaneous Approach, New Technology Group 7 Kymriah - XW033J7: Introduction of Tisagenlecleucel Immunotherapy into Peripheral Vein, Percutaneous Approach, New Technology Group 7 Kymriah - XW043J7: Introduction of Tisagenlecleucel Immunotherapy into Central Vein, Percutaneous Approach, New Technology Group 7 ABECMA - XW033K7: Introduction of Idecabtagene Vicleucel Immunotherapy into Peripheral Vein, Percutaneous Approach, New Technology Group 7 ABECMA - XW043K7: Introduction of Idecabtagene Vicleucel Immunotherapy into Central Vein, Percutaneous Approach, New Technology Group 7 Tecartus - XW033M7: Introduction of Brexucabtagene Autoleucel Immunotherapy into Peripheral Vein, Percutaneous Approach, New Technology Group 7 Tecartus - XW043M7: Introduction of Brexucabtagene Autoleucel Immunotherapy into Central Vein, Percutaneous Approach, New Technology Group 7 Breyanzi - XW033N7: Introduction of Lisocabtagene Maraleucel Immunotherapy into Peripheral Vein, Percutaneous Approach, New Technology Group 7 Breyanzi - XW043N7: Introduction of Lisocabtagene Maraleucel Immunotherapy into Central Vein, Percutaneous Approach, New Technology Group 7 For dates of service prior to October 1, 2021: Yescarta, ABECMA, Kymriah - XW033C3: Introduction of Engineered Autologous Chimeric Antigen Receptor T -cell Immunotherapy into Peripheral Vein, Percutaneous Approach, New Technology Group 3 Yescarta, ABECMA, Kymriah - XW043C3: Introduction of Engineered Autologous Chimeric Antigen Receptor T -cell Immunotherapy into Central Vein, Percutaneous Approach, New Technology Group 3 Tecartus - XW23346 - Transfusion of Brexucabtagene Autoleucel Immunotherapy into Peripheral Vein, Percutaneous Approach, New Technology Group 6 Tecartus - XW24346 - Transfusion of Brexucabtagene Autoleucel Immunotherapy into Central Vein, Percutaneous Approach, New Technology Group 6 Breyanzi - XW23376 Transfusion of lisocabtagene maraleucel immunotherapy into peripheral vein, percutaneous approach, new technology group 6 Breyanzi - XW24376 Transfusion of lisocabtagene maraleucel immunotherapy into central vein, percutaneous approach, new technology 6 NOTE: Since allogenic T -cells are by definition not autologous CAR T -cells, it is inappropriate to use any of the above autologous CAR T -cell ICD -10 PCS procedure codes for allogenic T -cell treatments. For Part A Inpatient contractors shall not require NCD 110.24 REMS facility and diagnosis codes for autologous CAR T-cell therapy ICD -10-PCS codes XW033A7/XW043A7, XW033H7/XW043H7, XW033J7/XW043J7, XW033K7/XW043K7, XW033M7/XW043M7, and XW033N7/XW043N7 in c linical trials under NCD 310.1 billed with the NCT number for the specific trial, condition code 30, value code D4, and the Z00.6 clinical trial diagnosis code effective for dates of service on or after August 7, 2019. 400.2.5 Billing Information for Professional Claims (Rev. 11721; Issued: 11- 28-22; Effective: 01 -01-23; Implementation: 01 -03-23) Professional claims for CAR T -cell therapy and related services are billed using the Form CMS -1500 or 837P following instructions in chapter 12 of this manual (www.cms.hhs.gov/manuals/104_claims/clm104index.asp). Contractors shall pay professional claims for CAR T -cell therapy when the service is administered at a healthcare facility that is enrolled in the REMS program as a REMS participating site. Contractors shall use the CMS HCPCS Website for current HCPCS codes, https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/HCPCS -Quarterly -Update, and the individual REMS facility websites noted at section 400.1. Contractors shall create an edit that only allows CAR T -cell therapy services to be submitted by, or performed in, an FDA REMS approved facility when the line item has a - KX modifier appended. Note: When a provider submits a - KX modifier on CAR T -cell therapy services, they are acknowledging that the service is being submitted by or performed in an FDA REMS approved facility. Contractors shall create an edit that only allows CAR T -cell therapy services when the line item has a - LU modifier appended in addition to a - KX modifier. Note: When a provider submits an - LU modifier on a CAR T -cell claim, it informs the MAC that the service is fractionated. The total units shall not exceed 1 unit. Contractors shall set up their systems to allow fractionated units on multiple claims for CAR T -cell products on the same DOS. These claims should suspend for proper adjudication of payment. The total payment will be divided by 10 and the provider will need to bill in 0.1 unit fractions. The provider will need to bill a total of 10 fractional units to reach the total Medicare allowed payment amount. Example: CAR T -cell product allowed payment $445,000: 0.2 units = $89,000.06 0.2 units = $89,000.00 0.2 units = $88,999.99 0.2 units = $88,999.98 0.2 units = $88,999.97 Note: Contractors shall only pay up to 1 unit, anything exceeding 1 unit must be denied. For CAR T -cell products when the dose exceeds the code descriptor, use HCPCS code J3490, J3590, or J9999 for the exceeded dosage. Include the CAR T -cell product name and the exceeded dosage in Block 19 of the 1500 claim form or its electronic equivalent. Example: CAR T -cell product with dose exceeded allowed payment $150,000: 0.5 units = $74,999.00 0.5 units = $75,001.00 For CAR T -cell products when the dose exceeds the code descriptor, the provider would bill a total of 1 unit of the Q code plus a total of 1 unit of the J code. For example, Q2041 Axicabtagene ciloleucel, up to 200 million autologous anti-CD19 CAR positive T- cells. If the provider gives 300 million cells, they will bill: Q2041 for 0.1 fraction $42,294.00 x10 for 200 million cells (total $422,940.00) J9999 for 0.2 fractions $42,294.00 x5 for 100 million cells (total $211,470.00) NOTE: The FDA labels for CAR T -cell products state the maximum number of cells that are to be infused. The HCPCS code descriptors for Q2041, Q2042, Q2053, Q2054, Q2055, and Q2056 all align with the FDA label maximum number of cells that are to be infused. If a provider exceeds the HCPCS code descriptor number of cells, this is off label use. This should be extremely rare. Contractors shall allow a -76 modifier (repeat procedure or service by same physician or other qualified healthcare professional) on subsequent claims billed on the same date of service to assist with preventing duplicate denials. 400.3 - Payment Requirements (Rev. 10891, Issued: 07-20-21, Effective: 08-07-19, Implementation: 09-20-21) Inpatient The A/ B MAC billing requirements will allow for CAR T -cell therapy when the services are submitted on the following TOB: 11X. Type of facility and setting determines the basis of payment: For services performed in inpatient hospitals, TOB 11X, under the Inpatient PPS is based on the Medicare Severity -Diagnosis Related Group (MS- DRG). For services performed in Critical Access Hospital (CAH) inpatient TOB 11X, payment is based on 101% of reasonable cost. Outpatient The A/B MAC billing requirements will pay for CAR T -cell therapy when the services are submitted on the TOBs: 13X and 85x. Type of facility and setting determines the basis of payment: For services performed in hospital outpatient departments (HOPDs), TOBs 13X, or inpatient ancillary TOB 12X, payment is based on OPPS. For services performed in CAH OPDs, TOB 85X, payment is based on reasonable cost. For services performed in CAH Method II with revenue code 096X, 097X, and 098X, TOB 85X, payment is based on the lesser of the actual charge or the Medicare Physician Fee Schedule (115% of the lesser of the fee schedule amount and submitted charge).

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Inpatient The A/ B MAC billing requirements will allow for CAR T -cell therapy when the services are submitted on the following TOB: 11X. Type of facility and setting determines the basis of payment: For services performed in inpatient hospitals, TOB 11X, under the Inpatient PPS is based on the Medicare Severity -Diagnosis Related Group (MS- DRG). For services performed in Critical Access Hospital (CAH) inpatient TOB 11X, payment is based on 101% of reasonable cost. Outpatient The A/B MAC billing requirements will pay for CAR T -cell therapy when the services are submitted on the TOBs: 13X and 85x. Type of facility and setting determines the basis of payment: For services performed in hospital outpatient departments (HOPDs), TOBs 13X, or inpatient ancillary TOB 12X, payment is based on OPPS. For services performed in CAH OPDs, TOB 85X, payment is based on reasonable cost. For services performed in CAH Method II with revenue code 096X, 097X, and 098X, TOB 85X, payment is based on the lesser of the actual charge or the Medicare Physician Fee Schedule (115% of the lesser of the fee schedule amount and submitted charge). HOPDs may report CPT codes 0537T, 0538T, and 0539T to allow tracking of these services when furnished in the outpatient setting. Medicare will reject these lines as Medicare does not separately pay for these services under the OPPS. These following scenarios present further clarification on how to report items and services related to CAR -T in various clinical scenarios. Scenario 1: CAR -T Dosing and Preparation Services and Viable T -cells Administered in HOPDs : In instances when you administer the CAR -T drug in the HOPD setting, report CPT code 0540T for the administration and HCPCS Q2041, Q2042, Q2053 (effective April 1, 2021), C9073 (prior to April 1, 2021), C9076, or, if a more specific code is unavailable, the most appropriate unclassified drug code (e.g., C9399 for unclassified drugs or biologicals). NOTE : the drug codes will be denied as a Part A service even if billed with the administration.) For specific instructions on billing unclassified drug codes, refer to Chapter 26, Section 10.4 of the Medicare Claims Processing Manual on the CMS website at: R egulations -and-Guidance.Ch26. As discussed in the Calendar Year (CY) 2019 OPPS/Ambulatory Surgery Center final rule (83 FR 58904), the procedures described by CPT 0537T (collection/handling), 0538T (preparation for transport), and 0539T (receipt and prepar ation) represent the various steps required to collect and prepare the genetically modified T -cells, and these steps are not paid separately under the OPPS. However, you may report the charges for these various steps to collect and prepare the CAR T -cells separately and Medicare will reject them on the HOPD claim, or they may be included in the charge reported for the biological. Note : When including the charges for collection and preparation of the CAR T -cells in the charge for the CAR -T product, outpatient providers should code the CAR -T product service on the date that the CAR -T administration took place and not on the date when the cells were collected. Scenario 2: CAR -T Dosing and Preparation Services Administered in HOPD Setting, but Viable T -cells Not Administered: In instances when the CAR -T drug is not ultimately administered to the beneficiary, but the CAR -T preparation services are initiated or performed in the HOPD facility, the hospital may not report the drug Q code (which only applies when the T -cells are adm inistered in the HOPD setting). HOPDs may report CPT 0537T, 0538T, and 0539T (as appropriate) and the charges associated with each code under the appropriate revenue code on the HOPD claim. Medicare will reject these codes. Scenario 3: CAR -T Dosing and Preparation Services Administered in HOPD Setting, but Viable T -cells Administered in the Hospital Inpatient Setting: When CAR T -cell preparation services are initiated and furnished in the HOPD setting, but the CAR T -cells are administered in the inpatient setting, the hospital may not report the drug Q code (which only applies when the T -cells are administered in the HO PD setting). Report the charge associated with the various steps to collect and prepare the CAR T -cells on the inpatient claim (TOB 11x) separately using revenue codes 0871, 0872, or 0873. Alternatively, the hospital may include the charges for these various steps in the charge reported for the biological using revenue code 0891 Special Processed Drugs FDA (U.S. Food and Drug Administration) Approved Cell Therapy Charges for Modified cell therapy. Note : When the cells are collected in the HOPD setting and the CAR -T is administered in the hospital inpatient setting, inpatient providers should report the date that the CAR-T administration took place and not the date the cells were collected. Physician Office or Non -Hospital Clinic The A/B MAC billing requirements will pay for CAR T -cell therapy when the services are submitted on the Form CMS -1500 or electronic 837P. Scenario 1: CAR -T Dosing and Preparation Services and Viable T- cells Administered in Physician Office or Non -Hospital Clinic : In instances when you administer the CAR-T drug in the physician office setting or other non- hospital clinic setting that is enrolled in the REMS program as a REMS participating site, report CPT code 0540T for the administration and HCPCS Q2041, Q2042, Q2053 (effective April 1, 2021), C9073 (prior to April 1, 2021), C9076, or, if a more specific code is unavailable, the most appropriate unclassified drug code (e.g., J3590 for unclassified biologics). For specific instructions on billing unclassified drug codes, refer to Chapter 26, Section 10.4 of the Medicare Claims Processing Manual on the CMS website at: Regulations- and-Guidance.Ch26. The procedures described by CPT 0537T (collection/handling), 0538T (preparation for transport), and 0539T (receipt and preparation) represent the various steps required to collect and prepare the genetically modified T- cells, and these steps are not paid separately under the MPFS. However, you may report them separately, and Medicare will reject them on the professional claim. Note : Practitioners should code the CAR- T product service on the date that the CAR -T administration took place and not on the date when the cells were collected. Scenario 2: CAR -T Dosing and Preparation Services Administered in Physician Office or Non -Hospital Clinic, but Viable T -cells Not Administered: In instances when the CAR -T drug is not ultimately administered to the beneficiary, but the CAR- T preparation services are initiated or performed in the physician office or other non- hospital clinic facility, the practitioner may not report the drug HCPCS code (which only applies when the T- cells are administered in the setting). The practitioner may report CPT 0537T, 0538T, and 05(Rev. 11721; Issued: 11-28-22; Effective: 01 -01-23; Implementation: 01-03-23) Inpatient The A/ B MAC billing requirements will allow for CAR T -cell therapy when the services are submitted on the following TOB: 11X. Type of facility and setting determines the basis of payment: For services performed in inpatient hospitals, TOB 11X, under the Inpatient PPS is based on the Medicare Severity-Diagnosis Related Group (MS- DRG). For services performed in Critical Access Hospital (CAH) inpatient TOB 11X, payment is based on 101% of reasonable cost. Outpatient The A/B MAC billing requirements will pay for CAR T -cell therapy when the services are submitted on the TOBs: 13X and 85x. Type of facility and setting determines the basis of payment: For services performed in hospital outpatient departments (HOPDs), TOBs 13X, or inpatient ancillary TOB 12X, payment is based on OPPS. For services performed in CAH OPDs, TOB 85X, payment is based on reasonable cost. For services performed in CAH Method II with revenue code 096X, 097X, and 098X, TOB 85X, payment is based on the lesser of the actual charge or the Medicare Physician Fee Schedule (115% of the lesser of the fee schedule amount and submitted charge). HOPDs may report CPT codes 0537T, 0538T, and 0539T to allow tracking of these services when furnished in the outpatient setting. Medicare will reject these lines as Medicare does not separately pay for these services under the OPPS. These following scenarios present further clarification on how to report items and services related to CAR T -cells in various clinical scenarios. Scenario 1: CAR T -cell Dosing and Preparation Services and Viable T -cells Administered in HOPDs: In instances when a physician or non- physician provider administers the CAR T -cell product in the HOPD setting, report CPT code 0540T for the administration. The HOPD reports CAR T -cell product HCPCS code Q2041, Q2042, Q2053 (effective April 1, 2021), C9073 (prior to April 1, 2021), Q2054 (effective October 1, 2021), C9076 (prior to October 1, 2021), Q2055 (effective January 1, 2022), C9081 (prior to January 1, 2022), Q2056 (effective October 1, 2022), C9098 (prior to October 1, 2022), or, if a more specif ic code is unavailable, the most appropriate unclassified drug code (e.g., C9399 for unclassified drugs or biologicals). For specific instructions on billing unclassified drug codes, refer to Chapter 26, Section 10.4 of the Medicare Claims Processing Manual on the CMS website at: Regulations -and-Guidance.Ch26. As discussed in the Calendar Year (CY) 2019 OPPS/Ambulatory Surgery Center final rule (83 FR 58904), the procedures described by CPT codes 0537T (collection/handling), 0538T (preparation for transport), and 0539T (receipt and preparation) represent the var ious steps required to collect and prepare the genetically modified T -cells, and these steps are not paid separately under the OPPS. However, you may report the charges for these various steps to collect and prepare the CAR T -cells separately and Medicare will reject them on the HOPD claim, or they may be included in the charge reported for the biological. Note: When including the charges for collection and preparation of the CAR T -cells in the charge for the CAR T -cell product, outpatient providers should code the CAR T -cell product service on the date that the CAR T -cell administration took place and not on the date when the cells were collected. Scenario 2: CAR T -cell Dosing and Preparation Services in HOPD Setting, but Viable T -cells Not Administered: In instances when the CAR T -cell product is not ultimately administered to the beneficiary, but the CAR T -cell preparation services are initiated or performed in the HOPD facility, the hospital shall not report the CAR T -cell product HCPCS code (which only applies when viable T -cells are administered). HOPDs may report CPT codes 0537T, 0538T, and 0539T (as appropriate) and the charges associated with each code under the appropriate revenue code on the HOPD claim. Medicare will reject these codes. Scenario 3: CAR T -cell Dosing and Preparation Services in HOPD Setting, but Viable T -cells Administered in the Hospital Inpatient Setting: When CAR T -cell preparation services are initiated and furnished in the HOPD setting, but the CAR T -cells are administered in the inpatient setting, the hospital shall not report the CAR T -cell product HCPCS code (which only applies when viable T -cells are administered in the outpatient setting). Report the charge associated with the various steps to collect and prepare the CAR T -cells on the inpatient claim (TOB 11x) separately using revenue codes 0871, 0872, or 0873. Alternatively, the hospital may include the charges for these various steps in the charge reported for the biological using revenue code 0891 Special Processed Drugs FDA (U.S. Food and Drug Administration) Approved Cell Therapy Charges for Modified cell therapy.

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Scenario 3: CAR T -cell Dosing and Preparation Services in HOPD Setting, but Viable T -cells Administered in the Hospital Inpatient Setting: When CAR T -cell preparation services are initiated and furnished in the HOPD setting, but the CAR T -cells are administered in the inpatient setting, the hospital shall not report the CAR T -cell product HCPCS code (which only applies when viable T -cells are administered in the outpatient setting). Report the charge associated with the various steps to collect and prepare the CAR T -cells on the inpatient claim (TOB 11x) separately using revenue codes 0871, 0872, or 0873. Alternatively, the hospital may include the charges for these various steps in the charge reported for the biological using revenue code 0891 Special Processed Drugs FDA (U.S. Food and Drug Administration) Approved Cell Therapy Charges for Modified cell therapy. Note: When the cells are collected in the HOPD setting and the CAR T -cell product is administered in the hospital inpatient setting, inpatient providers shall report the date that the CAR T -cell administration took place and not the date the cells were collected. Physician Office or Non -Hospital Clinic The A/B MAC billing requirements will pay for CAR T -cell therapy products when the services are submitted in places of service 11 or 49. Proper adjudication of payment is based on fractionated units. The A/B MAC billing requirements will pay for CAR T -cell therapy when the services are submitted on the Form CMS -1500 or electronic 837P. Scenario 1: CAR T -cell Dosing and Preparation Services and Viable T -cells Administered in Physician Office or Non-Hospital Clinic: In instances when a physician or non-physician provider administers the CAR T-cells product in the physician office setting or other non- hospital clinic setting that is enrolled in the REMS program as a REMS participating site, report CPT code 0540T for the administration and CAR T-cell product HCPCS code Q2041, Q2042, Q2053 (effective April 1, 2021), Q2054 (effective October 1, 2021), Q2055 (effective January 1, 2022), Q2056 (effective October 1, 2022), or, if a more specific code is unavailable, the most appropriate unclassified drug code (e.g., J3590 for unclassified biologics). For specific instructions on billing unclassified drug codes, refer to Chapter 26, Section 10.4 of the Medicare Claims Processing Manual on the CMS website at: Regulations- and-Guidance.Ch26. The procedures described by CPT codes 0537T (collection/handling), 0538T (preparation for transport), and 0539T (receipt and preparation) represent the various steps required to collect and prepare the genetically modified T- cells, and these steps are not paid separately under the MPFS. However, you may report them separately, and Medicare will deny them on the professional claim as Medicare does not pay separately for this service. Note: Practitioners shall code the CAR T -cell product service on the date that the CAR T -cells administration took place and not on the date when the cells were collected. Scenario 2: CAR T -cells Dosing and Preparation Services in Physician Office or Non -Hospital Clinic, but Viable T-cells Not Administered: In instances when the CAR T -cell product is not ultimately administered to the beneficiary, but the CAR T- cells preparation services are initiated or performed in the physician office or other non- hospital clinic facility, the practitioner shall not report the CAR T -cell product HCPCS code (which only applies when viable T- cells are administered). The practitioner may report CPT codes 0537T, 0538T, and 0539T (as appropriate) on the professional claim. Medicare will deny these codes as Medicare does not pay separately for this service. Scenario 3: CAR T -cells Dosing and Preparation Services in Physician Office or Non -Hospital Clinic, but Viable T-cells Administered in the Hospital Inpatient Setting: When CAR T -cell preparation services are initiated and furnished in the physician office or other non- hospital clinic setting, but the CAR T- cells are administered in the hospital inpatient setting, the practitioner shall not report the CAR T-cells product HCPCS code (which only applies when viable T- cells are administered in the outpatient setting). The hospital that administers the T -cells will report the charge associated with the various steps to collect and prepare the CAR T -cells on the inpatient claim (TOB 11x) separately using revenue codes 0871, 0872, or 0873. Alternatively, the hospital may include the charges for these various steps in the charge reported for the biological using revenue code 0891 Special Process ed Drugs FDA (U.S. Food and Drug Administration) Approved Cell Therapy Charges for Modified cell therapy. Note: When the cells are collected in the physician office setting and the CAR T -cell product is administered in the hospital inpatient setting, inpatient providers shall report the date that the CAR T -cell administration took place and not the date the cells w ere collected. Scenario 4: CAR T -cells Dosing and Preparation Services in Physician Office or Non -Hospital Clinic, but Viable T-cells Administered in the HOPD Setting: When CAR T -cell preparation services are initiated and furnished in the physician office or other non- hospital clinic setting, but the CAR T -cells are administered in the HOPD setting, the practitioner shall not report the CAR T -cell product HCPCS code (which only applies when the viable T -cells are administered). The HOPD that administers the T -cells may report CPT codes 0537T, 0538T, and 0539T (as appropriate) and the charges associated with each code under the appropriate revenue code on the HOPD claim. Medicare will reject these codes. Note: When the cells are collected in the physician office setting and the CAR T -cell product is administered in the HOPD setting, HOPD providers shall report the date that the CAR T -cell administration took place and not the date the cells were collected. 39T (as appropriate) on the professional claim. Medicare will reject these codes. Scenario 3: CAR -T Dosing and Preparation Services Administered in Physician Office or Non -Hospital Clinic, but Viable T -cells Administered in the Hospital Inpatient Setting: When CAR T -cell preparation services are initiated and furnished in the physician office or other non- hospital clinic setting, but the CAR T -cells are administered in the inpatient setting, the practitioner may not report the drug HCPCS code (which only applies when the T -cells are administered in the setting). The hospital that administers the T -cells will report the charge associated with the various steps to collect and prepare the CAR T -cells on the inpatient claim (TOB 11x) separately using revenue cod es 0871, 0872, or 0873. Alternatively, the hospital may include the charges for these various steps in the charge reported for the biological using revenue code 0891 Special Processed Drugs FDA (U.S. Food and Drug Administration) Approved Cell Therapy Charges for Modified cell therapy. Note : When the cells are collected in the physician office setting and the CAR -T is administered in the hospital inpatient setting, inpatient providers should report the date that the CAR -T administration took place and not the date the cells were collected. 400.4 - Claim Adjustment Reason Codes (CARCs), Remittance Advice Remark Codes (RARCs), Group Codes, and Medicare Summary Notice (MSN) Messages (Rev. 11721; Issued: 11- 28-22; Effective: 01 -01-23; Implementation: 01 -03-23) Contractors shall continue to use the appropriate existing messages that they have in place when denying claims submitted that do not meet the Medicare coverage criteria for CAR T -cell therapy. --Contractors shall deny claims for CAR T -cell therapy when the service is not administered through healthcare facilities that are enrolled in the FDA REMS requirements using the following messages: CARC 58 Treatment was deemed by the payer to have been rendered in an inappropriate or invalid place of service. Usage: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. 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. Group Code CO (Contractual Obligations). MSN 16.2 This service cannot be paid when provided in this location/facility. Spanish Version Este servicio no se puede pagar cuando es suministrado en esta sitio/facilidad. In addition to the codes listed above, contractors shall afford appeal rights to all denied parties. --When denying claims for covered CAR T -cell therapy procedures because the appropriate ICD -10 coding was not used, use the following messages: CARC 50 - These are non -covered services because this is not deemed a "medical necessity" by the payer. Usage: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. 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. Group Code CO or PR dependent upon liability. MSN 15.20 - The following polices were used when we made this decision: NCD 110.24. Spanish Version Las siguientes polticas fueron utilizadas cuando se tom esta decisin: NCD 110.24. --When denying claims for covered CAR T -cell therapy procedures because they are not performed in POS 11 or 49, use the following messages: CARC 58 Treatment was deemed by the payer to have been rendered in an inappropriate or invalid place of service. Usage: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. 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. Group Code CO or PR (Patient Responsibility) dependent upon liability. (Use PR when the GA modifier is appended to the line item). MSN 09.040 - This item or service was denied because information required to make payment was incorrect. MSN 15.20 - The following polices were used when we made this decision: NCD 110.24. Spanish Version Las siguientes polticas fueron utilizadas cuando se tom esta decisin: NCD 110.24. --When denying claims for covered CAR T -cell therapy procedures because they do not contain new modifier -LU, use the following messages: CARC 4 - The procedure code is inconsistent with the modifier used. Usage: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. 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. Group Code CO MSN 15.20 - The following polices were used when we made this decision: NCD 110.24. Spanish Version Las siguientes polticas fueron utilizadas cuando se tom esta decisin: NCD 110.24. --When denying claims for covered CAR T -cell therapy procedures because the fractional units exceed 1 unit, use the following messages: CARC 151 - Payment adjusted because the payer deems the information submitted does not support this many/frequency of services. Group Code CO MSN 15.060 - The information provided does not support the need for this many services or items within this period of time. Spanish Version - (La informacin proporcionada no confirma la necesidad de estos servicios o artculos en este periodo de tiempo.) -- Contractors shall reject claims for allogeneic CAR T -cell therapy ICD -10-PCS codes XW033G7 and XW043G7 and autologous CAR T -cell therapy ICD -10-PCS codes XW033C7 and XW043C7 when not billed for clinical trials under NCD 310.1 with the NCT number for the specific trial, condition code 30, value code D4, and the Z00.6 clinical trial diagnosis code effective for dates of service on or after October 1, 2021, using the following messages:

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Group Code CO MSN 15.060 - The information provided does not support the need for this many services or items within this period of time. Spanish Version - (La informacin proporcionada no confirma la necesidad de estos servicios o artculos en este periodo de tiempo.) -- Contractors shall reject claims for allogeneic CAR T -cell therapy ICD -10-PCS codes XW033G7 and XW043G7 and autologous CAR T -cell therapy ICD -10-PCS codes XW033C7 and XW043C7 when not billed for clinical trials under NCD 310.1 with the NCT number for the specific trial, condition code 30, value code D4, and the Z00.6 clinical trial diagnosis code effective for dates of service on or after October 1, 2021, using the following messages: CARC 55: Procedure/treatment/drug is deemed experimental/investigational by the payor. Group Code: CO MSN 16.77 This service/item was not covered because it was not provided as part of a qualifying trial/study. Spanish Version (Este servicio/artculo no fue cubierto porque no estaba incluido como parte de un ensayo clnico/estudio calificado.) In addition to the codes listed above, contractors shall afford appeal rights to all denied parties. 400.5 - Claims Editing (Rev. 11721; Issued: 11-28-22; Effective: 01 -01-23; Implementation: 01-03-23) A. Fee- For-Service Medicare Medicare edits CAR T -cell therapy claims based on requirements found in NCD 110.24. B. Beneficiaries enrolled in Medicare Advantage (MA) plans Effective for clams with dates of service on and after August 7, 2019, CMS determined that the NCD requiring coverage of CAR T -cell therapy for cancer is a significant cost under section 422.109(a)(2) of title 42 of the Code of Federal Regulations. As a result, for CYs 2019 (beginning August 7, 2019) and 2020 only, original fee- for-service Medicare will pay for CAR T- cell therapy for cancer obtained by beneficiaries enrolled in Medicare Advantage (MA) plans when the coverage criteria outlined in the NCD are met. Plans should account for CAR T- cell therapy for cancer items and services in their contract year 2021 bids. Consistent with 1862 (t)(2) of the Act, MACs will pay for CAR T- cell therapy for cancer for Medicare beneficiaries enrolled in MA plans in CYs 2019 (beginning August 7, 2019) and 2020. 410 Acupuncture for Chronic Low Back Pain (cLBP) (Rev. 10337, Issued: 08-027-20, Effective: 01-21-20, Implementation: 06 -24 - 20 - A/B MACs; 10 -05-20- SSM Edits; 01 - 04-21 - BR 13 CWF only) Acupuncture is the selection and manipulation of specific acupuncture points through the insertion of needles or needling, or other non-needling techniques focused on these points. 410.1 - Coverage Requirements (Rev. 10337, Issued: 08-027-20, Effective: 01-21-20, Implementation: 06 -24 - 20 - A/B MACs; 10 -05-20- SSM Edits; 01 - 04-21 - BR 13 CWF only) Effective for services on or after January 21, 2020, the Centers for Medicare & Medicaid Services ( CMS) will cover acupuncture for chronic low back pain (cLBP) under section 1862(a)(1)(A) of the Social Security Act. Up to 12 visits in 90 days are covered for Medicare beneficiaries under the following circumstances: For the purpose of this decision, cLBP is defined as: o Lasting 12 weeks or longer; o nonspecific, in that it has no identifiable systemic cause (i.e., not associated with metastatic, inflammatory, infectious, etc. disease); o not associated with surgery; and o not associated with pregnancy. An additional 8 sessions will be covered for those patients demonstrating an improvement. No more than 20 acupuncture treatments may be administered annually. Example: If the 1st service is performed on March 21, 2020, the next service beginning a new year cannot be performed until March 1, 2021. This means 11 full months must pass from the date of the 1st service before eligibility begins again. All types of acupuncture including dry needling for any condition other than cLBP are non- covered by Medicare. 410.2 Claims Processing General Information (Rev. 10337, Issued: 08-027-20, Effective: 01-21-20, Implementation: 06 -24 - 20 - A/B MACs; 10 -05-20- SSM Edits; 01 - 04-21 - BR 13 CWF only) Effective for claims with dates of service (DOS) on or after January 21, 2020, contractors shall recognize acupuncture for cLBP services reported with CPT codes 97810, 97811, 97813, 97814, 20560, and 20561 as covered services under National Coverage Determ ination (NCD) 30.3.3 no more than 20 times per annum. NOTE: If the 1st service is performed on March 21, 2020, the next service beginning a new year cannot be performed until March 1, 2021, 11 full months following the 1st service. The attached includes the International Classification of Diseases (ICD) -10 diagnosis codes are applicable and must be reported for acupuncture for cLBP services: Contractors shall accept and process acupuncture for cLBP claims with the - KX modifier for the 13th through 20th service per annum. NOTE: The 1st through 12th service over a 90- day period do not require the KX modifier. There is a 20 service maximum per annum for this benefit. NOTE: By applying the - KX modifier to the claim, the therapy provider is confirming that the additional services are medically necessary as justified by appropriate documentation in the medical record. 410.3 Institutional Claims Bill Type and Revenue Coding Information (Rev. 10337, Issued: 08- 027-20, Effective: 01 -21-20, Implementation: 06-24 - 20 - A/B MACs; 10 -05-20-SSM Edits; 01 - 04-21 - BR 13 CWF only) Effective for claims with DOS on or after January 21, 2020, contractors shall recognize acupuncture for cLBP services reported on institutional claims on types of bill (TOBs) 12X, 13X, 71X, 77X, and 85X (and revenue codes not equal to 096X, 097X, and 098X for CAH Method I). Effective for claims with DOS on or after January 21, 2020, contractors shall recognize acupuncture for cLBP services reported with Revenue Code 0940 on institutional claims. Effective for claims with DOS on or after January 21, 2020, contractors shall recognize acupuncture for cLBP services reported on institutional claims on TOB 12X, 71X, 77X 85X CAH Method II with revenue codes 096X, 097X, and 098X. 410.4 Messaging (Rev. 10337, Issued: 08- 027-20, Effective: 01 -21-20, Implementation: 06-24 - 20 - A/B MACs; 10 -05-20-SSM Edits; 01 - 04-21 - BR 13 CWF only) Effective for claims with DOS on or after January 21, 2020, contractors shall reject/deny claims that do not contain the appropriate diagnosis/procedure coding noted in section 410.2 and use these messages: Claim Adjustment Reason Code (CARC) 50 - These are non -covered services because this is not deemed a 'medical necessity' by the payer. Remittance Advice Remark Code (RARC) M64 Missing/incomplete/invalid other diagnosis. Group Code CO (Contractual Obligations) or PR (Patient Responsibility) dependent on liability. MSN 15.20 - The following polices were used when we made this decision: NCD 30.3.3. Spanish Version Las siguientes polticas fueron utilizadas cuando se tom esta decisin: NCD 30.3.3. NOTE: Due to system requirement, the Fiscal Intermediary Shared System (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. In addition to the codes noted in section 410.2, contractors shall afford appeal rights to all denied parties. Contractors shall return to provider/return as unprocessable claims for acupuncture for cLBP for services 13 through 20 per annum without the - KX modifier and use these messages: CARC 4 - The procedure code is inconsistent with the modifier used or a required modifier is missing. Usage: Note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. RARC N657 - This should be billed with the appropriate code for these services. Group Code CO Contractors shall reject/deny more than 20 claims per annum for acupuncture for cLBP and use the following messages: CARC 96 - Non -covered charge(s). At least one Remark Code must be provided (may be comprised of either the NCPDP Reject Reason [sic] Code, or Remittance Advice Remark Code that is not an ALERT.) Note: Refer to the 835 Healthcare Policy Identification Segme nt (loop 2110 Service Payment Information REF), if present. RARC N640 - Exceeds number/frequency approved/allowed within time period. Group Code - CO (Contractual Obligation) MSN 15.20 - The following polices were used when we made this decision: NCD 30.3.3. Spanish Version Las siguientes polticas fueron utilizadas cuando se tom esta decisin: NCD 30.3.3. MSN 15.19: We used a Local Coverage Determination (LCD) to decide coverage for your claim. To appeal, get a copy of the LCD at www.cms.gov/medicare -coverage -database (use the MSN Billing Code for the CPT/HCPCS Code) and send with information from your doc tor." Spanish Version - Usamos una Determinacin de Cobertura Local (LCD) para decidir la cobertura de su reclamo. Para apelar, obtenga una copia del LCD en www.cms.gov/medicare -coverage -database (use el cdigo de facturacin de MSN para el cdigo "CPT/HCPCS") y envela con la informacin de su mdico. NOTE: Due to system requirements, the Fiscal Intermediary Shared System 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. 410.5 Common Working File (CWF) FISS, and Multi- Carrier System (MCS) Editing (Rev. 10337, Issued: 08- 027-20, Effective: 01 -21-20, Implementation: 06-24 - 20 - A/B MACs; 10 -05-20-SSM Edits; 01 - 04-21 - BR 13 CWF only) The Common Working File (CWF) shall create a new reject for claims with DOS on and after January 21, 2020, for claims received on or after October 5, 2020, to not allow payment for more than 20 acupuncture for cLBP claims per annum. For acupuncture for cLBP claims CWF, FISS and the Multi -Carrier System (MCS) shall apply appropriate updates to the Next Eligibility Date file for DOS on or after January 21, 2020. NOTE : Appropriate updates include modifications to HUQA, and Extract Records on the Next Generation Desktop (NGD) and the Medicare Beneficiary Database (MBD) for next eligible date and services remaining. CWF shall count 11 full months starting with the month of a beneficiarys 1st acupuncture for cLBP service. EX: If 1st date of service is October 15, 2020, the next eligible date beginning a new year would be October 1, 2021. NOTE: A new cLBP auxiliary (AUX) file will be created and HIMR will be updated to post the previous acupuncture for cLBP HCPCS 97810, 97811, 97813, 97814, 20560, or 20561.

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The Common Working File (CWF) shall create a new reject for claims with DOS on and after January 21, 2020, for claims received on or after October 5, 2020, to not allow payment for more than 20 acupuncture for cLBP claims per annum. For acupuncture for cLBP claims CWF, FISS and the Multi -Carrier System (MCS) shall apply appropriate updates to the Next Eligibility Date file for DOS on or after January 21, 2020. NOTE : Appropriate updates include modifications to HUQA, and Extract Records on the Next Generation Desktop (NGD) and the Medicare Beneficiary Database (MBD) for next eligible date and services remaining. CWF shall count 11 full months starting with the month of a beneficiarys 1st acupuncture for cLBP service. EX: If 1st date of service is October 15, 2020, the next eligible date beginning a new year would be October 1, 2021. NOTE: A new cLBP auxiliary (AUX) file will be created and HIMR will be updated to post the previous acupuncture for cLBP HCPCS 97810, 97811, 97813, 97814, 20560, or 20561. For acupuncture for cLPB claims with DOS on and after January 21, 2020, the Multi -Carrier System Desktop Tool shall display the acupuncture for cLBP visits in a format equivalent to the CWF HIMR screen. Effective for claims with DOS on and after January 21, 2020, received on and after October 5, 2020, CWF shall post acupuncture for cLBP HCPCS codes 97810, 97811, 97813, 97814, 20560, and 20561, reported on institutional claims, TOBs 12X, 13X, 71X, 77X, and 85X (and revenue code not equal to 096X, 097X, 098X), as the technical component on the new cLBP AUX file. NOTE: 1 TECH and 1 PROF on same DOS represents 1 service. NOTE: CWF shall post the Part B Professional claim line as TECH/PROF for the HCPCS if the modifier is blank. CWF shall create a new reject for HCPCS 97810, 97811, 97813, 97814, 20560, and 20561 when a beneficiary has reached 20 acupuncture for cLBP sessions and the - KX modifier is not included on the claim line for sessions 13 through 20 (the reject will apply fo r both PROF and TECH sessions). CWF shall update the determination when any changes occur to the beneficiary master data or claims data that would result in a change to the calculation CWF shall create a new HICR function for the new cLBP AUX file. 411 Home Infusion Therapy Services (Rev. 10269, Issued: 08- 07-2020, Effective: 01 -01-2021, Implementation: 01- 04-2021) 411.1 Policy (Rev. 10269, Issued: 08- 07-2020, Effective: 01 -01-2021, Implementation: 01- 04-2021) Effective beginning on January 1, 2021, the Medicare home infusion therapy benefit covers the professional services, including nursing services, furnished in accordance with the plan of care, patient training and education (not otherwise covered under the durable medical equipment benefit), remote monitoring, and monitoring services for the provision of home infusion therapy and home infusion drugs furnished by a qualified home infusion therapy supplier. Home infusion therapy means the items and services fu rnished by a qualified home infusion therapy supplier, which are furnished in the individuals home. Payment is for an infusion drug administration calendar day, which means the day on which home infusion therapy services are furnished by skilled profess ionals in the individuals home on the day of infusion drug administration. The skilled services provided on such day must be so inherently complex that they can only be safely and effectively performed by, or under the supervision of, professional or technical personnel. 411.2 Coverage Requirements (Rev. 10269, Issued: 08- 07-2020, Effective: 01 -01-2021 Implementation: 01- 04-2021) Payment for an infusion drug administration calendar day is only made if a beneficiary is furnished certain drugs and biologicals administered through an item of covered DME, and payable only to suppliers enrolled in Medicare as a qualified home infusion therapy supplier. The beneficiary must be under the care of an applicable provider, defined as a physician, nurse practitioner, or physicians assistant, and must be under the care of a physician- established plan of care that prescribes the type, amount , and duration of infusion therapy services. A qualified home infusion therapy supplier is a pharmacy, physician, or other provider of services or supplier licensed by the state in which supplies or services are furnished. Qualified home infusion therapy suppliers must furnish infusion therapy to individuals with acute or chronic conditions requiring administration of home infusion drugs; ensure the safe and effective provision and administration of home infusion therapy on a 7 -day-a-week, 24- hour-a-day basis; and be accredited by an organization designated by the Secretary. The supplier may subcontract with a pharmacy, physician, other qualified supplier or provider of services in order to meet these requirements. 411.3 - Home Infusion Drugs: Healthcare Common Procedural Coding System (HCPCS) Drug Codes (Rev. 11430; Issued: 05- 24-22; Effective: 07 -01-22; Implementation: 07 -05-22) The home infusion therapy services payment is intended to cover the professional services needed for the administration of certain home infusion drugs covered as supplies necessary for the effective use of external infusion pumps. This payment separately and explicitly pays for the services related to the administration of the drugs identified on the DME LCD for External Infusion Pumps, when such services are furnished in the individuals home. Section 1861(iii)(3)(C) of the Act defines home infusion drug as a parenteral drug or biological administered intravenously, or subcutaneously for an administration p eriod of 15 minutes or more, in the home of an individual through a pump that is an item of durable medical equipment (as defined in section 1861(n) of the Act). Such term does not include insulin pump systems or self -administered drugs or biologicals on a self -administered drug exclusion list. Home infusion drugs are assigned to three payment categories, as determined by the HCPCS J -code. Payment category 1 includes certain intravenous antifungals and antivirals, uninterrupted long- term infusions, pain management, inotropic, chelation drugs. Payment category 2 includes subcutaneous immunotherapy and other certain subcutaneous infusion drugs. Payment category 3 includes certain chemotherapy drugs. CMS will continue to use the G -codes, established for the temporary transitional payments in CYs 2019 and 2020, for the professional services furnished on an infusion drug administration calendar day for each payment category. CMS has established a single payment amount for each of the three categories for professional services furnished for each infusion drug administration calendar day. Each payment category will be paid at amounts in accordance with infusion codes and units for such codes under the physician fee schedule for each infusion drug administration calendar day in the individuals home for drugs assigned to such category. The payment amounts are equal to 5 hours of infusion therapy in a physicians office. Further policy information can be found in Publication 100- 02, Chapter 15, Section 320. Category 1 J-Code Description J0133 Injection, acyclovir, 5 mg J0285 Injection, amphotericin b, 50 mg J0287 Injection, amphotericin b lipid complex, 10 mg J0288 Injection, amphotericin b cholesteryl sulfate complex, 10 mg J0289 Injection, amphotericin b liposome, 10 mg J0895 Injection, deferoxamine mesylate, 500 mg J1170 Injection, hydromorphone, up to 4 mg J1250 Injection, dobutamine hydrochloride, per 250 mg J1265 Injection, dopamine hcl, 40 mg J1325 Injection, epoprostenol, 0.5 mg J1455 Injection, foscarnet sodium, per 1000 mg J1457 Injection, gallium nitrate, 1 mg J1570 Injection, ganciclovir sodium, 500 mg J2175 Injection, meperidine hydrochloride, per 100 mg J2260 Injection, milrinone lactate, 5 mg J2270 Injection, morphine sulfate, up to 10 mg J3010 Injection, fentanyl citrate, 0.1 mg J3285 Injection, treprostinil, 1 mg Category 2 J-Code Description J1551 JB Injection, immune globulin (cutaquig), 100mg J1555 JB Injection, immune globulin (cuvitru), 100 mg J1558 JB Injection, immune globulin (xembify), 100mg J1559 JB Injection, immune globulin (hizentra), 100mg J1561 JB Injection, immune globulin, (gamunex -c/gammaked), non-lyophilized (e.g. liquid), 500 mg J1562 JB Injection, immune globulin (vivaglobin), 100 mg J1569 JB Injection, immune globulin, (gammagard liquid), non -lyophilized, (e.g., liquid), 500 mg J1575 JB Injection, immune globulin/hyaluronidase, (hyqvia), 100 mg immune globulin J7799 JB This NOC code may be used to identify the subcutaneous immune globulin (cutaquig) Category 3 J-Code Description J9000 Injection, doxorubicin hydrochloride, 10 mg J9039 Injection, blinatumomab, 1 microgram J9040 Injection, bleomycin sulfate, 15 units J9065 Injection, cladribine, per 1 mg J9100 Injection, cytarabine, 100 mg J9190 Injection, fluorouracil, 500 mg J9360 Injection, vinblastine sulfate, 1 mg J9370 Injection, vincristine sulfate, 1 mg It is important to note that this list is not static. The payment category may be determined by the contractor for any new home infusion drug additions to the Local Coverage Determination (LCD) for External Infusion Pumps as identified by the following not-otherwise- classified (NOC) codes : - J7799 - Not otherwise classified drugs, other than inhalation drugs, administered through DME - J7999 - Compounded drug, not otherwise classified. Attachment A: Billing for Home Infusion Therapy Services on or After January 1, 2021 Table 1 shows the time increments providers should report visit length in 15-minute increments (15 minutes = 1 unit). See the table below for the rounding of units: Table 1: Time Increments Unit Time 1 <23 minutes 2 = 23 minutes to <38 minutes 3 = 38 minutes to <53 minutes 4 = 53 minutes to <68 minutes 5 = 68 minutes to <83 minutes 6 = 83 minutes to <98 minutes 7 = 98 minutes to <113 minutes 8 = 113 minutes to <128 minutes 9 = 128 minutes to <143 minutes 10 = 143 minutes to <158 minutes Table 2 shows the use of the three G-codes established for the home infusion therapy benefit, and reflects the therapy type and complexity of the drug administration. Table 2: Payment Categories for Home Infusion Therapy Professional Services (G-Codes) Category 1 Category 2 Category 3 Description

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Table 1 shows the time increments providers should report visit length in 15-minute increments (15 minutes = 1 unit). See the table below for the rounding of units: Table 1: Time Increments Unit Time 1 <23 minutes 2 = 23 minutes to <38 minutes 3 = 38 minutes to <53 minutes 4 = 53 minutes to <68 minutes 5 = 68 minutes to <83 minutes 6 = 83 minutes to <98 minutes 7 = 98 minutes to <113 minutes 8 = 113 minutes to <128 minutes 9 = 128 minutes to <143 minutes 10 = 143 minutes to <158 minutes Table 2 shows the use of the three G-codes established for the home infusion therapy benefit, and reflects the therapy type and complexity of the drug administration. Table 2: Payment Categories for Home Infusion Therapy Professional Services (G-Codes) Category 1 Category 2 Category 3 Description G-Code Intravenous anti -infective, pain management, chelation, pulmonary hypertension, inotropic, and other certain intravenous infusion drugs Subcutaneous immunotherapy and other certain Subcutaneous infusion drugs Chemotherapy and other certain highly complex intravenous drugs Initial Visit G0088 G0089 G0090 Subsequent Visit G0068 G0069 G0070 Table 3 provides a list of J-codes associated with the home infusion drugs that fall within each category. Table 3: Payment Categories for Home Infusion Drugs (J-Codes) Category 1 J-Code Description J0133 Injection, acyclovir, 5 mg J0285 Injection, amphotericin b, 50 mg J0287 Injection, amphotericin b lipid complex, 10 mg J0288 Injection, amphotericin b cholesteryl sulfate complex, 10 mg J0289 Injection, amphotericin b liposome, 10 mg J0895 Injection, deferoxamine mesylate, 500 mg J1170 Injection, hydromorphone, up to 4 mg J1250 Injection, dobutamine hydrochloride, per 250 mg J1265 Injection, dopamine hcl, 40 mg J1325 Injection, epoprostenol, 0.5 mg J1455 Injection, foscarnet sodium, per 1000 mg J1457 Injection, gallium nitrate, 1 mg J1570 Injection, ganciclovir sodium, 500 mg J2175 Injection, meperidine hydrochloride, per 100 mg J2260 Injection, milrinone lactate, 5 mg J2270 Injection, morphine sulfate, up to 10 mg J3010 Injection, fentanyl citrate, 0.1 mg J3285 Injection, treprostinil, 1 mg Category 2 J-Code Description J1551 JB Injection, immune globulin (cutaquig), 100mg J1555 JB Injection, immune globulin (cuvitru), 100 mg J1558 JB Injection, immune globulin (xembify), 100mg J1559 JB Injection, immune globulin (hizentra), 100mg J1561 JB Injection, immune globulin, (gamunex -c/gammaked), non-lyophilized (e.g. liquid), 500 m J1562 JB Injection, immune globulin (vivaglobin), 100 mg J1569 JB Injection, immune globulin, (gammagard liquid), non -lyophilized, (e.g., liquid), 500 mg J1575 JB Injection, immune globulin/hyaluronidase, (hyqvia), 100 mg immune globulin J7799 JB This NOC code may be used to identify the subcutaneous immune globulin (cutaquig) Category 3 J-Code Description J9000 Injection, doxorubicin hydrochloride, 10 mg J9039 Injection, blinatumomab, 1 microgram J9040 Injection, bleomycin sulfate, 15 units J9065 Injection, cladribine, per 1 mg J9100 Injection, cytarabine, 100 mg J9190 Injection, fluorouracil, 500 mg J9360 Injection, vinblastine sulfate, 1 mg J9370 Injection, vincristine sulfate, 1 mg The payment category may be determined by the contractor for any new home infusion drug additions to the Local Coverage Determination (LCD) for External Infusion Pumps as identified by the following not- otherwise- classified (NOC) codes : - J7799 - Not otherwise classified drugs, other than inhalation drugs, administered through DME - J7999 - Compounded drug, not otherwise classified 411.4 - Billing and Payment Requirements (Rev. 10269, Issued: 08-07-2020, Effective: 01- 01-2021, Implementation: 01-04-2021) Contractors shall accept and pay for home infusion therapy services to eligible home infusion therapy suppliers (new specialty D6 ) effective for claim lines with dates of service on or after January 1, 2021 using the one of the following G codes and applicable J codes listed in section 411.3 of this chapter. Claims for the home infusion therapy service G -codes are billed to the A/B MACs and are payable to home infusion therapy suppli ers; this service is no longer payable to DME suppliers. The applicable J codes are billed to the DME MACs by the DME supplier. Contractors shall use Type of Service (TOS) Code 1 for all six G -codes. Contractors shall pay only one of the G -codes per line item date of service when one of the drugs from the applicable category is billed with the same line item date of service or a d ate of service within 30 days prior to the G -code visit. NOTE: The fees associated with the G -codes on the MPFSD fee file will be a per day rate; therefore, the units on the line should not be multiplied by the rate. The drug remains separately payable from the G -code line item Home infusion therapy suppliers will report the following HCPCS G -codes associated with the payment categories for the professional services furnished in the individuals home and on an infusion drug administration calendar day. Because the home infusion therapy services are contingent upon a home infusion drug J -code, home infusion therapy suppliers must ensure that the appropriate drug associated with the visit is billed no more than 30 days prior to the visit. In the event that multiple visits occur on the same date of service, or multiple drugs, which are not all ass igned to the same payment category, are administered on the same infusion drug administration calendar day, a single payment would be made that is equal to the highest payment category. Suppliers must only bill for one visit and should report the highest paying visit with the applicable drug. To differentiate the first visit from all subsequent visits, h ome infusion therapy suppliers may only bill one of the initial visit G -codes to indicate an visit for a new patient who had previously received their last home infusion therapy service visit more than 60 days prior to the new initial home infusion therapy service visit. Home infusion therapy suppliers should report visit length in 15- minute increments (15 minutes=1 unit). See the Table 1 below for the rounding of units. Table 1: Time Increments Unit Time 1 <23 minutes 2 = 23 minutes to <38 minutes 3 = 38 minutes to <53 minutes 4 = 53 minutes to <68 minutes 5 = 68 minutes to <83 minutes 6 = 83 minutes to <98 minutes 7 = 98 minutes to <113 minutes 8 = 113 minutes to <128 minutes 9 = 128 minutes to <143 minutes 10 = 143 minutes to <158 minutes Table 2 shows the use of the G-codes established for the home infusion therapy benefit, and reflects the therapy type and complexity of the drug administration. Table 2: Payment Categories for Home Infusion Therapy Professional Services (G-Codes) Category 1 Category 2 Category 3 Description G-Code Intravenous anti- infective, pain management, chelation, pulmonary hypertension, inotropic, and other certain intravenous infusion drugs Subcutaneous immunotherapy and other certain Subcutaneous infusion drugs Chemotherapy and other certain highly complex intravenous drugs Initial Visit G0088 G0089 G0090 Subsequent Visit G0068 G0069 G0070 G0068: Professional services for the administration of anti- infective, pain management, chelation, pulmonary hypertension, inotropic, or other intravenous infusion drug or biological (excluding chemotherapy or other highly complex drug or biological) for each infusion drug administration calendar day in the individuals home, each 15 minutes Short Descriptor: Adm IV infusion drug in home G0069: Professional services for the administration of subcutaneous immunotherapy or other subcutaneous infusion drug or biological for each infusion drug administration calendar day in the individual's home, each 15 minutes Short Descriptor: Adm SQ infusion drug in home G0070: Professional services for the administration of intravenous chemotherapy or other intravenous highly complex drug or biological infusion for each infusion drug administration calendar day in the individual's home, each 15 minutes. Short Descriptor: Adm of IV chemo drug in home G0088: Professional services, initial visit, for the administration of anti- infective, pain management, chelation, pulmonary hypertension, inotropic, or other intravenous infusion drug or biological (excluding chemotherapy or other highly complex drug or biologic al) for each infusion drug administration calendar day in the individuals home, each 15 minutes. Short Descriptor: Adm IV drug 1st home visit G0089: Professional services, initial visit, for the administration of subcutaneous immunotherapy or other subcutaneous infusion drug or biological for each infusion drug administration calendar day in the individual's home, each 15 minutes. Short Descriptor: Adm SubQ drug 1st home visit G0090: Professional services, initial visit, for the administration of intravenous chemotherapy or other highly complex infusion drug or biological for each infusion drug administration calendar day in the individual's home, each 15 minutes. Short Descriptor: Adm IV chemo 1st home visit 411.5 Claim Adjustment Reason Codes, Remittance Advice Remark Codes, Group Codes, and Medicare Summary Notice Messages (Rev. 10269, Issued: 08- 07-2020, Effective: 01 -01-2021, Implementation: 01- 04-2021) Contractors shall deny the CWF rejected claim if a new G -code is received for the same date of service as a previous claim was paid for the same line item date of service. NOTE: The provider should submit an adjustment to the original claim to receive the higher payment. Contractors shall use the following CARC/RARC codes when denying claims: CARC 97 - The benefit for this service is included in the payment/allowance for another service/procedure that has already been adjudicated. Usage: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. RARC N111 - No appeal right except duplicate claim/service issue. This service was included in a claim that has been previously billed and adjudicated. Claim Adjustment Group Code - CO (Contractual Obligation) MSN message: 41.14: This service/item was billed incorrectly. 41.14- Este servicio o artculo fue facturado incorrectamente. Contractors shall deny the CWF rejected G -code line when the claim has recycled three times without finding the associated drug J -code claim and use the following messages:

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Contractors shall deny the CWF rejected claim if a new G -code is received for the same date of service as a previous claim was paid for the same line item date of service. NOTE: The provider should submit an adjustment to the original claim to receive the higher payment. Contractors shall use the following CARC/RARC codes when denying claims: CARC 97 - The benefit for this service is included in the payment/allowance for another service/procedure that has already been adjudicated. Usage: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. RARC N111 - No appeal right except duplicate claim/service issue. This service was included in a claim that has been previously billed and adjudicated. Claim Adjustment Group Code - CO (Contractual Obligation) MSN message: 41.14: This service/item was billed incorrectly. 41.14- Este servicio o artculo fue facturado incorrectamente. Contractors shall deny the CWF rejected G -code line when the claim has recycled three times without finding the associated drug J -code claim and use the following messages: CARC 16 - Claim/service lacks information or has submission/billing error(s). Usage: Do not use this code for claims attachment(s)/other documentation. At least one Remark Code must be provided (may be comprised of either the NCPDP Reject Reason Code, or R emittance Advice Remark Code that is not an ALERT.) Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present. RARC N657 - This should be billed with the appropriate code for these services. Claim Adjustment Group Code - CO (Contractual Obligation) MSN message: 41.14: This service/item was billed incorrectly. 41.14- Este servicio o artculo fue facturado incorrectamente. Contractors shall deny CWF rejected claims for more than one claim line service of G0088, G0089, or G0090 within a 60 day period and use the following messages: CARC 96 - Non -covered charge(s). At least one Remark Code must be provided (may be comprised of either the NCPDP Reject Reason [sic] Code, or Remittance Advice Remark Code that is not an ALERT.) Note: Refer to the 835 Healthcare Policy Identification Segme nt (loop 2110 Service Payment Information REF), if present. RARC N640 - Exceeds number/frequency approved/allowed within time period. Group Code - CO (Contractual Obligation) 411.6 CWF and MCS Editing Requirements (Rev. 10269, Issued: 08- 07-2020, Effective: 01 -01-2021, Implementation: 01- 04-2021) MCS shall create a new edit to identify when there is more than one of the following six HCPCS G0068, G0069 G0070, G0088, G0089, or G0090 with Date of Service on or after 1/1/2021 for the same Date of Service on the same Part B Professional cla im. CWF shall create a new reject for a Part B Professional claim with one of the following six HCPCS codes G0068, G0069 G0070, G0088, G0089, or G0090 with Date of Service on or after 1/1/2021 and there is no DME claim in history with one of the identified J-codes within 30 days prior to the incoming Date of Service. NOTE : This edit shall have override capability at the claim detail line CWF and contractors shall recycle G0068, G0069 G0070, G0088, G0089, or G0090 claim up to three times for a total of 15 days until a claim containing an allowable drug J -code from above is received with the same line item date of service or with in 30 days prior to the line item date of service of the G -code. CWF shall create a new reject for a Part B Professional claim with one of the following six G0068, G0069 G0070, G0088, G0089, or G0090 codes with a Date of Service on or after 1/1/2021 when there is a Part B claim in history with one of the ide ntified six G0068, G0069 G0070, G0088, G0089, or G0090 codes for the same Date of Service. NOTE : This edit shall have override capability at the claim detail line CWF shall create a new reject for a Part B Professional claim with one of the new G0088, G0089, or G0090 codes and in history is an allowed DME or Part B Professional claim with any of the six G0068, G0069 G0070, G0088, G0089, or G0090 codes and the Dates of Service is within 60 days prior to the incoming claims Dates of Service. The incoming claim has Dates of Service on or after 1/1/2021. CWF should still subject an incoming Part B Professional claim to the edit if it is within 60 days of posted DME claim, and if the claim in history is DME and has one of the three existing G0068, G0069 G0070 codes and has Dates of Service prior to 1/1/2021. CWF shall create a new Informational Unsolicited Response (IUR) when a Part B Professional claim or a DME claim with one of the six G0068, G0069 G0070, G0088, G0089, or G0090 codes is received and in history is a Part B Professional claim with one of the three new G0088, G0089, or G0090 codes with Dates of Service within 60 days after the incoming claims Dates of Service. CWF shall ensure that all new edits and the IUR appear on the ORPN Report. Transmittals Issued for this Chapter Rev # Issue Date Subject Impl Date CR# R12533CP 03/07/2024 Update to the Internet Only Manual (IOM) Publication (Pub.) 100-04, Chapter 32, Section 90 for Coding Revisions to the National Coverage Determinations (NCDs) --July 2024 Change Request (CR) 13507. 04/08/2024 13545 R12497CP 02/08/2024 Pulmonary Rehabilitation, Cardiac Rehabilitation and Intensive Cardiac Rehabilitation (PR/CR/ICR) Expansion of Supervising Practitioners 03/12/2024 13513 R12435CP 12/28/2023 Update to the Internet Only Manual (IOM) Publication (Pub.) 100-04, Chapter 18, Sections 20.2, 60.3 and Chapter 32, Sections 50.4.1, 200.2 for Coding Revisions to the National Coverage Determinations (NCDs) --April 2024 Change Request (CR) 13391 01/29/2024 12435 R12396CP 12/07/2023 Update to the Internet Only Manual (IOM) Publication (Pub.) 100-04, Chapter 32 Sections 320.3.3 and 370.1 for Coding Revisions to the National Coverage Determinations (NCDs) --April 2024 Change Request (CR) 13390 01/09/2024 13438 R12109CP 06/29/2023 Update to the Internet Only Manual (IOM) Publication (Pub.) 100-04, Chapter 32 Sections 130.1, for International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs) --October 2023 Update Change Request (CR) 13166 10/02/2023 13227 R11902CP 03/16/2023 Update to the Internet Only Manual (IOM) Publication (Pub.) 100-04, Chapter 18 Sections 50.3-50.4, and Chapter 32 Sections 130.1, 170.2 for Coding Revisions to National Coverage Determinations (NCDs) --July 2023 Change Request (CR) 13070 04/17/2023 13104 R11875CP 02/23/2023 National Coverage Determination (NCD) 50.3 - Cochlear Implantation Manual Update 03/24/2023 13073 Rev # Issue Date Subject Impl Date CR# R11789CP 01/19/2023 Update to the Internet Only Manual (IOM) For Alpha-Numerical Order in Publication (Pub.) 100-04, Chapter 32, Index, Sections 40.2.1 and 40.2.4 02/21/2023 13025 R11759CP 12/21/2022 Update to the Internet Only Manual (IOM) Publication (Pub.) 100-04, Chapter 18 Section 170.1 and Chapter 32 Section 270.2 due to the National Coverage Determinations (NCDs) April 2023 Change Request (CR) 12960 01/23/2023 12993 R11721CP 11/28/2022 National Coverage Determination (NCD 110.24): Chimeric Antigen Receptor (CAR) T-cell Therapy 01/03/2023 12928 R11430CP 05/24/2022 Update to 'J' Drug Code List for Billing Home Infusion Therapy (HIT) Services 07/05/2022 12667 R11426CP 05/20/2022 An Omnibus CR Covering: (1) Removal of Two National Coverage Determination (NCDs), (2) Updates to the Medical Nutrition Therapy (MNT) Policy, and (3) Updates to the Pulmonary Rehabilitation (PR), Cardiac Rehabilitation (CR), and Intensive Cardiac Rehabilitation (ICR) Conditions of Coverage- Rescinded and replaced by transmittal 11426 07/05/2022 12613 R11272CP 02/18/2022 An Omnibus CR Covering: (1) Removal of Two National Coverage Determination (NCDs), (2) Updates to the Medical Nutrition Therapy (MNT) Policy, and (3) Updates to the Pulmonary Rehabilitation (PR), Cardiac Rehabilitation (CR), and Intensive Cardiac Rehabilitation (ICR) Conditions of Coverage

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05/20/2022 An Omnibus CR Covering: (1) Removal of Two National Coverage Determination (NCDs), (2) Updates to the Medical Nutrition Therapy (MNT) Policy, and (3) Updates to the Pulmonary Rehabilitation (PR), Cardiac Rehabilitation (CR), and Intensive Cardiac Rehabilitation (ICR) Conditions of Coverage- Rescinded and replaced by transmittal 11426 07/05/2022 12613 R11272CP 02/18/2022 An Omnibus CR Covering: (1) Removal of Two National Coverage Determination (NCDs), (2) Updates to the Medical Nutrition Therapy (MNT) Policy, and (3) Updates to the Pulmonary Rehabilitation (PR), Cardiac Rehabilitation (CR), and Intensive Cardiac Rehabilitation (ICR) Conditions of Coverage 07/05/2022 12613 R11214CP 01/20/2022 National Coverage Determination (NCD) 270.3 Blood-Derived Products for Chronic, Non-Healing Wounds 01/03/2022 12403 R11171CP 01/12/2022 National Coverage Determination (NCD) 270.3 Blood-Derived Products for Chronic, Non-Healing Wounds Rescinded and replaced by transmittal 11 214 01/03/2022 12403 R11119CP 11/13/2021 National Coverage Determination (NCD) 270.3 Blood-Derived Products for Chronic, Non-Healing Wounds Rescinded and replaced 01/03/2022 12403 Rev # Issue Date Subject Impl Date CR# by transmittal 111 71 R11035CP 10/13/2021 Revisions to Chapters 3, 18, and 32 to Update Coding 10/13/2021 12377 R11021CP 10/01/2021 Revisions To Chapters 13, 18 And 32 To Update Coding 10/29/2021 12376 R10981CP 09/10/2021 National Coverage Determination (NCD) 270.3 Blood-Derived Products for Chronic, Non-Healing Wounds - Rescinded and replaced by transmittal 11119 01/03/2022 12403 R10985CP 09/08/2021 Claims Processing Instructions for National Coverage Determination 20.33 - Transcatheter Edge- to-Edge Repair [TEER] for Mitral Valve Regurgitation 10/08/2021 12361 R10881CP 08/06/2021 REVISIONS TO CHAPTERS 13 AND 32 TO UPDATE CODING 09/07/2021 12069 R10891CP 07/20/2021 National Coverage Determination (NCD 110.24): Chimeric Antigen Receptor (CAR) T-cell Therapy - This CR Rescinds and Fully Replaces CR 11783. 230.2222 09/20/2021 12177 R10796CP National Coverage Determination (NCD 110.24): Chimeric Antigen Receptor (CAR) T-cell Therapy - This CR Rescinds and Fully Replaces CR 11783- Rescinded and replaced by transmittal 10891 07/23/2021 12177 R10837CP 06/11/2021 National Coverage Determination (NCD) 20.9.1 Ventricular Assist Devices (VADs) 07/27/2021 12290 R10796CP 05/20/2021 National Coverage Determination (NCD 110.24): Chimeric Antigen Receptor (CAR) T-cell Therapy - This CR Rescinds and Fully Replaces CR 11783. - Rescinded and replaced by transmittal 10891 07/23/2021 12177 R10573CP 03/24/2021 Update to Pulmonary Rehabilitation (PR), Cardiac Rehabilitation (CR) and Intensive Cardiac Rehabilitation (ICR) Program Manual Sections 04/26/2021 12115 R10547CP 12/31/2020 Billing for Home Infusion Therapy Services On or After January 1, 2021 01/04/2021 11880 R10463CP 11/13/2020 Billing for Home Infusion Therapy Services On or After January 1, 2021 01/04/2021 11880 Rev # Issue Date Subject Impl Date CR# R10343CP 09/04/2020 Update to the Internet Only Manual (IOM) Publication (Pub.) 100-04, Chapter 32, Section 40.2.1 and 40.2.4 10/06/2020 11950 R10337CP 08/27/2020 National Coverage Determination (NCD30.3.3): Acupuncture for Chronic Low Back Pain (cLBP) 01/04/2021 11755 R10269CP 08/07/2020 Billing for Home Infusion Therapy Services On or After January 1, 2021- Rescinded and replaced by transmittal 10463 01/04/2021 11880 R10229CP 07/21/2020 Modify Edits in the Fee for Service (FFS) System When a Beneficiary has a Medicare Advantage (MA) Plan 10/05/2020 11580 R10179CP 06/10/2020 NCD (20.32) Transcatheter Aortic Valve Replacement (TAVR) 06/12/2020 11660 R10128CP 05/08/2020 National Coverage Determination (NCD30.3.3): Acupuncture for Chronic Low Back Pain (cLBP) Rescinded and replaced by transmittal 10337 01/04/2021 11755 R10071CP 05/01/2020 Modify Edits in the Fee for Service (FFS) System When a Beneficiary has a Medicare Advantage (MA) Plan Rescinded and replaced by transmittal 10229 10/05/2020 11580 R4546CP 03/13/2020 NCD (20.32) Transcatheter Aortic Valve Replacement (TAVR) Rescinded and replaced by transmittal 10179 06/12/2020 11660 R4237CP 02/08/2019 Update to the Internet -Only -Manual (IOM) Publication (Pub.) 100-04, Chapter 32, Section 12.1 03/12/2019 11127 R4222CP 02/01/2019 Update to Intensive Cardiac Rehabilitation (ICR) Programs 03/19/2019 11117 R4203CP 01/18/2019 Update to Pub. 100 -04 Chapter 32 to Provide Language-Only Changes for the New Medicare Card Project 02/19/2019 11118 R4111CP 08/10/2018 Revisions to Medicare Claims Processing Manual for Foreign, Emergency and Shipboard Claims 09/11/2018 10856 R4049CP 05/11/2018 Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD) 07/02/2018 10295 Rev # Issue Date Subject Impl Date CR# R4016CP 04/03/2018 Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD) 07/02/2018 10295 R4013CP 03/30/2018 Institutional Billing for No Cost Items 06/29/2018 10521 R3969CP 02/02/2018 Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD) 04/03/2018 10295 R203NCD 11/17/2017 Hyperbaric Oxygen (HBO) Therapy (Section C, Topical Application of Oxygen) 12/18/2017 10220 R3898CP 10/27/2017 Correction to Prevent Payment on Inpatient Information Only Claims for Beneficiaries Enrolled in Medicare Advantage Plans 04/02/2018 10238 R3871CP 09/29/2017 Revisions to Medicare Claims Processing Manual for Foreign, Emergency and Shipboard Claims 10/30/2017 10287 R3848CP 08/25/2017 Updates to Pub. 100 -04, Chapter 18 Preventive and Screening Services and Chapter 32 Billing Requirements for Special Services and Publication 100-03, Chapter 1 Coverage Determinations Part 4

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09/26/2017 10199 R3815CP 07/28/2017 National Coverage Determination (NCD20.8.4): Leadless Pacemakers 08/29/2017 10117 R3811CP 07/25/2017 Percutaneous Image -guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS) 06/27/2017 10089 R3805CP 07/11/2017 Percutaneous Image -guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS) Rescinded and replaced by transmittal 3811 08/11/2017 10089 R3787CP 05/26/2017 Percutaneous Image -guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS) Rescinded and replaced by transmittal 3805 06/27/2017 10089 R3556CP 07/01/2016 Stem Cell Transplantation for Multiple Myeloma, Myelofibrosis, Sickle Cell Disease, and Myelodysplastic Syndromes 10/03/2016 9620 R3509CP 04/29/2016 Stem Cell Transplantation for Multiple Myeloma, Myelofibrosis, Sickle Cell Disease, and Myelodysplastic Syndromes - Rescinded and replaced by Transmittal 3556 10/03/2016 9620 Rev # Issue Date Subject Impl Date CR# R3384CP 10/26/2015 National Coverage Determination (NCD) for Single Chamber and Dual Chamber Permanent Cardiac Pacemakers - This CR rescinds and fully replaces CR 8525 07/06/2015 9078 R3287CP 06/30/2015 Revisions to Medicare Claims Processing Manual for Foreign, Emergency and Shipboard Claims 04/21/2015 8940 R3265CP 05/22/2015 NCD20.30 Microvolt T -wave Alternans (MTWA) 06/23/2015 9162 R3241CP 04/24/2015 Transcatheter Mitral Valve Repair (TMVR) -National Coverage Determination (NCD) 04/06/2014 9002 R3199CP 02/20/2015 Revisions to Medicare Claims Processing Manual for Foreign, Emergency and Shipboard Claims Rescinded and replaced by Transmittal 3287 04/21/2015 8940 R3204CP 02/20/2015 National Coverage Determination (NCD) for Single Chamber and Dual Chamber Permanent Cardiac Pacemakers - This CR rescinds and fully replaces CR 8525 - Rescinded and replaced by Transmittal 3384 07/06/2015 9078 R3181CP 01/30/2015 Implementation of New NUBC Condition Code 53 Initial placement of a medical device provided as part of a clinical trial or a free sample 07/06/2015 8961 R3175CP 01/30/2015 Percutaneous Image -guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS) -Blinded Clinical Trial Follow-Up CR to Implement a Second Claims Processing Procedure Code 03/02/2015 8954 R3142CP 12/05/2014 Transcatheter Mitral Valve Repair (TMVR) -National Coverage Determination (NCD) Rescinded and replaced by Transmittal 3241 04/06/2014 9002 R3105CP 11/06/2014 Medicare Coverage of Items and Services in Category A and B Investigational Device Exemption (IDE) Studies 01/05/2015 8921 R3084CP 10/03/2014 Intensive Cardiac Rehabilitation Program - Benson- Henry Institute Cardiac Wellness Program 11/04/2014 8894 R3058CP 08/29/2014 Cardiac Rehabilitation Programs for Chronic Heart Failure 08/18/2014 8758 Rev # Issue Date Subject Impl Date CR# R3054CP 08/29/2014 Ventricular Assist Devices for Bridge -to-Transplant and Destination Therapy 09/30/2014 8803 R3050CP 08/22/2014 Extracorporeal Photopheresis 09/23/2014 8808 R2998CP 07/25/2014 Update to Pub. 100 -04, Chapter 32 to Provide Language-Only Changes for Updating ICD-10 and ASC X12 08/25/2014 8693 R2989CP 07/18/2014 Cardiac Rehabilitation Programs for Chronic Heart Failure Failure Rescinded and replaced by Transmittal 3058 08/18/2014 8758 R2959CP 05/16/2014 Percutaneous Image -guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS) 10/06/2014 8757 R2955CP 05/14/2014 Mandatory Reporting of an 8 -Digit Clinical Trial Number on Claims 01/06/2014 8401 R2872CP 02/06/2014 National Coverage Determination (NCD) for Single Chamber and Dual Chamber Permanent Cardiac Pacemakers Rescinded and replaced by Transmittal 2986 07/07/2014 8525 R2841CP 12/23/2013 Bariatric Surgery for Treatment of Co -Morbid Conditions Related to Morbid Obesity 12/17/2013 8484 R2827CP 11/29/2013 Transcatheter aortic valve replacement (TAVR) - Implementation of Permanent CPT Code 01/06/2013 8537 R2816CP 11/15/2013 Bariatric Surgery for Treatment of Co -Morbid Conditions Related to Morbid Obesity Rescinded and replaced by Transmittal 2841 12/17/2013 8484 R2805CP 10/30/2013 Mandatory Reporting of an 8 -Digit Clinical Trial Number on Claims Rescinded and replaced by Transmittal 2955 01/06/2014 8401 R2783CP 09/10/2013 Corrections to the Medicare Claims Processing Manual 09/17/2013 8343 R2758CP 08/09/2013 Mandatory Reporting of an 8 -Digit Clinical Trial Number on Claims Rescinded and replaced by Transmittal 2805 01/06/2014 8401 R2743CP 07/25/2013 Coding Changes to Ultrasound Diagnostic Procedures for Transesophageal Doppler Monitoring 08/26/2013 8330 R2737CP 07/11/2013 National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR) Implementation of Mandatory Reporting of Clinical Trial Number 10/07/2013 8255 Rev # Issue Date Subject Impl Date CR# R2728CP 06/14/2013 Ocular Photodynamic Therapy (OPT) with Verteporfin for Macular Degeneration 07/16/2013 8292 R2725CP 06/14/2013 Corrections to the Medicare Claims Processing Manual Rescinded and replaced by Transmittal 2783 09/17/2013 8343 R2720CP 06/10/2013 Autologous Platelet -Rich Plasma (PRP) for Chronic Non -Healing Wounds 07/01/2013 8213 R2710CP 05/21/2013 Autologous Platelet -Rich Plasma (PRP) for Chronic Non-Healing Wounds Rescinded and replaced by Transmittal 2720 07/01/2013 8213 R2689CP 05/03/2013 National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR) Implementation of Mandatory Reporting of Clinical Trial Number Rescinded and replaced by Transmittal 2737 10/07/2013 8255 R2666CP 03/08/2013 Autologous Platelet -Rich Plasma (PRP) for Chronic Non-Healing Wounds Rescinded and replaced by Transmittal 2710 07/01/2013 8213 R2641CP 01/29/2013 Bariatric Surgery for the Treatment of Morbid Obesity National Coverage Determination, Addition of Laparoscopic Sleeve Gastrectomy (LSG ) 02/28/2013 8028 R2628CP 01/07/2013 NCD: Transcatheter Aortic Valve Replacement (TAVR) Coding Update/Policy Clarification 04/01/2013 8168 R2590CP 11/09/2012 Bariatric Surgery for the Treatment of Morbid Obesity National Coverage Determination, Addition of Laparoscopic Sleeve Gastrectomy (LSG ) Rescinded and replaced by Transmittal 2641 12/10/2012 8028 R2252CP 09/24/2012 National Coverage Determination (NCD) FOR Transcatheter Aortic Valve Replacement 01/07/2013 7897 R2551CP 09/24/2012 Extracorporeal Photopheresis (ICD -10) Rescinded and replaced by Transmittal 2551 10/01/2012 7806 R2544CP 09/13/2012 Contractor and Common Working File (CWF) Additional Instructions Related to Change Request (CR) 7633-Screening and Behavioral Counseling Interventions in Primary Care to Reduce Alcohol Misuse 10/01/2012 7791 R2543CP 09/07/2012 Extracorporeal Photopheresis (ICD -10) Rescinded and replaced by Transmittal 2551 10/01/2012 7806 Rev # Issue Date Subject Impl Date CR# R2512CP 08/03/2012 National Coverage Determination (NCD) FOR Transcatheter Aortic Valve Replacement rescinded and Replaced by Transmittal 2552 01/07/2013 7897 R2506CP 08/03/2012 Extracorporeal Photopheresis (ICD -10) Rescinded and replaced by Transmittal 2543 10/01/2012 7806 R2494CP 07/10/2012 Extracorporeal Photopheresis (ICD -10) Rescinded and replaced by Transmittal 2506 10/01/2012 7806 R2488CP 06/21/2012 Contractor and Common Working File (CWF) Additional Instructions Related to Change Request (CR) 7633-Screening and Behavioral Counseling Interventions in Primary Care to Reduce Alcohol Misuse Rescinded and replaced by Transmittal 2544 10/01/2012 7791 R2473CP 05/18/2012 Extracorporeal Photopheresis (ICD -10) 10/01/2012 7806 R2454CP 04/26/2012 Contractor and Common Working File (CWF) Additional Instructions Related to Change Request (CR) 7633-Screening and Behavioral Counseling Interventions in Primary Care to Reduce Alcohol Misuse Rescinded and replaced by Transmittal 2488 10/01/2012 7791 R2394CP 01/25/2012 CWF Editing for

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2543 10/01/2012 7806 R2494CP 07/10/2012 Extracorporeal Photopheresis (ICD -10) Rescinded and replaced by Transmittal 2506 10/01/2012 7806 R2488CP 06/21/2012 Contractor and Common Working File (CWF) Additional Instructions Related to Change Request (CR) 7633-Screening and Behavioral Counseling Interventions in Primary Care to Reduce Alcohol Misuse Rescinded and replaced by Transmittal 2544 10/01/2012 7791 R2473CP 05/18/2012 Extracorporeal Photopheresis (ICD -10) 10/01/2012 7806 R2454CP 04/26/2012 Contractor and Common Working File (CWF) Additional Instructions Related to Change Request (CR) 7633-Screening and Behavioral Counseling Interventions in Primary Care to Reduce Alcohol Misuse Rescinded and replaced by Transmittal 2488 10/01/2012 7791 R2394CP 01/25/2012 CWF Editing for Autologuous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer (PROVENGE) 07/02/2012 7659 R2380CP 01/06/2012 Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer 08/08/2011 7431 R2339CP 11/02/2011 Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer - Rescinded and replaced by Transmittal 2380 08/08/2011 7431 R2254CP 07/08/2011 Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer Rescinded and replaced by Transmittal 2339 08/08/2011 7431 R2113CP 12/10/2010 Payment for 510k Post -Approval Extension Studies Using 501k- Cleared Embolic Protection Devices During Carotid Artery Stenting (CAS) Procedures 01/12/2011 7249 R2105CP 11/24/2010 Dermal Injections for Treatment of Facial Lipodystrophy Syndrome (LDS) 07/06/2010 6953 R2062CP 10/08/2010 Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for Myelodysplastic Syndrome (MDS) 11/10/2010 7137 Rev # Issue Date Subject Impl Date CR# R2052CP 09/17/2010 Billing and Processing for Healthy Control Group Volunteers in a Qualified Clinical Trial 07/06/2010 6776 R2005CP 07/23/2010 Billing and Claims Processing for Automatic Implantable Cardiac Defibrillator (ICD) Services 08/31/2010 7015 R1994CP 07/02/2010 Billing and Claims Processing for Automatic Implantable Cardiac Defibrillator (ICD) Services - Rescinded and replaced by Transmittal 2005 08/31/2010 7015 R1978CP 06/04/2010 Dermal Injections for Treatment of Facial Lipodystrophy Syndrome (LDS) Rescinded and replaced by Transmittal 2105 07/06/2010 6953 R1974CP 05/21/2010 Cardiac Rehabilitation and Intensive Cardiac Rehabilitation 10/04/2010 6850 R1966CP 05/07/2010 Pulmonary Rehabilitation (PR) Services 10/04/2010 6823 R1925CP 03/05/2010 Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting 04/05/2010 6839 R1924CP 02/26/2010 April 2010 Update of the Hospital Outpatient Prospective Payment System (OPPS) 04/05/2010 6857 R1901CP 01/29/2010 Billing and Processing for Healthy Control Group Volunteers in a Qualified Clinical Trial Rescinded and replaced by Transmittal 2052 07/06/2010 6776 R1889CP 01/08/2010 Pharmacogenomic Testing for Warfarin Response 04/05/2010 6715 R1882CP 12/21/2009 January 2010 Update of the Hospital Outpatient Prospective Payment System (OPPS) 01/04/2010 6751 R1871CP 12/11/2009 January 2010 Update of the Hospital Outpatient Prospective Payment System (OPPS) - Rescinded and replaced by Transmittal 1882 01/04/2010 6751 R1877CP 12/18/2009 Instructions Regarding Processing Claims Rejecting for Gender/Procedure Conflict 04/05/2010 6638 R1876CP 12/18/2009 Coverage of Kidney Disease Patient Education Services 04/05/2010 6557 R1839CP 10/28/2009 Instructions Regarding Processing Claims Rejecting for Gender/Procedure Conflict - Rescinded and replaced by Transmittal 1877 04/05/2010 6638 R1816CP 09/17/2009 Fiscal Year (FY) 2010 Inpatient Prospective Payment System (IPPS), Long Term Care Hospital (LTCH) PPS, and Inpatient Psychiatric Facility (IPF) PPS Changes 10/05/2009 6634 Rev # Issue Date Subject Impl Date CR# R1815CP 09/09/2009 Fiscal Year (FY) 2010 Inpatient Prospective Payment System (IPPS), Long Term Care Hospital (LTCH) PPS, and Inpatient Psychiatric Facility (IPF) PPS Changes - Rescinded and replaced by Transmittal 1816 10/05/2009 6634 R1778CP 07/24/2009 Wrong Surgical or Other Invasive Procedure Performed on a Patient; Surgical or Other Invasive Procedure Performed on the Wrong Body Part; Surgical or Other Invasive Procedure Performed on the Wrong Patient 07/06/2009 6405 R1764CP 07/02/2009 Wrong Surgical or Other Invasive Procedure Performed on a Patient; Surgical or Other Invasive Procedure Performed on the Wrong Body Part; Surgical or Other Invasive Procedure Performed on the Wrong Patient Rescinded and replaced by Transmittal 1778 07/06/2009 6405 R1761CP 06/26/2009 Billing Routine Cost of Clinical Trials 09/28/2009 6431 R1755CP 06/12/2009 Wrong Surgical or Other Invasive Procedure Performed on a Patient; Surgical or Other Invasive Procedure Performed on the Wrong Body Part; Surgical or Other Invasive Procedure Performed on the Wrong Patient Rescinded and replaced by Transmittal 1764 07/06/2009 6405 R1743CP 05/22/2009 Billing Routine Cost of Clinical Trials - Rescinded and replaced by Transmittal 1761 07/10/2009 6431 R1742CP 05/22/2009 Clarification of CMS Publication 100 -04, Chapter 32, Section 80.8 Billing of Routine Foot Care When Payment Ceases for Loss of Protective Sensation Evaluation and Management 06/08/2009 6456 R1731CP 05/08/2009 Clarification of CMS Publication 100 -04, Chapter 32, Section 80.8 Billing of Routine Foot Care When Payment Ceases for Loss of Protective Sensation Evaluation and Management - Rescinded and replaced by Transmittal 1742 06/08/2009 6456 R1728CP 05/01/2009 Surgery for Diabetes 05/18/2009 6419 R1723CP 05/01/2009 Ensuring Only Clinical Trial Services Receive Fee-For-Service Payment on Claims Billed for Managed Care Beneficiaries 10/05/2009 6455 Rev # Issue Date Subject Impl Date CR# R1721CP 04/29/2009 Billing Routine Cost of Clinical Trials - Rescinded and replaced by Transmittal 1743 07/10/2009 6431 R1711CP 04/17/2009 Surgery for Diabetes Rescinded and replaced by Transmittal 1728 05/18/2009 6419 R1710CP 04/10/2009 Billing Routine Cost of Clinical Trials - Rescinded and replaced by Transmittal 1721 07/10/2009 6431 R1663CP 01/08/2009 Correction to Prothrombin Time (PT/INR) Monitoring for Home Anticoagulation Management 02/09/2009 6313 R1657CP 12/31/2008 January 2009 Update of the Hospital Outpatient Prospective Payment System (OPPS) 01/05/2009 6320 R1646CP 12/09/2008 Thermal Intradiscal Procedures (TIPs) 01/05/2009 6291 R1593CP 09/12/2008 Smoking and Tobacco Use Cessation Counseling Billing Update for Comprehensive Outpatient Rehabilitation Facilities (CORFs) and Outpatient Physical Therapy Providers (OPTs) 12/12/2008 6163 R1592CP 09/10/2008 Artificial Hearts 12/01/2008 6185 R1583CP 08/29/2008 Artificial Hearts - Replaced by Transmittal 1592 10/06/2008 6185 R1562CP 07/25/2008 Prothrombin Time (PT/INR) Monitoring for Home Anticoagulation Management - Rescinded and replaced by CR 6313 08/25/2008 6138 R1509CP 05/16/2008 Adjusting Inpatient Prospective Payment System (IPPS) Reimbursement for Replaced Devices Offered Without Cost or With a Credit 10/06/2008 5860 R1498CP 05/02/2008 Adjusting Inpatient Prospective Payment System (IPPS) Reimbursement for Replaced Devices Offered Without Cost or With a Credit Replaced by Transmittal 1509 10/06/2008 5860 R1472CP 03/06/2008 Update of Institutional Claims References 04/07/2008 5893 R1433CP 02/01/2008 Smoking and Tobacco Use Cessation Counseling Billing Code Update 07/07/2008 5878 R1430CP 02/01/2008 Use of HCPCS V2787 When Billing Approved Astigmatism-Correcting Intraocular Lens (A-CIOLs) in Ambulatory Surgery Centers (ASCs), Physician Offices, and Hospital Outpatient Departments (HOPDs) 03/03/2008 5853 R1421CP 01/25/2008 Update of Institutional Claims References - Rescinded and Replaced by Transmittal 1472 04/07/2008 5893 Rev # Issue Date Subject Impl Date CR# R1418CP 01/18/2008 New HCPCS Modifiers When Billing for Patient Care in Clinical Research Studies 04/07/2008 5805 R1340CP 09/21/2007 Lumbar Artificial Disc Replacement (LADR) 10/01/2007 5727

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5860 R1472CP 03/06/2008 Update of Institutional Claims References 04/07/2008 5893 R1433CP 02/01/2008 Smoking and Tobacco Use Cessation Counseling Billing Code Update 07/07/2008 5878 R1430CP 02/01/2008 Use of HCPCS V2787 When Billing Approved Astigmatism-Correcting Intraocular Lens (A-CIOLs) in Ambulatory Surgery Centers (ASCs), Physician Offices, and Hospital Outpatient Departments (HOPDs) 03/03/2008 5853 R1421CP 01/25/2008 Update of Institutional Claims References - Rescinded and Replaced by Transmittal 1472 04/07/2008 5893 Rev # Issue Date Subject Impl Date CR# R1418CP 01/18/2008 New HCPCS Modifiers When Billing for Patient Care in Clinical Research Studies 04/07/2008 5805 R1340CP 09/21/2007 Lumbar Artificial Disc Replacement (LADR) 10/01/2007 5727 R1315CP 08/10/2007 Clarification of Percutaneous Transluminal Angioplasty (PTA) Billing Requirements Issued in CR 3811 10/01/2007 5667 R1271CP 06/22/2007 Vagus Nerve Stimulation (VNS) for Resistant Depression 07/23/2007 5612 R1233CP 04/27/2007 Clarification of Bariatric Surgery Billing Requirements Issued in CR 5013 05/29/2007 5477 R1228CP 04/27/2007 Instructions for Implementation of CMS 1536 -R; Astigmatism-Correcting Intraocular Lens (A-C IOLs) 05/29/2007 5527 R1206CP 03/16/2007 Extracorporeal Photopheresis 04/02/2007 5464 R1192CP 03/02/2007 Payment and Billing for Islet Isolation Add -On in National Institutes of Health (NIH) Clinical Trial 04/02/2007 5505 R1164CP 01/26/2007 Coding Change for Lumbar Artificial Disc Replacement (LADR) 03/13/2007 5462 R1147CP 01/05/2007 Intracranial Percutaneous Transluminal Angioplasty (PTA) with Stenting 02/05/2007 5432 R1111CP 11/09/2006 Clarification on Billing for Cryosurgery of the Prostate Gland 04/02/2007 5376 R1042CP 08/25/2006 Clarification on Billing Requirements for Percutaneous Transluminal Angioplasty (PTA) Concurrent With the Placement of an Investigational or FDA -Approved Carotid Stent 10/02/2006 5022 R1000CP 07/19/2006 Common Working File (CWF) to the Medicare Beneficiary Database (MDB) Data Exchange Changes 10/02/2006 4300 R992CP 06/23/2006 Lumbar Artificial Disc Replacement (LADR) 07/17/2006 5057 R986CP 06/16/2006 Payment for Islet Cell Transplantation in NIH -Sponsored Clinical Trials 07/31/2006 5140 R951CP 05/12/2006 Payment for Carotid Artery Stenting (CAS) Post-Approval Extension Studies 06/12/2006 5088 R931CP 04/28/2006 Billing Requirements for Bariatric Surgery for Treatment of Morbid Obesity 05/30/2006 5013 R911CP 04/21/2006 Clarification on Billing Requirements for Percutaneous Transluminal Angioplasty (PTA) 10/02/2006 5022 Rev # Issue Date Subject Impl Date CR# Concurrent With the Placement of an Investigational or FDA -Approved Carotid Stent R909CP 04/21/2006 Cardiac Rehabilitation Programs 06/21/2006 4401 R908CP 04/21/2006 Common Working File (CWF) to the Medicare Beneficiary Database (MBD) Data Exchange Changes 10/02/2006 4300 R898CP 03/31/2006 External Counterpulsation (ECP) Therapy N/A 4350 R816CP 01/20/2006 Coverage and Billing for Ultrasound Stimulation for Nonunion Fracture Healing 04/03/2006 4085 R801CP 12/30/2005 Instructions for Reporting New HCPCS Code V2788 for Presbyopia- Correcting Intraocular Lenses (P -C IOLs) 01/03/2006 4184 R795CP 12/30/2005 Redefined Type of Bill (TOB) 14X for Non -Patient Laboratory Specimens -CR 3835 Manualization 04/03/2006 4208 R766CP 12/02/2005 Stem Cell Transportation 01/03/2006 4173 R726CP 10/21/2005 Smoking and Tobacco -Use Cessation Counseling Services: Common Working File (CWF) Inquiry for Providers 01/24/2006 4104 R671CP 09/09/2005 Updated Manual Instructions for the Medicare Claims Processing Manual, Regarding Smoking and Tobacco-Use Cessation Counseling Services 10/03/2005 4045 R605CP 07/15/2005 Frequency Instructions for Smoking and Tobacco -Use Cessation Counseling Services 10/03/2005 3929 R601CP 07/01/2005 Cochlear Implantation 07/25/2005 3796 R597CP 06/24/2005 Coverage and Billing for Ultrasound Stimulation for Nonunion Fracture Healing 08/01/2005 3836 R589CP 06/24/2005 Cochlear Implantation 07/05/2005 3796 R562CP 05/20/2005 Smoking and Tobacco -Use Cessation Counseling Services 07/05/2005 3834 R526CP 04/15/2005 Updated Requirements for Autologous Stem Cell Transplantation (AuSCT) 05/16/2005 3797 R498CP 03/11/2005 Billing of the Diagnosis and Treatment of Peripheral Neuropathy with Loss of Protective Sensation in People with Diabetes N/A 3580 R487CP 03/04/2005 Manualization of Claims Processing Instructions for Medicare Qualifying Clinical Trials N/A 3625 Rev # Issue Date Subject Impl Date CR# R486CP 03/04/2005 Manualization of Carrier Claims Processing Instructions for Stem Cell Transplantation N/A 3684 R371CP 11/19/2004 Updated Billing Instructions for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) 04/04/2005 3487 R261CP 07/30/2004 Billing Requirements for Islet Cell Transplantation for Beneficiaries in a National Institutes of Health Sponsored Clinical Trial 10/04/2004 3385 R216CP 06/25/2004 Manualization of Instructions for of INR Monitoring N/A 2323 R187CP 05/28/2004 Manualization of Instructions for Billing for Hyberbaric Oxygen Therapy for the Treatment of Wounds of the Lower Extremities 06/28/2004 3172 R130aCP 03/26/2004 Manualization of Instructions for INR Monitoring N/A 2323 R128CP 03/26/2004 Manualization of Instructions for Deep Brain Stimulation N/A 2553 R125CP 03/26/2004 Manualization of Instructions for Sacral Nerve Stimulation N/A 2532 R124CP 03/19/2004 Policy and Claims Processing Instructions for Electrical Stimulation And Electromagnetic Therapy 07/06/2004 3149 R109CP 02/27/2004 Updated Policy and Claims Processing Instructions for Ambulatory Blood Pressure Monitoring (AMPM) 04/05/2004 2726 Back to top of chapter

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Medicare Claims Processing Manual Chapter 34 - Reopening and Revision of Claim Determinations and Decisions (Rev. 4219, 01-25-19) Table of Contents Transmittals for Chapter 34 10 - Reopenings and Revisions of Claim Determinations and Decisions - General 10.1 - Authority to Conduct a Reopening 10.2 - Refusal to Reopen is Not an Initial Determination 10.3 - Reopening of Denials Based on an Unanswered ADR Request 10.4 - Reopenings Based on Clerical or Minor Errors and Omissions 10.4.1 - Providers Submitting Adjustments 10.5 - Telephone Reopenings Required for A/B MACs (B) Only 10.5.1 - Informing the Provider Communities About the Telephone Reopenings Process 10.5.2 - Issues for Telephone Reopenings 10.5.3 - Conducting the Telephone Reopening 10.5.4 - Documenting the Telephone Reopening 10.5.5 Monitoring the Telephone Reopening 10.6 - Timeframes to Reopen Claim Determinations 10.6.1 - Timeframes for Contractor Initiated Reopenings 10.6.2 - Timeframes for Party Requested Reopenings 10.6.3 - Timeframes for Adjudicator to Reopen 10.6.4 - Timeframes When a Party Requests an Adjudicator Reopen Their Decision 10.7 - Timeframes to Complete a Reopening Request by a Party 10.8 - Notice of a Revised Determination or Decision 10.9 - Revised Determination or Decision 10.10 - Effect of a Revised Determination or Decision 10.11 - Good Cause for Reopening 10.11.1 - What Constitutes New and Material Evidence 10.11.2 Policies Related to Good Cause Reopenings for New and Material Evidence 10.11.3 What Constitutes Error on the Face of the Evidence 10.12 - Change in Substantive Law or Interpretative Policy 10.13 System and Processing Requirements for Use of Secure Internet Portal/Application to Support Reopening Activities 10 - Reopenings and Revisions of Claims Determinations and Decisions - General (Rev. 3568, Issued: 07- 29-16, Effective: 09- 30-16, Implementation: 09- 30-16) A reopening is a remedial action taken to change a binding determination or decision that resulted in either an ov erpayment or an underpayment, even though the determination or decision was correct based on the evidence of record. Reopenings are separate and distinct from the appeals process. Reopenings are a discretionary action on the part of the contractor. A co ntractors decision to reopen a claim determination is not an initial determination and is therefore not appealable. Requesting a reopening does not toll the timeframe to request an appeal. If the reopening action results in a revised determination, then new appeal rights would be offered on that revised determination. Under certain circumstances a party may request a reopening even if the timeframe to request an appeal has not expired. Historically, contractors have employed a variety of informal proce dures under the general heading of reopenings, re- reviews, informal redeterminations, etc. Providers, physicians and suppliers may have come to view these as appeal rights. However, as stated above, reopenings are separate and distinct from the appe als process. They are not a partys right. Contractors shall not use them to provide an appeal when a formal appeal is not available. Contractors should also note that while clerical errors must be processed as reopenings, all decisions on granting reopenings are at the discretion of the contractor. Contractors may conduct a reopening to revise an initial determination or redetermination. Medicare Secondary Payer (MSP) recovery claims where the debtor is the beneficiary or provider/supplier are not reopening actions except where the recovery claim is a MSP provider/supplier recovery claim because the provider/supplier failed to file a proper claim as defined in 42 CFR Part 411 . Aside from this one exception, MSP recovery claims involve recovery of the insurance funds at issue, not recovery of the payment previously made by Medicare. Consequently, the recovery action does not involve the reopening of Medicare's payment determinati on. The MSP recovery demand letter is an "initial determination" as defined in 42 CFR 405.924 , not a reopening and revision of Medicare's initial claims payment determination. 10.1 - Authority to Conduct a Reopening (Rev. 3568, Issued: 07- 29-16, Effective: 09- 30-16, Implementation: 09- 30-16) Reopenings can be conducted by a contractor to revise an initial determination, revised initial determination or redetermination; a Qualified Independent Contractor (QIC) to revise a reconsideration; an Administrative Law Judge (ALJ) to revise a hearing decision, and the Appeals Council (AC) to revise an ALJ decision or their own review decision. Reopenings are generally not conducted until a partys appeal rights have been exhausted or the timeframe to file a request for an appeal has expired. There are two exceptions that allow a reopening to be conducted when appeal rights have not been exhausted or the timeframe to request an appeal has not expired. These exceptions are: Cases where Medical Review (MR) requested documentation, did not receive it, and issued a denial based on no documentation (i.e., Gro up Code: CO - Contractual Obligation; Claim Adjustment Reason Code (CARC) 50 - these are non-covered services because this is not deemed a medical necessity by the payer; and Remittance Advice Remark Code (RARC) M127 - Missing patient medical record for this service ). Subsequently, if the party requests an appeal and submits the requested documentation with that appeal, it shall be treated as a reopening; and Clerical errors (which includes minor errors and omissions) shall be treated as reopenings. If a contractor receives a valid and timely request for redetermination and begins processing the request as a reopening (clerical error or otherwise) and later determines that a reopening cannot be performed, or the determination cannot be changed, the contractor shall not issue a refusal to reopen notice. Rather, the contractor shall process the request as a valid/timely redetermination (as originally requested by the party) in accordance with Pub. 100- 04, chapter 29. If a party has filed a valid request for an appeal, the adjudicator at the lower levels of the appeals process loses jurisdiction to reopen the claim on the issues in question. For example, a party simultaneously requests a QIC reconsideration and a reopening with the contractor. The contr actor can no longer reopen that redetermination decision now that the party has filed a valid request for QIC reconsideration. This does not preclude contractors from accepting and processing remands from the QIC. As stated previously, it is within the contractors discretion to accept reopening requests, but once accepted, they must be processed in accordance with the above instruction. 10.2 - Refusal to Reopen Is Not an Initial Determination (Rev. 1069, Issued: 09- 29-06, Effective: 11- 29-06, Implement ation: 11- 29-06) A finding that a prior determination or decision will not be reopened is not an initial determination or decision. A contractors choice not to reopen is not appealable. Accordingly, the contractor shall not include a statement concerning the right to an appeal in the notice informing the party that their reopening request cannot be processed. A party may however request an appeal on the original claim denial, but must do so within the required timeframes. If a contractor recei ves a reopening request and does not believe they can change the determination, they should not process the request. 10.3 - Reopenings of Denials Based on an Unanswered Additional Documentation Request (ADR) (Rev. 1069, Issued: 09- 29-06, Effective: 11- 29-06, Implementation: 11- 29-06) If a claim is suspended for medical review, an ADR may be issued to obtain information needed to make a determination. Providers, physicians, and suppliers are responsible for providing the information needed to adjudicate t heir claims. If no response is received to the ADR within the specified timeframes, the medical review department will likely deny the service as not reasonable and necessary based on a lack of documentation. If such a denial is appealed, the Medical Rev iew department at the contractor shall perform a reopening instead of an appeal if all of the following conditions are met: 1) A provider failed to timely submit documentation requested through an ADR; 2) The claim was denied because the requested documentatio n was not received timely; 3) The requested documentation is received after the 45 day period with or without a request for redetermination or reopening; AND, 4) The request is filed within 120 days of the date of receipt of the initial determination. If all 4 criteria are not present, the request is for a redetermination and it is submitted within 120 days of the date of receipt of the initial determination, handle it as an appeal and do not ship the case back to MR. In this instance, the request must meet t he criteria for a valid request for redetermination (see Pub. 100- 04, Chapter 29, 310.1) in order for the appeals unit to accept the request. The CMS is handling these requests outside of the appeals process because CMS wants to encourage providers, physicians and suppliers to submit documentation when requested in order to prevent unnecessary appeals. Contractors should note that this requirement does not extend the time frame for filing an appeal. Therefore, only those appeal requests that are sub mitted within 120 days of the date of receipt of the initial determination and meet all of the criteria above should be shipped back to MR for a reopening. When the appeals unit ships cases back to the MR unit, MR must reopen those cases. If the request is submitted after 120 days, contractors may grant a regular reopening at their discretion or dismiss the request if no good cause explanation is provided for the late filing. If the ADR reopening results in an affirmation of the original denial or an adverse decision, the provider will retain their right to a redetermination. The date of the MR decision will be the date used to calculate the 120 days to request a redetermination. 10.4 - Reopenings Based on Clerical or Minor Errors and Omissions (Rev. 3568, Issued: 07- 29-16, Effective: 09- 30-16, Implementation: 09- 30-16) Section 937 of the Medicare Modernization Act (MMA) required CMS to establish a process, separate from appeals, whereby providers, physicians and suppliers could correct minor errors or omissions. We equate the MMAs minor error or omission to fall under our definition of clerical error, located in 42 CFR 405.980(a)(3) . We believe that it is neither cost efficient nor necessary for contractors to correct clerical errors through the appeal process. Thus, 42 CFR 405.927 and 405.980(a)(3) require that clerical errors be processed as reopenings rather than appeals. CMS defines clerical errors (including minor errors or omissions) as human or mechanical errors on the part of the party or the contractor, such as: Mathematical or computational mistakes; Transposed procedure or diagnostic codes; Inaccurate data entry; Misapplication of a fee schedule; Computer errors; or, Denial of claims as duplicates which the party believes were incorrectly identified as a duplicate. Incorrect data items, such as provider number, use of a modifier or date of service. Note that clerical errors or minor errors are limited to errors in form and content, and that omissions do not include failur e to bill for certain items or services. A contractor shall not grant a reopening to add items or services that were not previously billed, with the exception of a few limited items that cannot be filed on a claim alone (e.g., G0369, G0370, G0371 and G037 4). Third party payer errors do not constitute clerical errors. The law provides that reopenings may be done to correct minor errors or omissions, that is, clerical errors. The contractor has discretion in determining what meets this definition and ther efore, what could be corrected through a reopening. 10.4.1 - Providers Submitting Adjustments (Rev. 1069, Issued: 09- 29-06, Effective: 11- 29-06, Implementation: 11- 29-06)

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Transposed procedure or diagnostic codes; Inaccurate data entry; Misapplication of a fee schedule; Computer errors; or, Denial of claims as duplicates which the party believes were incorrectly identified as a duplicate. Incorrect data items, such as provider number, use of a modifier or date of service. Note that clerical errors or minor errors are limited to errors in form and content, and that omissions do not include failur e to bill for certain items or services. A contractor shall not grant a reopening to add items or services that were not previously billed, with the exception of a few limited items that cannot be filed on a claim alone (e.g., G0369, G0370, G0371 and G037 4). Third party payer errors do not constitute clerical errors. The law provides that reopenings may be done to correct minor errors or omissions, that is, clerical errors. The contractor has discretion in determining what meets this definition and ther efore, what could be corrected through a reopening. 10.4.1 - Providers Submitting Adjustments (Rev. 1069, Issued: 09- 29-06, Effective: 11- 29-06, Implementation: 11- 29-06) Part A providers that are able to submit an adjusted or corrected claim to correct an error or omission may continue to do so and are not required to request a reopening. Additionally, we encourage A/B MACs (A) and (HHH) who were handling the corrections of such errors by advising providers to submit adjusted claims to instruct provider s that submitting adjusted claims continues to be the most efficient way to correct simple errors. 10.5 - Telephone Reopenings - Required for A /B MACs (B) Only (Rev. 3568, Issued: 07- 29-16, Effective: 09- 30-16, Implementation: 09- 30-16) NOTE: Since most A/B MACs (A) and (HHH) never processed telephone redeterminations, CMS does not expect that A/B MACs (A) and (HHH) will process many telephone reopenings, if any. However, they are not precluded from doing so, should the telephone process prove effective. If A/B MACs (A) and (HHH) choose to process telephone reopenings, they will be held to the same standards. The majority of appeals processed as telephone redeterminations consisted of minor or clerical errors that could be quickly corrected o ver the telephone. Section 937 of MMA required CMS to establish a process to correct such errors outside of the appeals process. Therefore, CMS has discontinued telephone redeterminations that were formerly processed by A/B MACs (B) and DME MACs and has implemented the telephone reopenings process. CMS believes that the vast majority of the work processed as telephone redeterminations can instead be processed as telephone reopenings. A small percentage of the work processed under telephone redeterminati ons will now fall under written redeterminations and stay within the purview of the appeals units. A/B MACs (B) and DME MACs shall allocate costs of reopenings that would have formerly been processed as a telephone redetermination, but fall under the defi nition of a clerical error under the claims reopenings Budget & Performance Requirements (BPR) Code (11210). ADR reopenings that are shipped back to MR should be counted in the appropriate MR BPR code. The following sections describe the procedures for accepting and processing reopenings over the telephone. CMS believes that most telephone reopenings will consist of clerical errors or omissions that can be corrected quickly and easily over the telephone. That does not preclude contractors from processin g written requests for clerical error reopenings. They may handle such requests either by phone or in writing. Whether a request for reopening is made by telephone or is conducted and completed as a telephone reopening depends on the issues at hand and the complexity of the matters involved. Receiving reopening requests and conducting reopenings on the telephone should expedite and simplify the process. Requesting a reopening on the telephone provides quick and easy access to parties who wish to correc t clerical errors or omissions. The contractor shall ensure that the Privacy Act of 1974, 5 USC, 552a , is applied to its telephone reopening process. All staff that perform telephone reopenings shall be trained on the Privacy Act requirements (see Pub. 100- 01, chapter 6, Disclosure of Information). 10.5.1 - Informing the Provider Communities About the Telephone Reopeni ngs Process (Rev. 3568, Issued: 07- 29-16, Effective: 09- 30-16, Implementation: 09- 30-16) The contractor shall inform providers, physicians, and other suppliers of its telephone reopenings process 30 days prior to initiation and annually thereafter or when making significant changes to its process. It shall provide information about its process through means such as Web sites, bulletins/newsletters, customer service/inquiry and provider relations departments, conduct seminars, etc. Information it publishe s about its telephone reopenings process should include: How to access the process (telephone number, hours of operation, etc.); Any limitations (such as certain issues, number of claims/issues per call, etc.); Specific instructions that the party should state that he/she is requesting a telephone reopening; Type of documentation that the party should have on hand when calling in to request a reopening; The types of issues the contractor might be able to handle over the telephone and the types of issues it will not handle over the telephone. Please see 10.5.2 below for further discussion of issues that are appropriate for telephone reopenings. 10.5.2 - Issues for Telephone Reopenings (Rev. 1069, Issued: 09- 29-06, Effective: 11- 29-06, Implementation: 11- 29-06) Telephone reopenings shall be limited to resolving minor issues and correcting errors as defined in 10.4. As necessary, the contractor may ask the provider, physician, or supplier to fax in documentation to support changes and error correction. If it appears extensive documentation is required for review, please inform the requestor that they should file a written request for reopening or file a request for an appeal, if applicable. Telephone reopenings are generally inappropriate for the following issues: Limitation on liability; Medical necessity denials and reductions; or Analysis of documents such as operative reports and clinical summar ies. Contractors are not precluded from conducting a reopening on the issues listed above. However, CMS believes that the issues above are usually too complex to be handled appropriately over the phone in most instances. In all cases, telephone reopenings are inappropriate for the following issues: Claims requiring the input of medical staff or other entities outside of the reopenings department and big box cases. A. Issues That Can Not be Resolved During the Telephone Reopening There may be instances where an issue cannot be resolved during the telephone reopening. An issue may not be resolvable on the telephone because: (1) the issue becomes too complex to be handled over the telephone and/or it is in the best interest of the party to have a more in -depth review performed; or (2) there is a need for additional medical documentation from the provider, physician, or other supplier. If the issue cannot be resolved due to one of the preceding reasons, the contractor advises the party that the r eopening cannot be handled over the telephone. The contractor shall instruct the party to either file a written request for reopening or file a written request for appeal. Instruct the party that appeal requests must be filed within 120 days from the date of the initial determination. 10.5.3 - Conducting the Telephone Reopening (Rev. 4219, Issued: 01- 25-19, Effective: 02- 26-19, Implementation: 02- 26-19) The term Medicare beneficiary identifier (Mbi) is a general term describing a beneficiary's Medicare identification number. For purposes of this manual, Medicare beneficiary identifier references both the Health Insurance Claim Number (HICN) and the Medicare Beneficiary Identifier (MBI) during the new Medicare card transition period and after for certain business areas that will continue to use the HICN as part of their processes. Prior to conducting a telephone reopening, the caller must provide the following three items: Verify the providers/physicians/suppliers name and identification number or National Supplier Clearinghouse number; Beneficiary last name, first initial; and Medicare number . Items must match exactly. The contractor should also inform the caller that the call may be monitored for quality assurance. The following items shall be obtained/recorded/confirmed during telephone reopening: Date of call; Name of caller; Phone number of the party; Name of provider/physician/supplier of item or service; Dates of service; Which items(s) or service(s) are at issue; Reason for the request; Any new information that is received during the telephone call; Rationale for not processing the request, if applicable; Any appeal rights, if applicable ; Name of the reviewer; Confirmation number, if applicable; and Inform the caller that the call may be monitored. 10.5.4 - Documenting the Telephone Reopening (Rev. 1069, Issued: 09- 29-06, Effective: 11- 29-06, Implementation: 11- 29-06) The information received during the telephone reopening (especially the date of the call) must be either: (1) documented on a reopening documentation form; or (2) logged into the contractors computer system. All documentation must be assigned a control number. Any additional documentation received must be recorded into the contractor system or attached to th e form. The telephone reopening control number is recorded on all documents received that are associated with the telephone reopening, if applicable. The documents are included in the file. Although documentation should rarely be necessary during a tele phone reopening, the documentation must be made a part of the file and be available if an appeal is requested based on any revised determination issued as a result of the reopening. All documentation should be maintained in a manner that allows for future audits. 10.5.5 - Monitoring the Telephone Reopening (Rev. 3568, Issued: 07- 29-16, Effective: 09- 30-16, Implementation: 09- 30-16) CMS may review this function at any time so the contractor may want to develop and maintain records on a monitoring/quality assurance process. 10.6 - Timeframes to Reopen Claim Determinations (Rev. 3568, Issued: 07- 29-16, Effective: 09- 30-16, Implementation: 09- 30-16) Our regulations establish timeframes that restrict the ability of the contractor to reopen claim determinations. See 42 CFR 405.980(b) and (c) for the timeframes for reopenings. The specific timeframes for contractor -initiated and party -requested reopenings are detailed below. 10.6.1 - Timeframes for Contractor Initiated Reopenings (Rev. 3568, Issued: 07- 29-16, Effective: 09 -30-16, Implementation: 09- 30-16) A contractor may reopen and revise its initial determination or redetermination on its own motion: Within 1 year from the date of the initial determination or redetermination for any reason; or Within 4 yea rs from the date of the initial determination or redetermination for good cause as defined in 10.11; or At any time if: o There exists reliable evidence that the initial determination was procured by fraud or similar fault as defined in 42 CFR 405.902 ; or o The initial determination is unfavorable, in whole or in part, to the party thereto, but only for the purpose of correcting a clerical error on which that determination was based. Third party payer error does not constitute clerical error as defined in 10.4; or, At any time to effectuate a coverage decision issued under 42 CFR 426.460(b)(1)(i) , 426.488(b) and (c) or 426.560 (b)(1)(i) appeals process. 10.6.2 - Timeframes for Party Requested Reopenings (Rev. 3568, Issued: 07- 29-16, Effective: 09- 30-16, Implementation: 09- 30-16) A party may request a contractor reopen and revise its initial determination or redetermination under the following conditions:

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Within 1 year from the date of the initial determination or redetermination for any reason; or Within 4 yea rs from the date of the initial determination or redetermination for good cause as defined in 10.11; or At any time if: o There exists reliable evidence that the initial determination was procured by fraud or similar fault as defined in 42 CFR 405.902 ; or o The initial determination is unfavorable, in whole or in part, to the party thereto, but only for the purpose of correcting a clerical error on which that determination was based. Third party payer error does not constitute clerical error as defined in 10.4; or, At any time to effectuate a coverage decision issued under 42 CFR 426.460(b)(1)(i) , 426.488(b) and (c) or 426.560 (b)(1)(i) appeals process. 10.6.2 - Timeframes for Party Requested Reopenings (Rev. 3568, Issued: 07- 29-16, Effective: 09- 30-16, Implementation: 09- 30-16) A party may request a contractor reopen and revise its initial determination or redetermination under the following conditions: With in 1 year from the date of the initial determination or redetermination for any reason; or Within 4 years from the date of the initial determination or redetermination for good cause as defined in 10.11; or, At any time if the initial determination is u nfavorable, in whole or in part, to the party thereto, but only for the purpose of correcting a clerical error on which that determination was based. Third party payer error does not constitute clerical error as defined in 10.4. While a contractor can r eopen at any time under the limited criterion set forth above to correct an unfavorable determination, CMS does not expect that a contractor would regularly grant these requests, especially for older claims where the claims history is not readily available. Both the contractor and the provider/physician/supplier have a reasonable expectation to administrative finality in the processing of their claims. Additionally, administrative efficiency and the ability of a Medicare contractor to continue vital funct ions (i.e., process Medicare claims and process appeal requests) require that contractors grant such requests rarely. 10.6.3 - Timeframes for Adjudicator to Reopen (Rev. 3568, Issued: 07- 29-16, Effective: 09- 30-16, Implementation: 09- 30-16)A QIC, ALJ or the AC may reopen and revise its reconsideration, hearing decision or review, respectively, under the following conditions: Within 180 days from the date of its decision for good cause in accordance with 42 CFR 405.986 ; or, At any time if the reconsideration, hearing decision or review was procured by fraud or simi lar fault. 10.6.4 - Timeframes When a Party Requests an Adjudicator Reopen Their Decisions (Rev. 3568, Issued: 07- 29-16, Effective: 09- 30-16, Implementation: 09- 30-16) A party may request a QIC, ALJ or the AC reopen and revise its reconsideration, hearin g decision or review within 180 days from the date of the reconsideration, hearing decision or review, as applicable, for good cause in accordance with 42 CFR 405.986 . 10.7 - Timeframes to Complete a Reopening Requested by a Party (Rev. 2241; Issued: 06- 17-11, Effective: 10- 01-11, Implementation: 10- 03-11) There are no timeframes established in statute or regulati on governing the timeframes for a contractor to complete a reopening action. However, a party to an initial determination has a reasonable expectation to the administrative finality of a determination issued by Medicare. Therefore, this section sets out timeframes to complete the reopening action once the reopening has been initiated. These timeframes apply only to those reopening requests that are requested by the party to the initial determination. These timeframes do not apply to contractor initiated reopenings. For those reopenings requested by a party that the contractor agrees to reopen, the contractor shall complete the reopening action 60 days from the date of receipt of the partys reopening request in the corporate mailroom, receipt in a secur e Internet portal/application, or receipt of the telephone request. This does not apply to big box cases defined as aggregated requests filed by a provider, physician, or other supplier that involve 40 or more beneficiaries/claims and $40,000 or more i n controversy. 10.8 - Notice of a Revised Determination or Decision (Rev. 2241; Issued: 06- 17-11, Effective: 10- 01-11, Implementation: 10- 03-11) If the reopening action results in a revised determination or decision that results in payment to a provider, physician, or supplier, a revised electronic or paper remittance advice notice must be issued by the Medicare contractor and will satisfy the notice requirements. If applicable, a revised Medicare Summary Notice will suffice for notice to the beneficiary in the above instances. If the reopening action results in an adverse revised determination or decision the contractor shall mail, or if approved by CMS, transmit via a secure Internet portal/application a letter that states the rationale and basis for the reopening and revision and any right to appeal. The timeframe to request the appeal would be based on the date of the contractors revised determination. If the contractor cannot change the original determination or chooses to not accept the request, the contractor should inform the requestor that the contractor cannot process their reopening request. If the request is over the telephone, the contractor can verbally inform the caller that they cannot process their request. If it is a written reopenin g request submitted via hard copy or a secure Internet portal/application, the contractor shall send a brief letter via mail or, if approved by CMS, a secure Internet portal/application, informing the requestor that they cannot process the request. The contractor should state that their decision to not reopen a claim determination is not an initial determination and is therefore not appealable. 10.9 - Revised Determination or Decision (Rev. 1069, Issued: 09- 29-06, Effective: 11- 29-06, Implementation: 11- 29-06) A revised determination or decision is one in which: The end result is changed (e.g., a service previously found to be covered is now found not to be covered or the allowable charge for the service is determined to be incorrect); or The end r esult is not changed, but a party might be disadvantaged by the revision (e.g., a request for payment on a claim previously disallowed because the services were not medically necessary and therefore subject to the limitation on liability provisions, is now to be disallowed on a basis that precludes consideration of limitation on liability). 10.10 - Effect of a Revised Determination or Decision (Rev. 1069, Issued: 09- 29-06, Effective: 11- 29-06, Implementation: 11- 29-06) The revision of an initial determina tion is binding on all parties unless a party files a written request for a redetermination of the revised determination that is accepted and processed. The request for a redetermination must be filed within 120 days from the date of the revised initial d etermination. The revision of a redetermination is binding on all parties unless a party files a written request for a QIC reconsideration that is accepted and processed. 10.11 - Good Cause for Reopening (Rev. 3568, Issued: 07- 29-16, Effective: 09- 30-16, Implementation: 09 -30-16) On its own initiative or at the request of party (see IOM Pub. 100- 04, chapter 29, 110 for the definition of a party), a contractor may reopen an initial determination or redetermination within 4 years from the date of the initial determination or redetermination when good cause exists. However, good cause is not required for reopening of claims for up to 1 year from the date of the initial determination or redetermination. Under 42 CFR 405.986 , good cause exists when: There is new and material evidence that was not available or known at the time of the determination or decision and may result in a different conclusion; or The evidence that was considered in making the determination or decision clearly shows on its face that an obvious error was made at the time of the determination or decision. A contractors decision to reopen based on the existence of good cause, or refusal to reopen after determining good cause does not exist, is not subject to appeal. See 42 CFR 405.926(l) , and 405.980(a)(5) . NOTE: Third par ty payer error in making a primary payment determination does not constitute good cause for the purposes of reopening an initial determination or redetermination when Medicare processed the claim in accordance with the information in its system of records or on the claim form. Contractors may only reopen for third party payer error under the within one year for any reason standard. This is true for both contractor initiated reopenings as well as reopenings requested by a party. All providers and suppli ers have a legal obligation to determine the correct primary payer when billing Medicare. Failure to do so, regardless of third party payer error, does not constitute good cause that will permit reopening beyond one year. Information regarding such error does not constitute new and material evidence. 10.11.1 - What Constitutes New and Material Evidence (Rev. 1671, Issued: 01- 16-09; Effective/Implementation Date: 02 -16-09) New and material evidence is one of the means for establishing good cause to reopen an initial determination or redetermination. New and material evidence is evidence that: 1. Was not readily available or known to the person or entity requesting/initiating the reopening at the time of the initial determination or redetermination ; and 2. May result in a conclusion different from that reached in the initial determination or redetermination. For example, data analysis that identifies a high error rate or pattern of potential overutilization on the part of a provider or supplier is one example of evidence that is not readily available or known to a contractor at the time it made its initial determination, and may cause the contractor to believe its initial determinations for the claims of the provider or supplier were incorrect. Evidence may include any record used in the provision of medical care that supports whether or not the service was covered, medically necessary, and provided as billed. This includes medical records, progress notes, orders, procedure reports, invoices, pr oofs of delivery, or other documentation as required by CMS policy. However, as explained further below, any such evidence submitted by a party must satisfy the good cause standard set forth in 405.986 (i.e., that it is new and material evidence (as desc ribed above), or demonstrates that the evidence considered in making the initial determination or redetermination clearly shows on its face that an obvious error was made at the time of the determination or decision). 10.11.2 - Policies Related to Good Cause Reopenings for New and Material Evidence (Rev. 1671, Issued: 01- 16-09; Effective/Implementation Date: 02 -16-09) In determining whether good cause exists for reopening an initial determination or redetermination, the contractor considers whether evidence is new and material from the perspective of the person or entity requesting or initiating the reopening. When a party requests a reopening of an initial determination or redetermination for good cause based on the submission of new and material e vidence, the following policies apply: The mere submission of additional evidence is not necessarily sufficient to establish good cause to reopen an initial determination or decision. The information must be new, (i.e., not readily available or known t o exist at the time of the initial determination) as well as material (i.e., may result in a different conclusion). A party should explain how the information constitutes new and material evidence that establishes good cause. If the contractor is unable to determine whether the information submitted with a reopening request constitutes new and material evidence, the contractor may decide not to grant the reopening. When a request for reopening is submitted with new and material evidence, but additional i nformation or evidence is needed before a proper revised determination or decision can be made, the contractor may contact the party seeking the reopening, and request that they obtain and submit the additional information. If the person or entity request ing the reopening cannot obtain the additional information, the Medicare contractor assists to the extent that it is reasonably able to do so.

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When a party requests a reopening of an initial determination or redetermination for good cause based on the submission of new and material e vidence, the following policies apply: The mere submission of additional evidence is not necessarily sufficient to establish good cause to reopen an initial determination or decision. The information must be new, (i.e., not readily available or known t o exist at the time of the initial determination) as well as material (i.e., may result in a different conclusion). A party should explain how the information constitutes new and material evidence that establishes good cause. If the contractor is unable to determine whether the information submitted with a reopening request constitutes new and material evidence, the contractor may decide not to grant the reopening. When a request for reopening is submitted with new and material evidence, but additional i nformation or evidence is needed before a proper revised determination or decision can be made, the contractor may contact the party seeking the reopening, and request that they obtain and submit the additional information. If the person or entity request ing the reopening cannot obtain the additional information, the Medicare contractor assists to the extent that it is reasonably able to do so. When a Medicare contractor initiates a reopening of an initial determination or redetermination for good cause based on the existence of new and material evidence, the following policies apply: The contractor is responsible for clearly documenting in the case file the new and material evidence that represents good cause for reopening. In order to promote administrative efficiency, Medicare does not generally require that a party submit supporting medical documentation with the initial claim. Therefore, if a medical record or other supporting documentation was not utilized when a contractor made an initial determination, because it was not requested or was not provided, then the content of any medical records or supporting documentation which are subsequently requested by the contractor during the course of its review would constitute new evidence. 10.11.3 - What Constitutes Error on the Face of the Evidence (Rev. 1671, Issued: 01- 16-09; Effective/Implementation Date: 02 -16-09) Error on the face of the evidence exists if it is clear that the determination or decision was incorrect based on all evidence i n file on which the determination or decision was based, or any evidence of record anywhere in the contractors Medicare file or in CMS files at the time such determination or decision was made. 10.12 - Change in Substantive Law or Interpretative Policy (Rev. 3568, Issued: 07- 29-16, Effective: 09- 30-16, Implementation: 09- 30-16) A change of legal interpretation or policy by CMS in a regulation, CMS ruling or CMS general instruction, or a change in legal interpretation or policy by SSA in a regulation, SSA ruling or SSA general instruction in entitlement appeals, whether made in response to judicial precedent or otherwise, is not a basis for reopening a determination or decision under this section. This provision does not preclude contractors from conducti ng reopenings to effectuate coverage decisions issued under 42 CFR 42 CFR 426.460(b)(1)(i) , 426.488 (b) and (c) , or 426.560(b)(1)(i) appeals process.. 10.13 System and Processing Requirements for Use of Secure Internet Portal/Application to Support Reopening Activities (Rev. 2241; Issued: 06- 17-11, Effective: 10- 01-11, Implementation: 10 -03-11) Contractors who develop and utilize a secure Internet portal/application for reopening purposes shall ensure, at a minimum: CMS approves (i.e., Contract Manager or Project Officer, if applicable, and Appeals Business Function Lead) the proposed portal/application and usage prior to development and implementation. The portal/application fully complies and has been tested to ensure compliance with all CMS system security requirements regarding protected health information prior to implementation/usage. The secure Internet portal/application includes a formal registration process that validates the signature. This process shall include, at a minimum, use of restricted user identifiers (IDs) and passwords. Contractors shall include an indication and/or description of the validation methodology in the appeals case file should an appeal on the item/service reopened be requested. Templates for submission of electronic reopening request shall include, at a minimum, a method for authe nticating that the party has completed the portal/application registration process and has been properly identified by the system as an appropriate user. Contractors utilizing an approved portal/application shall provide education to parties to the reopen ing regarding system capabilities/limitations prior to implementation and utilization of the secure portal/application. Contractors shall also educate parties to the reopening that participation/enrollment in the secure portal/application is at the discre tion of the party and the party bears the responsibility for the authenticity of the information being attested to. Appropriate procedures are in place to provide parties with confirmation of receipt of the reopening request via secure Internet/portal and verbiage instructing the parties not to submit additional reopening requests for the same item or service via different venue (hard copy mail or telephone). Contractors utilizing a secure portal/application shall ensure that there is a process in place b y which a party can submit additional documentation/materials concurrent with the reopening request. The portal/application shall have the capability to accept additional documentation and/or other materials to support reopening requests. Refusal to reop en and adverse revised determination notices transmitted via a secure Internet portal/application shall comply with the timeliness and content requirements as outlined in the Pub. 100- 04, chapter 34. In addition, contractors shall provide hard copy decisi on notices to parties to the reopening, as required, who do not have access to the secure Internet portal/application. The notices must be mailed and/or otherwise transmitted concurrently (i.e., mailed on the same day the notice is transmitted via the sec ure portal/application). Contractors utilizing a secure Internet portal/application shall include the adverse revised determination/decision notice and any other related materials in the appeals case file if a valid appeal on the item/service is later req uested. Contractors shall also ensure that parties may save and print the revised adverse determination/decision notice or refusal to reopen notice and that the secure portal/application includes a mechanism by which the date/time of the notification is tracked/marked both in the system and on any printed decision notices so as to adequately inform the party of timeframes for ensuring timely submission of future appeal requests. Transmittals Issued for this Chapter Rev # Issue Date Subject Impl Date CR# R4219CP 01/25/2019 Update to Pub. 100- 04 Chapter 34 to Provide Language -Only Changes for the New Medicare Card Project 02/26/2019 11115 R3568CP 07/29/2016 Reopenings Update - Changes to Chapter 34 09/30/2016 9639 R2241CP 06/17/2011 Guidelines to Allow Contractors to Develop and Utilize Procedures for Accepting and Processing Reopenings Via a Secure Internet Portal/Application 10/03/2011 7420 R1671CP 01/16/2009 Clarification of Requirements for New and Material Evidence as Good Cause for Reopening 02/16/2009 6157 R1069CP 09/29/2006 Initial Release of Chapter -Reopenings and Revisions of Claim Determinations and Decisions 11/29/2006 4147 Back to top of chapter

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Medicare Claims Processing Manual Chapter 35 Independent Diagnostic Testing Facility (IDTF) Table of Contents (Rev. 4473, 12- 06-19) Transmittals for Chapter 35 10 - General Coverage and Payment Policies 10.1 - The Term Independent Diagnostic Testing Facility (IDTF) 10.2 - Claims Processing 10.2.1 Global billing 10.2.2 Separate T echnical and Professional Component Billing 20 - Ordering of Test 30 - Diagnostic Tests Subject to the Anti -Markup Payment Limitation 30.1 - National Provider Identification (NPI) Reported on Claims 40 - Interpretations Performed Off the Premises of the IDTF 50 - Therapeutic Procedures 10 - General Coverage and Payment Policies (Rev. 1506; Issued: 05- 16-08; Effective/Implementation Date: 06 -16-08) Effective for diagnostic procedures performed on or after March 15, 1999, A/B MACs (B) will pay for diagnostic procedures unde r the physician fee schedule only when performed by a physician, a group practice of physicians, an approved supplier of portable x -ray services, a nurse practitioner, or a clinical nurse specialist when he or she performs a test he or she is authorized by the State to perform, or an independent diagnostic testing facility (IDTF). An IDTF may be a fixed location or a mobile entity. It is independent of a physician's office or hospital. Refer to the Medicare Program Integrity Manual, Pub. 100- 08, chapter 10, for information concerning provider enrollment and instructions regarding entities that must enroll as and bill for diagnostic procedures as an independent diagnostic testing facility (IDTF). 10.1 - The Term Independent Diagnostic Testing Facility (ID TF) (Rev. 1506; Issued: 05- 16-08; Effective/Implementation Date: 06 -16-08) Consistent with 42 CFR 410. 33(a)(1), an IDTF is one that is independent both of an attending or consulting physicians office and of a hospital. However, IDTF general coverage and payment policy rules apply when an IDTF furnishes diagnostic procedures in a physicians office. 10.2 - Claims Processing (Rev. 4473, Issued: 12- 6-19; Effective: 3 -9-20; Implementation: 3- 9-20) A. Billing Issues Nothing in this document or in the Medicare Enrollment Application, (CMS -855B) or the Internet -based Provider Enrollment, Chain and Ownership System shall be construed or interpreted to authorize billing by an IDTF, physician, physician group practice, or any other entity that would otherwise violate the physician self -referral prohibition set forth in 1877 of the Social Security Act and related regulations. A/B MACs (Part B) must deny claims submitted in violation of 1877 and demand refunds of any payme nts that have been made in violation of 1877. Consistent with 42 CFR 410.32(a), the supervisory physician for the IDTF, whether or not for a mobile unit, may not order tests to be performed by the IDTF, unless the supervisory physician is the patients t reating physician and is not otherwise prohibited from referring to the IDTF. The supervisory physician is the patients treating physician if he or she furnishes a consultation or treats the patient for a specific medical problem and uses the test result s in the management of the patients medical problem. If an IDTF wants to bill for an interpretation performed by a physician who does not share a practice with the IDTF, the IDTF must meet certain conditions concerning the anti-markup payment limitation. If a physician working for an IDTF (or a party related to the IDTF through common ownership or control as described in 42 CFR 413.17) does not order the technical component or professional component of a diagnostic test (excluding clinical diagnostic la boratory tests), it would not be subject to the anti -markup payment limitation. (See Pub. 100- 04, chapter 1, 30.2.9) B. Transtelephonic and Electronic Monitoring Services Transtelephonic and electronic monitoring services (e.g., 24 hour ambulatory EKG monitoring, pacemaker monitoring and cardiac event detection) may perform some of their services without actually seeing the patient. Most but not all of these billing codes are 93012 ,93014, 93040, 93224, 93225, 93226, 93232, 93230, 93231, 93233, 93236, 93270, 93271, 93731, 93733, 93736, 95953, 95956, These monitoring service entities should be classified as IDTFs and must meet all IDTF requirements. We currently do not have specific certification standards for their technicians; technician credentialing requirements for them are at A/B MAC (Part B) discretion. They do require a supervisory physician who performs General Supervision. Final enrollment of a transtelephonic or electronic monitoring service as an IDTF requires a site visit. For any entity t hat lists and will bill codes 93012, 93014, 93268, 93270, 93271, 93272, the A/B MAC (Part B) must make a written determination that the entity actually has a person available on a 24 hour basis to answer telephone inquiries. Use of an answering service in lieu of the actual person is not acceptable. The person performing the attended monitoring should be listed in Section 3 of Attachment 2 of Form CMS -855B. The qualifications of the person are at the A/B MAC (Part B) s discretion. The A/B MAC (Part B) s hall check that the person is available by attempting to contact the applicant during non- standard business hours. In Particular, at least one of the contact calls should be made between midnight and 6:00 AM. If the applicant does not meet the availabili ty standard they should receive a denial. C. Slide Preparation Facilities and Radiation Therapy Centers Slide Preparation Facilities and Radiation Therapy Centers are not IDTFs. Slide preparation facilities are entities that provide slide preparation serv ices and other kinds of services that are payable through the technical component of the surgical pathology service. These entities do not provide the professional component of surgical pathology services or other kinds of laboratory tests. The services that they provide are recognized by A/B MACs (Part B) for payment, as codes in the surgical pathology code range (88300) to (88399) with a technical component value under the physician fee schedule. The services provided by these entities are usually orde red by and reviewed by a dermatologist. Slide preparation facilities generally only have one or two people performing this service. All enrolled Slide Preparation Facilities must enroll separately with their Medicare contractor. Radiation therapy center s provide therapeutic services and therefore are not IDTFs. Radiation therapy centers must enroll separately with their Medicare contractor. 10.2.1 Global Billing (Rev. 4473, Issued: 12- 6-19; Effective: 3 -9-20; Implementation: 3- 9-20) Global billing is acceptable when both the TC and 26 modifier are performed by the same entity and both the TC and the 26 modifier are furnished within the same Medicare Physician Fee Schedule (MPFS) payment locality. The TC and 26 may be furnished in different locations as long as they are furnished within the same MPFS payment locality. If the global diagnostic test code is billed, report the name, address and NPI of the location where the technical component was furnished in Items 32 and 32a (or the 837P electronic claim equivalent). See Pub. 100- 04, chapter 1, 80.3.2.1.2 and 80.3.2.1.3 for more information regarding what is required in Items 32 and 32a. 10.2.2 Separate Technical and Professional Component Billing (Rev. 4473, Issued: 12- 6-19; Effective: 3 -9-20; Implementation: 3- 9-20) When the TC and 26 modifier are billed separately (not billed globally), report the name, address and NPI of the location where each component was performed. If the billing provider has an enrolled practice location at the address where the service was performed, the billing provider/supplier may report their own name, address and NPI in Items 32 and 32a (or the 837P electronic claim equivalent). If the professional component service was performed at an unusual or infrequently used location, the location of the providers/suppliers closest Medicare -enrolled practice location may be used in Item 32. The NPI in Item 32a must correspond to the entity identified in Item 32 (no matter if it is the group, hospital, t he IDTF, or the individual physician). The only exception for Medicare claims is when a service is performed out of jurisdiction and is subject to the anti-markup or a reference lab service. See Pub. 100- 04, chapter 1, 30.2.9 and chapter 16, 40.1 for i nstructions specific to anti -markup and reference lab, respectively. See, Pub. 100- 04, chapter 1, 80.3.2.1.2 and 80.3.2.1.3 for more information regarding what is required in Items 32 and 32a. 20 - Ordering of Test (Rev. 1506; Issued: 05- 16-08; Effecti ve/Implementation Date: 06 -16-08) All procedures performed by the IDTF must be specifically ordered in writing by the physician or practitioner who is treating the beneficiary, that is, the physician who is furnishing a consultation or treating a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary's specific medical problem. (Nonphysician practitioners may order tests as set forth in CFR 410.32(a)(3).) The order must specify the diagnosis or ot her basis for the testing. The supervising physician for the IDTF may not order tests to be performed by the IDTF, unless the IDTF's supervising physician is in fact the beneficiary's treating physician. That is, the physician in question had a relations hip with the beneficiary prior to the performance of the testing and is treating the beneficiary for a specific medical problem. The IDTF may not add any procedures based on internal protocols without a written order from the treating physician. 30 - Diagnostic Tests Subject to the Anti -Markup Payment Limitation (Rev. 4473, Issued: 12- 6-19; Effective: 3 -9-20; Implementation: 3- 9-20) In most instances, physicians working for an IDTF do not order diagnostic tests because such tests are generally ordered by the patients treating physician. If a physician working for an IDTF does not order a diagnostic test, the test is not subject to the anti -markup payment limitation. However, if a physician working for an IDTF (or a physician financially related to the IDTF through common ownership or control) orders a diagnostic test payable under the Medicare Physician Fee Schedule (MPFS), the anti -markup payment limitation may apply (depending on whether the performing physician or other supplier meets the sharing a practice requirements). For additional information, see Pub. 100- 04, chapter 1, 30.2.9. If a physician working for an IDTF (or a physician financially related to the IDTF through common ownership or control) orders and the IDTF bills for a diagnostic test that is performed by another physician or supplier, the performing physician or other supplier must be enrolled in the Medicare program. No formal reassignment is necessary; however, reassigned diagnostic testing services may also be subject to the a nti-markup payment limitation. The billing entity must report using the ASC X12 837 professional claim format or on the Form CMS -1500 the name, NPI, and address of the performing physician or other supplier. The acquisition price of the either the techni cal component or professional component of the diagnostic test must also be reported on the claim.

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If a physician working for an IDTF (or a physician financially related to the IDTF through common ownership or control) orders and the IDTF bills for a diagnostic test that is performed by another physician or supplier, the performing physician or other supplier must be enrolled in the Medicare program. No formal reassignment is necessary; however, reassigned diagnostic testing services may also be subject to the a nti-markup payment limitation. The billing entity must report using the ASC X12 837 professional claim format or on the Form CMS -1500 the name, NPI, and address of the performing physician or other supplier. The acquisition price of the either the techni cal component or professional component of the diagnostic test must also be reported on the claim. Effective for claims with dates of service on or after January 25, 2005, A/B MACs (Part B) must accept and process claims for diagnostic tests subject to the anti -markup payment limitation billed by suppliers (including laboratories, physicians, and independent diagnostic testing facilities [IDTFs]) enrolled in the A/B MACs (Part B) jurisdiction, for services furnished anywhere in the United States. For s ervices furnished outside the A/B MAC (Part B) jurisdiction in which the billing entity is enrolled, the billing entity must submit its own NPI with the name, address, and ZIP code of the performing physician or other supplier in the appropriate data field. (The billing physician or other supplier should maintain a record of the performing physician or other suppliers NPI in the clinical record for auditing purposes.) Effective April 1, 2005, A/B MACs (Part B) must price claims for diagnostic tests that are subject to the anti -markup payment limitation based on the ZIP Code of the location where the service was rendered, using a CMS -supplied abstract file containing the HCPCS codes that are payable under the MPFS as an anti-markup test for the calendar ye ar. From April 1, 2005, through December 31, 2013, this was done using a CMS- supplied abstract file containing the HCPCS codes that are payable under the MPFS as an anti -markup test for the calendar year. Beginning January 1, 2014, A/B MACs (Part B) began using the Purchased Diagnostic Test Indicator for the HCPCS codes that are payable under the MPFS as an anti -markup test for the calendar year. A/B MACs (Part B) must pay the lesser of: (a) the net acquisition price, (b) the billing entitys actual charg e, or (c) the fee schedule amount as if the test was billed by the performing supplier. Effective for claims submitted with a receipt date on and after October 1, 2015, the billing physician or supplier must report the name, address, and NPI of the perfor ming physician or supplier in Item 32a on anti -markup and reference laboratory claims, even if the performing physician or supplier is enrolled in a different A/B MAC (Part B) jurisdiction. See Pub. 100- 04, Chapter 1, 10.1.1 for more information regarding claims filing jurisdiction. NOTE: As with all services payable under the MPFS, the ZIP Code is used to determine the appropriate payment locality and corresponding fee that is used to price the service that is subject to the anti- markup payment limitation. When a ZIP Code crosses county lines, CMS uses the dominant locality to determine the corresponding fee. 30.1 - National Provider Identification (NPI) Reported on Claims (Rev. 2994; Issued: 07- 25-14; Effective: 01- 01-12; Implementation: 08 -25-14) Effective for dates of service May 23, 2008 and later, IDTFs must submit the NPI assigned to the ordering physician using the ASC X12 837 professional claim format or, for paper claims, on the Form CMS -1500. 40 - Interpretations Performed Off the Premise s of the IDTF (Rev. 1987, Issued: 06- 11-10, Effective: 08- 12-10, Implementation: 08- 12-10) If an IDTF wants to bill for an interpretation performed by an independent practitioner off the premises of the IDTF, the IDTF must meet the conditions shown in IOM Pub. 100-04, Chapter 1, 30.2.9. 50 - Therapeutic Procedures (Rev. 1506; Issued: 05- 16-08; Effective/Implementation Date: 06 -16-08) An IDTF shall not be allowed to bill for any CPT or HCPCS codes that are solely therapeutic. Transmittals Issued for this Chapter Rev # Issue Date Subject Impl Date CR# 12/06/2019 Update to Medicare Claims Processing Manual, Chapters 1, 23 and 35 03/09/2020 10882 R3255CP 05/08/2015 Correction to the Multi -Carrier System (MCS) Editing on the Service Location National Provider Identifier (NPI) Reported for Anti -Markup and Reference Laboratory Claims 10/05/2015 9150 R3103CP 11/03/2014 Reporting the Service Location National Provider Identifier (NPI) on Anti -Markup and Reference Laboratory Claims 04/06/2015 8806 R3098CP 10/21/2014 Reporting the Service Location National Provider Identifier (NPI) on Anti -Markup and Reference Laboratory Claims Rescinded and replaced by Transmittal 3103 04/05/2014 8806 R3047CP 08/22/2014 Reporting the Service Location National Provider Identifier (NPI) on Anti -Markup and Reference Laboratory Claims Rescinded and replaced by Transmittal 3098 01/05/2014 8806 R2994CP 07/25/2014 Update to Pub. 100 -04, Chapter 35 to Provide Language -Only Changes for Updating ASC X12 08/25/2014 8769 R1987CP 06/11/2010 Correction to the Claims Processing Internet Only Manual (IOM) t o Reinstate Previous Instructions Regarding Payment Jurisdiction for Reassigned Services 08/12/2010 6923 R1931CP 03/12/2010 Revision of the Internet Only Manual (IOM) to Remove References to Purchased Diagnostic Test and Replace With Language Consistent With the Anti -Markup Rule 06/14/2010 6627 R1504CP 05/15/2008 New Chapter for Independent Diagnostic Testing Facilities (IDTF) 06/16/2008 5815 Back to top of chapter

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Medicare Claims Processing Manual Chapter 36 Competitive Bidding Table of Contents (Rev. 11427, 05-20-22) Transmittals for Chapter 36 01 - Foreword 10 - Background 10.1 - Competitive Bidding Implementation Contractor (CBIC) 10.2 - Definitions 20 - DMEPOS Competitive Bidding Process 20.1 - Items Subject to Competitive Bidding 20.2 - Competitive Bidding Areas (CBAs) 20.3 - No Administrative or Judicial Review 20.4 - Eligibility Requirements to Submit a Bid 20.5 - Becoming a Contract Supplier 20.5.1 - Small Suppliers and Networks 20.5.2 - Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs) 20.5.3 - Home Health Agencies 20.5.3.1 - Mail -Order Suppliers for Diabetic Supplies 20.5.4 - Items Furnished on a Mail Order Basis 20.5.4.1 - Mail -Order Suppliers for Diabetic Supplies 20.6 - Noncontract Suppliers 20.6.1 - Special Rules for Certain Rented Durable Medical Equipment (DME), Oxygen and Oxygen Equipment (Grandfathered Suppliers and Items) 20.6.1.1 - Requirements for Grandfathered Suppliers 20.6.1.1.1 - Eligibility 20.6.1.1.2 - Servicing Current Beneficiaries 20.6.1.1.3 - Notification to Beneficiaries by Suppliers that Choose to Become Grandfathered Suppliers 20.6.1.1.4 - Notification to Beneficiaries for Suppliers that Choose Not to Become Grandfathered Suppliers 20.6.2 - New Period of Continuous Use 20.6.3 - Picking Up Equipment 20.6.4 - Transfer of Title for Oxygen Equipment and Capped Rental DME 20.6.5 - Capped Rental DME Furnished Prior to January 1, 2006 20.7 - Use of Advanced Beneficiary Notice (ABNs) 30 - Contract Supplier Responsibilities 30.1 - Compliance with Laws and Regulations 30.2 - Requirement to Maintain Medicare Billing Privileges and Accreditation 30.3 - Servicing the Entire Geographic Area of a CBA 30.4 - Prescr iption for Particular Brand, Item, or Mode of Delivery 30.5 - No Discrimination Against Beneficiaries 30.6 - Quarterly Reports 30.7 - Reporting Change of Ownership (CHOW) 30.8 - Submission of Claims 30.9 - Breach of Contract 30.10 - Request for Reconsideration 40 - Payment Rules 40.1 - Single Payment Amount 40.2 - Conditions for Payment 40.3 - Payment for Grandfathered Items Furnished During the Initial Competitive Bidding Contract Period/Program 40.3.1 - Payment Ca tegories 40.3.1.1 - Inexpensive or Routinely Purchased Items 40.3.1.2 - Items Requiring Frequent and Substantial Servicing 40.3.1.3 - Oxygen and Oxygen Equipment 40.3.1.4 - Other DME or Capped Rental Items 40.3.2 - Payment for Grandfathered Items Furnished During Subsequent Competitive Bidding Contract Periods/Programs 40.3.2.1 Pa yment for Capped Rental Items 40.3.2.2 Payment for Inexpensive or Routinely Purchased 40.3.3 - Accessories and Supplies for Grandfathered Items 40.4 - Payment for Rental of Inexpensive or Routinely Purchased DME 40.5 - Payment for Oxygen and Oxygen Equipment 40.5.1 - Change in Suppliers for Oxygen and Oxygen Equipment 40.6 - Payment for Capped Rental DME Items 40.6.1 - Change in Suppliers for Capped Rental DME Items 40.7 - Payment for Purchased Equipment 40.8 - Payment for Repair and Replacement of Beneficiary -Owned Equipment 40.9 - Payment for Enteral Nutrition Equipment 40.9.1 - Maintenance and Servicing of Enteral Nutrition Equipment 40.10 - Traveling Beneficiaries 40.10.1 - Traveling Beneficiaries and Transfer of Title of Oxygen Equipment or Capped Rental Items 40.11 - Billing Procedures Related to Advance Beneficiary Notice (ABN) Upgrades under the Competitive Bidding Program 40.12 - Billing Procedures Related to Downcoding under the Competitive Bidding Program 50 - Special Billing Instructions for the DMEPOS Competitive Bidding Program 50.1 - Electronic Submission of Claims and Mandatory Assignment 50.2 - New Modifiers for DMEPOS Competitive Bidding Billing 50.3 - Billing for Items in Multiple Product Categories 50.4 - Claims Jurisdiction and Billing Procedures for Traveling Beneficiaries 50.5 - Claims for DMEPOS Items Furnished to a Beneficiary by a Skilled Nursing Facility (SNF) or a Nursing Facility (NF) 50.6 - Billing for Mail Order Items 50.7 - Claims Submitted for Physicians/Practitioners Who Furnish Competitively Bid Items 50.8 - Billing for Oxygen and Oxygen Equipment 50.9 - Billing for Capped Rental DME Items 50.9.1 - Certificates of Medical Necessity (CMN) and Capped Rental DME Billing 50.10 - Claims Submitted for Hospitals Who Furnish Competitively Bid Items 50.11 - Claims Submitted for Medicare Beneficiaries Previously Enrolled in a Medicare Advantage Plan 50.12 - Claims for Repairs and Replacements 50.13 - Billing for Oxygen Contents to Suppliers After the 36th Month Rental Cap 50.14 - Purchased Accessories & Supplies for Use With Grandfathered Equipment 50.15 - Hospitals Providing Walkers and Related Accessories to Their Patients on the Date of Discharge 50.16 - Exception for Wheelchair Accessories Furnished with Non- Competitively Bid Wheelchair Base Equipment 01 - Foreword (Rev. 1502; Issued: 05- 09-08; Effective/Implementation Date: 06 -09-08) 42 CFR 411.15 and 414 This ch apter provides guidance on the Medicare DMEPOS Competitive Bidding Program and general instructions on billing and claims processing for DMEPOS items subject to this program. General instructions on billing and claims processing for DMEPOS items, except a s noted in this chapter, are in Chapter 20 of this manual. The payment rules for DMEPOS items specified in Chapter 20 of this manual generally apply to DMEPOS competitively bid items and services unless otherwise noted in this chapter. Coverage requireme nts in the Medicare Benefit Policy Manual and National Coverage Determinations manual will continue to apply to the Medicare DMEPOS Competitive Bidding Program unless noted otherwise in this chapter. The instructions in this chapter are applicable to items and services subject to the Medicare DMEPOS Competitive Bidding Program unless otherwise noted. They pertain to Medicare contractors, including, but not limited to: Medicare Administrative Contractors (MACs), Program Safeguard Contractors (PSCs), a nd the DMEPOS Competitive Bidding Implementation Contractor (CBIC). These instructions are also applicable to DMEPOS suppliers. 10 - Background (Rev. 1502; Issued: 05- 09-08; Effective/Implementation Date: 06 -09-08) Section 1834 of the Social Security Act (the Act), as added by section 4062 of the Omnibus Budget Reconciliation Act of 1987 (OBRA 87), Public Law 100 -203, provides for implementation of a fee schedule methodology for most durable medical equipment (DME), prosthetic devices, and orthotic de vices furnished after January 1, 1989. The Medicare DMEPOS Competitive Bidding Program is required by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (the MMA) (Pub. L. 108- 173), which amended section 1847 of the Act. Section 1847 of the Act, as amended, requires that competitive bidding programs be established and implemented in areas throughout the United States. In general, the statute requires that the Secretary implement a competitive bidding program that replaces the current DMEPOS fee schedule methodology for determining payment rates for certain DMEPOS items in competitive bidding areas. This fee schedule methodology will continue to be used for payment of Medicare covered DMEPOS non- competitively bid items or services. The payment rates for DMEPOS competitively bid items are determined by using bids submitted by DMEPOS suppliers. The intent is to improve the methodology for setting DMEPOS payment amounts. These payments will reduce beneficiary out -of-pocket expenses and save the Medicare program money while ensuring beneficiary access to quality DMEPOS items and services from qualified suppliers. The Medicare DMEPOS Competitive Bidding Program is being phased in, beginning in 2007 with 10 metropolitan statistical are as (MSAs) for certain DMEPOS items. The program will be expanded into 70 additional MSAs in 2009, and then into additional areas (MSAs or other defined areas) after calendar year 2009. 10.1 - Competitive Bidding Implementation Contractor (CBIC) (Rev. 1502; Issued: 05 -09-08; Effective/Implementation Date: 06 -09-08) Section 1847 of the Act authorizes CMS to contract with a Competitive Bidding Implementation Contractor (CBIC), to conduct certain functions relating to the administration of the Medicare DME POS Competitive Bidding Program. These functions include: preparing the request for bids (RFB); performing preliminary bid evaluations; and ensuring that suppliers meet all applicable financial and quality standards. In addition, the CBIC supports CMSs efforts to conduct an educational program for beneficiaries, suppliers and referral agents. The CBIC also assists CMS and its contractors in monitoring the program's effectiveness, access and quality. The CBICs Web site, at http://www.dmecompetitivebid.com, contains important and up- to-date information on the Medicare DMEPOS Competitive Bidding Program. 10.2 - Definitions (Rev. 1502; Issued: 05-09- 08; Effective/Implementation Date: 06 -09-08) Advance Beneficiary Notice (ABN) is a written form provided by the supplier and signed by the Medicare beneficiary in which the beneficiary agrees to pay out of pocket for charges not paid for by Medicare. Bid means an offer to furnish an item in a competitive bidding area (CBA) for a particular price and time period that includes, where appropriate, any services that are directly related to the furnishing of the item. Competitive Bidding Area (CBA) is the area determined by CMS, wherein suppliers are awarded contracts to furnish certain DMEPOS items to Medicare beneficiaries who obtain competitive bid items in the CBA. Competitive bidding program means a program under the Medicare DMEPOS Competitive Bidding Program established within a designated CBA for a specified product category and contract period. Composite bid means the sum of a suppliers weighted bids for all items within a product category within a CBA for purposes of allowing a comparison across bidding suppliers. Contract supplier means an entity that is awarded a contract by CMS to furnish items under a competitive bidding program. Grandfathered item means any one of the following categories of items for which payment is made on a rental basis prior to the implementation of a competitive bidding program and for which payment is made after implementation of a competitive bidding program to a grandfathered supplier that continues to furnish the items in accordance with 42 CFR 414.408(j): (1) Inexpensive or routinely purchased items furnished on a rental basis; (2) Items requiring frequent and substantial servicing; (3) Oxygen and oxygen equipment (not including oxygen contents, supplies or accessories furnished for use in conjunction with beneficiary -owned equipment); (4) Ca pped rental items furnished on a rental basis. Grandfathered supplier means a noncontract supplier that elects to continue to furnish grandfathered items to beneficiaries in a CBA to whom the supplier had furnished the items prior to implementation of the competitive bidding program. The beneficiary must elect to continue to receive the item from the grandfathered supplier. Item means a product included in a competitive bidding program that is identified by a HCPCS code, which may be specified for competitive bidding (for example, a product when it is furnished through mai l order), or a combination of codes and/or modifiers. An item also includes the services directly related to the furnishing of that product to the beneficiary, including caregiver training and follow -up, suppliers shipping charges, maintaining rented equipment in proper order, education, delivery, set -up and retrieval as appropriate. Item weight is a number assigned to an item based on national allowed services for that item when compared to other items in the same product category. Mail order refers to items ordered remotely (i.e., by phone, email, internet, or mail) and delivered to the beneficiarys residence by common carriers (e.g., U.S. Postal Service, Federal Express, United Parcel Service) and does not include items obtained by beneficiaries from local supplier storefronts.

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(4) Ca pped rental items furnished on a rental basis. Grandfathered supplier means a noncontract supplier that elects to continue to furnish grandfathered items to beneficiaries in a CBA to whom the supplier had furnished the items prior to implementation of the competitive bidding program. The beneficiary must elect to continue to receive the item from the grandfathered supplier. Item means a product included in a competitive bidding program that is identified by a HCPCS code, which may be specified for competitive bidding (for example, a product when it is furnished through mai l order), or a combination of codes and/or modifiers. An item also includes the services directly related to the furnishing of that product to the beneficiary, including caregiver training and follow -up, suppliers shipping charges, maintaining rented equipment in proper order, education, delivery, set -up and retrieval as appropriate. Item weight is a number assigned to an item based on national allowed services for that item when compared to other items in the same product category. Mail order refers to items ordered remotely (i.e., by phone, email, internet, or mail) and delivered to the beneficiarys residence by common carriers (e.g., U.S. Postal Service, Federal Express, United Parcel Service) and does not include items obtained by beneficiaries from local supplier storefronts. Mail order contract supplier is a contract supplier from which items are ordered remotely and that furnishes items through common carrier (e.g., U.S. Postal Service, Federal Express, and United Parcel Service) to beneficiaries who maintain a permanent residence in a CBA. Metropolitan Statistical Area (MSA) has the same meaning as that given by the Office of Management and Budget. Minimal self -adjustment means an adjustment that the beneficiary, caretaker for the beneficiary, or supplier of the device can perform and does not require the services of a certified orthotist (that is, an individual certified by either the American Board for Certification in Orthotics and Prosthetics, Inc., or the Board for Orthotist/Prosthetist Certification) or an individual who has specialized training. Physician has the same meaning as in section 1861(r) of the Act. Nationwide competitive bidding area means a CBA that includes the United States, its Territories, and the District of Columbia. Nationwide mail order contract supplier means a mail order contract supplier that furnishes items in a nationwide competitive bidding area. Network means a group of small suppliers t hat form a legal entity to provide competitively bid items throughout the entire geographic area of a CBA. Noncontract supplier means a supplier that is not awarded a contract by CMS to furnish items included in a competitive bidding program. Off-The-Shelf (OTS) orthotics are orthotics that require minimal self -adjustment for appropriate use and do not require expertise in trimming, bending, molding, assembling, or customizing to fit the individual. Pivotal bid means the lowest composite bid based on bids submitted by suppliers for a product category that includes a sufficient number of suppliers to meet beneficiary demand for the items in that product category. Product category means a grouping of related items that are used to treat a similar medical condition. Regional competitive bidding area means a CBA that consists of a region of the United States, its Territories, and the District of Columbia. Regional mail order contract supplier means a mail order contract supplier that furnishes items in a re gional competitive bidding area. Single payment amount means the allowed payment amount for an item furnished under a competitive bidding program. Small supplier means a supplier that generates gross revenue of $3.5 million or less in annual receipts, including Medicare and non -Medicare revenue. Specialty supplier means a skilled nursing facility (SNF) or nursing facility (NF) that, at the time of bidding, elects to furnish certain competitive bidding items only to its residents and that is awarded a contract. Supplier means an entity with a valid Medicare supplier number, including an entity that furnishes an item through the mail. Treating practitioner means a physician assistant, nurse practitioner, or clinical nurse specialist, as those terms are defined in section 1861(aa)(5) of the Act. Weighted bid means the item weight multiplied by the bid price submitted for that item. 20 - DMEPOS Competitive Bidding Process (Rev. 1502; Issued: 05- 09-08; Effective/Implementation Date: 06 -09-08) To be considered for participation in the Medicare DMEPOS Competitive Bidding Program, suppliers must submit a bid in each CBA for each product category that they want to furnish to Medicare beneficiaries. DMEPOS suppliers must submit a bid amount for ever y item within a product category. All DMEPOS suppliers that submit a bid must meet the eligibility requirements in 42 CFR 411.414(b)- (d) and the bidding requirements established in the RFB. The RFB may be found on the CBIC Web site at http://www.dmecompetitivebid.com . Bids are evaluated to determine whether the supplier will be able to participate in the program for the duration of the contract period. A composite bid (a suppliers weighted bids for all i tems within a product category within a CBA) is calculated for each supplier by product category and by CBA. These composite bids are then ranked in order from the highest to the lowest. The lowest ranked composite bid that includes a sufficient number of qualified suppliers to meet beneficiary demand for the items in a product category will become the pivotal bid. Qualified suppliers that meet all of our requirements and whose composite bids are less than or equal to the pivotal bid will be offered a contract to participate in the Medicare DMEPOS Competitive Bidding Program. Also, additional small suppliers may be added to meet our small supplier target (see section 20.5.1). During the contracting process, additional suppliers may be awarded a contract to meet beneficiary demand. 20.1 - Items Subject to Competitive Bidding (Rev. 1502; Issued: 05-09- 08; Effective/Implementation Date: 06 -09-08) The general categories of items that are subject to competitive bidding include: DME and medical supplies, including supplies necessary for the use of DME and items used in infusion and drugs (other than inhalation drugs), but excluding class III devices under the Federal Food, Drug, and Cosmetic Act. Enteral nutrients, equipment, and supplies; OTS orthotics DMEPOS items subject to competitive bidding are phased in under the programs, beginning with the highest cost and highest volume items and services or those items and services that the Secretary determines have the largest savings potential. Specific items are designated for inclusion in competitive bidding programs through program instructions or other means (e.g., Web site posting). A listing of the items per CBA for round 1 of the DMEPOS Competitive Bidding Program is available at the CBIC Web site, http://www.dmecompetitivebid.com. 20.2 - Competitive Bidding Areas (CBAs) (Rev. 1502; Issued: 05-09- 08; Effective/Implementation Date: 06 -09-08) A CBA is designated by specific ZIP Codes. A CBA that is i dentified with a specific MSA may be concurrent with, larger than or smaller than the related MSA depending on a variety of considerations. Areas that may be exempt from the Medicare DMEPOS Competitive Bidding Program include rural areas and areas with lo w population density within urban areas (i.e., MSAs) that are not competitive, unless there is a significant national market through mail order for a particular item or service. The CBA will be the area within which certain DMEPOS items must be furnished by contract suppliers unless an exception applies. CBAs are designated through program instructions or other means (e.g. Web site posting). A listing of the ZIP Codes per CBA for round 1 of the DMEPOS Competitive Bidding Program is available at CBIC Web site, http://www.dmecompetitivebid.com. ZIP Codes for future rounds will also be listed on this Web site. The DME MACs will be notified of any changes to ZIP Codes as often as weekly via systematic updates to VMS. 20.3 - No Administrative or Judicial Review (Rev. 1502; Issued: 05-09- 08; Effective/Implementation Date: 06 -09-08) There is no administrative or judicial review for: The awarding of contracts; The establishment of payment amounts; Designation of CBAs; The phase-in of competitive bidding programs; The selection of items for competitive bidding programs; or The bidding structure and number of contract suppliers selected. A denied claim is not appealable if the denial is based on a determination by CMS that a competitively bid item was furnished in a CBA in a manner not authorized by 42 CFR 414 Subpart F. 20.4 - Eligibility Requirements to Submit a Bid (Rev. 1502; Issued: 05-09- 08; Effective/Implementation Date: 06 -09-08) To be eligible to bid, all suppliers must meet the requirements in 42 CFR 414.414. For example, the suppliers must be in good standing and have an active National Supplier Clearinghouse number (NSC#), meet quality standards and be accredited by a CMS approved accreditation organization (unless CMS specifies that a pending accreditation application is acceptable) for the item being bid. Suppliers must be accredited by the deadline specified by CMS in order to be offered a contract. 20.5 - Becomin g a Contract Supplier (Rev. 1502; Issued: 05-09- 08; Effective/Implementation Date: 06 -09-08) Qualified suppliers that meet all competitive bidding requirements including, but not limited to, eligibility, financial and accreditation requirements and whos e composite bids are less than or equal to the pivotal bid, will be offered a contract to become a contract supplier. Contract suppliers will be held to all of the terms of their contracts for the duration of the contract period. See section 30 of this c hapter for more information about contract supplier responsibilities. For the first round of competitive bidding, the contract period is July 1, 2008 through June 30, 2011, with the exception of mail order diabetic supplies, whose contract period is July 1, 2008 through March 31, 2010. The length of a contract period may not exceed 3 years. 20.5.1 - Small Suppliers and Networks (Rev. 1502; Issued: 05- 09-08; Effective/Implementation Date: 06 -09-08) The Act mandates that appropriate steps be taken to en sure that small suppliers have an opportunity to be considered for participation in the Medicare DMEPOS Competitive Bidding Program. For competitive bidding purposes, the definition of a small supplier is a supplier that generates $3.5 million or less in annual receipts, including Medicare and non- Medicare revenue. Small suppliers have the option to form networks for bidding purposes. A network is a group of small suppliers that form a legal entity to provide competitively bid items throughout the entire geographical area of a CBA. The requirements for networks are as follows: A single legal entity must be formed for the purpose of submitting a bid as a network. One supplier must be designated as the primary supplier. The network must identify itself as a network and identify all members of the network in the bid application. Each member of the network must be independently eligible to bid. Each member of the network must satisfy all required eligibility, financial and accreditation requirements, and is responsible for the quality of the products, care and services provided to Medicare beneficiaries. If any member of the network is not compliant with these requirements, the network contract may be terminated. All contracts or other legal documents necessary to create the network entity must be in place and signed before the network entity may submit a bid. The network must include at least two but not more than 20 members. Each member of a network must furnish all the items in the product category for which the network is awarded a contract. Network members can only join one network per product category per CBA. Only small suppliers that are unable independently to serve the entire geographic area of a CBA may join the network. Each member of the network must sign a certification statement that must be included as part of the networks bid application. The certification statement must specify that the supplier joined the network because it is unable independently to furnish all of the items in the product category for which the network is submitting a bid to beneficiaries throughout the entire geographic area of the CBA. The network cannot be anticompetitive. Any suspected cases of Federal antitrust violations are referred to the Department of J ustice for review. For bid evaluation purposes, a networks combined total market share for each product category cannot exceed 20 percent of the Medicare demand for that product category in the CBA at the time of bidding. However, once a network receive s a contract, the network may expand and exceed the 20 percent limit on market share. Network members may not bid independently or as a member of another network for the same product category for which the network submits a bid in the same CBA. A supplie r can join different networks for different product categories or in different CBAs.

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Network members can only join one network per product category per CBA. Only small suppliers that are unable independently to serve the entire geographic area of a CBA may join the network. Each member of the network must sign a certification statement that must be included as part of the networks bid application. The certification statement must specify that the supplier joined the network because it is unable independently to furnish all of the items in the product category for which the network is submitting a bid to beneficiaries throughout the entire geographic area of the CBA. The network cannot be anticompetitive. Any suspected cases of Federal antitrust violations are referred to the Department of J ustice for review. For bid evaluation purposes, a networks combined total market share for each product category cannot exceed 20 percent of the Medicare demand for that product category in the CBA at the time of bidding. However, once a network receive s a contract, the network may expand and exceed the 20 percent limit on market share. Network members may not bid independently or as a member of another network for the same product category for which the network submits a bid in the same CBA. A supplie r can join different networks for different product categories or in different CBAs. If a network is awarded a contract, each member of the contracted network will submit its own Medicare claims and will be paid directly by Medicare for products and servi ces it furnishes under the Medicare DMEPOS Competitive Bidding Program. 20.5.2 - Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs) (Rev. 1502; Issued: 05- 09-08; Effective/Implementation Date: 06 -09-08) The Medicare DMEPOS Competitive Bidding Program applies to SNFs and NFs located in a CBA to the extent their residents receive competitively bid items under Medicare Part B. Unlike most suppliers, SNFs and NFs have the option to bid for, and be awarded, contracts to be specialty suppli ers that only furnish competitively bid items to their own residents. SNFs and NFs may elect to submit a bid as a specialty supplier by indicating on the RFB that they will only furnish competitive bid items to their own residents. Any SNF or NF awarded a contract would be paid the single payment amount for those items. SNFs and NFs that elect to be specialty suppliers may not furnish competitively bid items and services to Medicare beneficiaries outside their facilities for purposes of Medicare payment . If a SNF or NF is not awarded a contract, it must use a contract supplier for the CBA to furnish competitively bid items to its residents. SNFs and NFs can also become regular contract suppliers that furnish competitively bid items to beneficiaries thr oughout a CBA. If a SNF or NF is not a contract supplier (either a specialty contract supplier or a regular contract supplier), it must use a contract supplier for its CBA to furnish competitively bid items to its residents. 20.5.3 - Home Health Agencies (Rev. 1532, Issued: 06- 11-08, Effective: 07- 01-08, Implementation: 07- 07-08) Home health agencies must submit a bid and be awarded a contract for the DMEPOS Competitive Bidding Program in order to furnish competitively bid items directly to Medicare beneficiaries who maintain a permanent residence in a CBA. If a home health agency is not awarded a contract to furnish competitively bid items, then they must use a contract supplier for these items. 20.5.3.1 - Mail -Order Suppliers for Diabetic Supplie s (Rev. 1502; Issued: 05- 09-08; Effective/Implementation Date: 06 -09-08) Medicare beneficiaries who maintain a permanent residence in a CBA in which CMS has implemented a competitive bidding program for mail order diabetic supplies may purchase their diabetic testing supplies from: A mail order contract supplier for the CBA in which the beneficiary resides; or Any enrolled Medicare supplier if the diabetic testing supplies are furnished at a storefront and are not subject to a competitive bidding prog ram established for non- mail order diabetic supplies. Mail order contract suppliers will be reimbursed at the single payment amount for mail order diabetic supplies for the CBA in which the beneficiary maintains a permanent residence. In situations where a competitive bidding program has not been established for non- mail order diabetic supplies, noncontract suppliers that do not furnish items through mail order will be reimbursed at the fee schedule amount for the state in which the beneficiary maintains a permanent residence. Medicare payment will not be made to noncontract suppliers that furnish mail order diabetic testing supplies to Medicare beneficiaries residing in a CBA. Mail order diabetic suppliers must use the HCPCS modifier KL on each claim to indicate that the item was furnished on a mail order basis. The modifier must be used for both competitive bidding and non- competitive bidding mail order diabetic supplies. Suppliers that furnish mail order diabetic items that fail to use the HCPCS modifier KL on the claim may be subject to penalties under of the False Claims Act. 20.5.4 - Items Furnished on a Mail Order Basis (Rev. 1532, Issued: 06- 11-08, Effective: 07- 01-08, Implementation: 07- 07-08) A Medicare beneficiary who maintains a permanent r esidence in a CBA for which we have done competitive bidding for mail order items may purchase their mail order items from: (1) a mail order contract supplier for that CBA; or (2) a noncontract supplier, if the item is purchased at a storefront. In situat ions where the beneficiary elects to obtain the item from a local storefront or from a local supplier via a mode of delivery other than mail order and the item is not subject to a competitive bidding program established for non -mail order items, the beneficiary may obtain the item from any Medicare enrolled supplier. 20.5.4.1 - Mail -Order Suppliers for Diabetic Supplies (Rev. 1532, Issued: 06- 11-08, Effective: 07- 01-08, Implementation: 07- 07-08) Medicare beneficiaries who maintain a permanent residence in a CBA in which CMS has implemented a competitive bidding program for mail order diabetic supplies may purchase their diabetic testing supplies from: A mail order contract supplier for the CBA in which the beneficiary resides; or Any enrolled Medicare s upplier if the diabetic testing supplies are furnished at a storefront and are not subject to a competitive bidding program established for non- mail order diabetic supplies. Mail order contract suppliers will be reimbursed at the single payment amount for mail order diabetic supplies for the CBA in which the beneficiary maintains a permanent residence. In situations where a competitive bidding program has not been established for non- mail order diabetic supplies, noncontract suppliers that do not furnish items through mail order will be reimbursed at the fee schedule amount for the state in which the beneficiary maintains a permanent residence. Medicare payment will not be made to noncontract suppliers that furnish mail order diabetic testing supplies to Medicare beneficiaries residing in a CBA. Mail order diabetic suppliers must use the HCPCS modifier KL on each claim to indicate that the item was furnished on a mail order basis. The modifier must be used for both competitive bidding and non- competitive bidding mail order diabetic supplies. Suppliers that furnish mail order diabetic items that fail to use the HCPCS modifier KL on the claim may be subject to penalties under of the False Claims Act. 20.6 - Noncontract Suppliers (Rev. 1502; Issued: 05- 09-08; Effective/Implementation Date: 06 -09-08) Noncontract suppliers that furnish competitively bid items in a CBA are not eligible for Medicare payment for the competitively bid items for that CBA unless one or more of the following exceptions appli es: Suppliers of Grandfathered DME - Beneficiaries who are receiving oxygen and oxygen equipment or rented DME at the time the competitive bidding program becomes effective may elect to continue to receive these items from a noncontract supplier if the supplier is willing to continue furnishing these items. See section 20.6.1 of this chapter for more information on grandfathering. Repairs/Replacement - Beneficiaries who maintain a permanent residence in a CBA may go to any Medicare- enrolled supplier (cont ract or noncontract supplier) for repairs or replacement parts for beneficiary owned items. Labor to repair equipment is not subject to competitive bidding and, therefore, will be paid in accordance with Medicares general payment rules. Payment for part s that are not competitively bid items and that are needed to repair a beneficiary -owned item will also be paid in accordance with these rules. Payment for replacement parts that are part of the competitive bidding program for the areas in which the benef iciary resides would be paid at the single payment amount. Unlike repairs, beneficiaries must obtain replacements of certain base equipment they own (e.g., wheelchairs or hospital beds) from a contract supplier, when the base equipment must be replaced in its entirety, rather than replacement parts for the repair of the base equipment. A contract supplier is required to service all rented items included in its contract. Physicians and Other Practitioners Who are Enrolled Medicare DMEPOS Suppliers - Physi cians and treating practitioners have the option to furnish certain types of competitively bid items in a CBA to their own patients without submitting a bid and being a selected as a contract supplier, provided the following requirements are met: o The item s are limited to crutches, canes, walkers, folding manual wheelchairs, blood glucose monitors, and infusion pumps that are DME. o The items must be billed using a billing number assigned to the physician, the treating practitioner or a group practice to which the physician or treating practitioner has reassigned the right to receive Medicare payment for competitive bid items. Physicians and treating practitioners who do not to become contract suppliers may only provide the bid items identified above to thei r own patients and will not be allowed to act as contract suppliers to provide bid items to beneficiaries for purposes of Medicare payment. The physician or treating practitioner will be paid the single payment amount when the furnished item is a competitive bid item and the beneficiary maintains a permanent residence in a CBA. Physical Therapists and Occupational Therapists in Private Practice Who are Enrolled Medicare DMEPOS Suppliers -- Physical therapists and occupational therapists in private practice have the option to furnish certain types of competitively bid items to their own patients without submitting a bid and being a selected as a contract supplier, provided the following requirements are met: o The only competitive bid items they may f urnish without becoming a contract supplier are OTS orthotics. o The items must be furnished only to their own patients as part of the physical or occupational therapy service. Physical and occupational therapists in private practice who do not to become contract suppliers may only provide competitive bid OTS orthotics to their own patients and will not be allowed to act as contract suppliers for purposes of Medicare payment. The physical or occupational therapist will be paid at the single payment amount when the furnished item is a competitive bid item and the beneficiary maintains a permanent residence in a CBA. Medicare Secondary Payer - If a Medicare beneficiary is required under his or her primary insurance policy to use a supplier that is a noncontr act supplier, Medicare may make a secondary payment to a noncontract Medicare -enrolled supplier for competitive bid items. The supplier must have a valid NSC# and be eligible to receive secondary payments. The amount paid to the supplier will be calculated in accordance with established Medicare secondary payment rules. If none of the exceptions above apply, then the noncontract supplier is responsible for notifying the beneficiary that it is not a contract supplier for the competitive bidding item in the CBA, and the beneficiary must go to a contract supplier for that item in order for Medicare to make payment for the item. CMS has a supplier locator tool in order to assist beneficiaries and suppliers in finding contract suppliers. The supplier locator tool can be found at www.medicare.gov. Beneficiaries may also call 1 -800-Medicare to obtain information about contract suppliers. 20.6.1 - Special Rules for Certain Rented Durable Medical Equipment (DME), Oxygen and Oxygen Equipment (Grandfathered Suppliers and Items) (Rev. 1502; Issued: 05-09- 08; Effective/Implementation Date: 06 -09-08) Suppliers that were furnishing certain rented DME, or oxygen and oxygen equipment at the time a competitive bidding program begins in a CBA, may become grandfathered suppliers by continuing to furnish these items to the Medicare beneficiaries who have been receiving these items, even if the suppliers do not become contract suppliers for these items in the CBA. Grandfathered items must be any of the following: (1) Inexpensive or routinely purchased items furnished on a rental basis; (2) Items requiring frequent and substantial servicing; (3) Oxygen and oxygen equipment (not including oxygen contents, supplies or accessories furnished for use in conjunction with beneficiary-owned equipment); (4) Capped rental items furnished on a rental basis. 20.6.1.1 - Requirements for Grandfathered Suppliers (Rev. 1502; Issued: 05-09- 08; Effective/Implementation Date: 06 -09-08)

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20.6.1 - Special Rules for Certain Rented Durable Medical Equipment (DME), Oxygen and Oxygen Equipment (Grandfathered Suppliers and Items) (Rev. 1502; Issued: 05-09- 08; Effective/Implementation Date: 06 -09-08) Suppliers that were furnishing certain rented DME, or oxygen and oxygen equipment at the time a competitive bidding program begins in a CBA, may become grandfathered suppliers by continuing to furnish these items to the Medicare beneficiaries who have been receiving these items, even if the suppliers do not become contract suppliers for these items in the CBA. Grandfathered items must be any of the following: (1) Inexpensive or routinely purchased items furnished on a rental basis; (2) Items requiring frequent and substantial servicing; (3) Oxygen and oxygen equipment (not including oxygen contents, supplies or accessories furnished for use in conjunction with beneficiary-owned equipment); (4) Capped rental items furnished on a rental basis. 20.6.1.1 - Requirements for Grandfathered Suppliers (Rev. 1502; Issued: 05-09- 08; Effective/Implementation Date: 06 -09-08) 20.6.1.1.1 - Eligibility (Rev. 1502; Issued: 05-09- 08; Effective/Implementation Date: 06 -09-08) All suppliers must be in good standing and have an active NSC number which requires that the supplier meet any local and State licensure requirements, if any, for provision of the grandfathered item. 20.6.1.1.2 - Servicing Current Beneficiaries (Rev. 1502; Issued: 05-09- 08; Effective/Implementation Date: 06 -09-08) A supplier that chooses to continue to furnish a grandfathered item(s) to any beneficiary in a CBA must continue to furnish that grandfathered item(s) to all beneficiaries who elect to continue receiving that item(s) from that supplier for the remainder of the payment period for the item(s), unless the item is no longer medically necessary. In order to participate as a grandfathered supplier, the supplier must update its billing systems to incorporate any new billing codes, modifiers or other billing instr uctions for grandfathered suppliers in the Medicare DMEPOS Competitive Bidding Program. 20.6.1.1.3 - Notification to Beneficiaries by Suppliers that Choose to Become Grandfathered Suppliers (Rev. 1532, Issued: 06- 11-08, Effective: 07-01-08, Implementation : 07-07-08) A noncontract supplier that elects to become a grandfathered supplier is responsible for providing notification to its Medicare customers residing in CBAs who are furnished items identified in section 20.6.1. This notification should meet the following guidelines: NOTE: This notification should only be sent to beneficiaries who the supplier is currently serving and who maintain a permanent residence in a CBA. The list of ZIP Codes for each CBA, the list of the HCPCS for competitively bid items, and the single payment amounts for these items are located in public use files on the CBIC Web site at: http://www.dmecompetitivebid.com/palmetto/cbic.nsf/DocsCat/Home. It should state that the supplier is offering to continue to furnish rental DME, oxygen and oxygen equipment and/or related accessories and supplies that it is currently furnishing to the beneficiary (i.e., before the start of the competitive bidding program) and to provide these items to the beneficiary for the remainder of the rental period. It should state that the beneficiary has the choice to continue to receive a grandfathered item(s) from the grandfathered supplier or to elect to begin receiving the i tem(s) from a contract supplier after the competitive bidding program begins. It should provide the suppliers telephone number so the beneficiary or caregiver may call and notify the supplier of his/her election. The supplier should provide notification to the beneficiary at least 30 days before the start date of the implementation of the Medicare DMEPOS Competitive Bidding Program. The supplier should receive an election from a beneficiary and maintain a record as to whether the beneficiary chose to continue to receive the item from a grandfathered supplier, chose to go to a contract supplier to receive the item or did not respond. The record should indicate, at a minimum, the date that the beneficiary is notified that the supplier elected to become a grandfathered supplier for the item(s), the date the beneficiary made an election (if applicable), and the methods of communication used in the case of each election activity (e.g. letter to the beneficiary). The supplier should inform the beneficiary of the end date of service and that arrangements will be made to pick -up the item within 10 days of picking up the item. The supplier should remind the beneficiary of the date and time the equipment will be picked up within 2 business days of picking up the equipment. Recommended Schedule for Suppliers to Notify Beneficiaries of the Necessity to Decide on Arrangements for Choosing to Use a Grandfathered Supplier or Contract Supplier Notification - Supplier Number of Days Before the Start Date of the Competitive Bidding Program Initial Notification in writing 30 days Notification before picking up equipment Within 10 days before picking up the equipment. Final Notification before picking up equipment Within 2 business days of picking up the equipmen t ** A sample notification letter will be posted on the CBIC Web site at www.dmecompetitivebid.com. 20.6.1.1.4 - Notification to Beneficiaries for Suppliers that Choose Not to Become Grandfathered Supplie rs (Rev. 1532, Issued: 06- 11-08, Effective: 07-01-08, Implementation: 07-07-08) A noncontract supplier that elects not to become a grandfathered supplier should provide notification to the beneficiary stating the supplier will not continue to furnish, after the start of the Medicare DMEPOS Competitive Bidding Program, the competitively bid item(s) that the beneficiary has been receiving from the supplier. This notification should meet the following guidelines: NOTE: This notification should only be sent to beneficiaries who the supplier is currently serving and who maintain a permanent residence in a CBA. The list of ZIP Codes for each CBA, the list of the HCPCS for competitively bid items, and the single payment amounts for these items are located in public use files on the CBIC Web site at: http://www.dmecompetitivebid.com/palmetto/cbic.nsf/DocsCat/Home. It should state that the supplier will not continue to furnish rental DME and/or oxygen and oxygen equipment that it is currently furnishing to the beneficiary after the start of the competitive bidding program and that the beneficiary may need to select a contract supplier to continue to receive these items. It should inform the beneficiary of the start of the competitive bidding program and the date the supplier plans to pick up the item. It should inform the beneficiary that he/she may obtain information about the competitive bidding program by calling 1-800- MEDICAR E or accessing www.medicare.gov on the Internet. It should also refer him/her to the supplier locator tool on www.medicare.gov . The supplier should provide this written notification to the beneficiary 30 days before the start date from the implementation of the Medicare DMEPOS Competitive Bidding Program. The supplier should inform the beneficiary of the end date of service and that arrangements will be made to pick -up the item within 10 days of picking up the item. The supplier should remind the beneficiary of the date and time the equipment will be picked up within 2 business days of picking up the equipment. Recommended Schedule for Suppliers to Notify Beneficiaries to Lo cate a Contract Supplier Notification - Supplier Number of Days Before the Start Date of the Competitive Bidding Program Initial Notification in writing 30 days Notification before picking up equipment Within 10 days before picking up the equipment. Final Notification before picking up equipment Within 2 business days of picking up the equipment ** A sample notification letter will be posted on the CBIC Web site at www.dmecompetitivebid.com. 20.6.2 - New Period of Continuous Use (Rev. 1502; Issued: 05-09- 08; Effective/Implementation Date: 06 -09-08) In the case of grandfathered items that are oxygen and oxygen equipment or capped rental DME, whenever a new period of continuous use begins following a break in use of greater than 60 days plus the days remaining in the last rental month, after the start of the competitive bidding program, the new or additional equipment covered under the new period of continuous use must be obtained from a competitive bidding contract supplier. See 42 CFR 414.230 for determining a period of continuous use. 20.6.3 - Picking Up Equipment (Rev. 1502; Issued: 05-09- 08; Effective/Implementation Date: 06 -09-08) Under no circumstances may the supplier discontinue services by picking up a medically necessary item(s) prior to the end of a month for which the supplier is eligible to receive a rental payment, even if the last day ends after the start date of the Medicare DMEPOS Competitive Bidding Program. A noncontract supplier may only pick up medically necessary oxygen equipment or capped rental DME prior to the start of the competitive bidding program or prior to the end of the month for which the supplier is eligible to receive payment if the beneficiary relocates his/her permanent residence outside the CBA and outside the normal service area of the supplier. The pick up by the noncontract supplier and the delivery by the contract supplier of the equipment should occur on the same day and month as the item rental anniversa ry date. The anniversary date is the day of the month on which the item was first delivered to the beneficiary. For capped rental DME or oxygen and oxygen equipment, the noncontract supplier is responsible for submitting a claim for any rental period tha t begins prior to the start of the competitive bidding program. In all cases, we expect the contract supplier to consult with the noncontract supplier to obtain the anniversary date. The noncontract supplier should work with the contract supplier so that there is no break in service or furnishing of medically necessary items. We expect the contract supplier and the current supplier will work together to make arrangements suitable to the beneficiarys needs. Examples: Using July 1st as the beginning dat e of the Medicare DMEPOS Competitive Bidding Program A. If a beneficiarys last anniversary date before the beginning of the competitive bidding program is June 29, the noncontract supplier must submit a claim for the rental month beginning June 29 and e nding July 28th. The noncontract supplier must not pick up the equipment prior to July 29th. In this case, the current supplier would pick up its equipment, on July 29th, and the contract supplier would deliver its equipment on July 29th. B. If a bene ficiarys anniversary date is July 1st, the beginning date for the competitive bidding program, the noncontract supplier must not pick up the equipment before July 1st and must not submit a claim for the July rental period. The contract supplier should de liver the equipment to the beneficiary on July 1st and must submit a claim for this month. 20.6.4 - Transfer of Title for Oxygen Equipment and Capped Rental DME (Rev. 1502; Issued: 05- 09-08; Effective/Implementation Date: 06 -09-08) Title to oxygen equipment transfers to the beneficiary on the first day that begins after the 36th continuous month during which Medicare payment is made for rental of the equipment. Title for capped rental equipment transfers to the beneficiary on the first day that begins after the 13th continuous month during which Medicare payment is made for the capped rental DME equipment. These requirements apply to all suppliers without regard to their grandfathered status. Suppliers that do not become contract suppliers or grandfathered suppliers must transfer title for the equipment to the beneficiary in accordance with these requirements even in situations where the 36th continuous month for oxygen equipment or the 13th continuous month for capped rental DME ends after the start date of the competitive bidding program. 20.6.5 - Capped Rental DME Furnished Prior to January 1, 2006 (Rev. 1502; Issued: 05- 09-08; Effective/Implementation Date: 06 -09-08) This section addresses situations where the beneficiary did not elect the purchase option described in section 30.5.2 of Chapter 20 for capped rental DME for which the first rental month occurred prior to January 1, 2006. In accordance with section 30.5.4 of Chapter 20, the supplier that provides the item in the 15th month of the rental period is responsible for supplying the equipment and for maintenance and servicing after the 15- month period. This requirement is not eliminated by any requirement under the competitive bidding program and applies to both contract and noncontract suppliers without regard to their grandfathered status. (See section 50.1 of Chapter 20).

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20.6.5 - Capped Rental DME Furnished Prior to January 1, 2006 (Rev. 1502; Issued: 05- 09-08; Effective/Implementation Date: 06 -09-08) This section addresses situations where the beneficiary did not elect the purchase option described in section 30.5.2 of Chapter 20 for capped rental DME for which the first rental month occurred prior to January 1, 2006. In accordance with section 30.5.4 of Chapter 20, the supplier that provides the item in the 15th month of the rental period is responsible for supplying the equipment and for maintenance and servicing after the 15- month period. This requirement is not eliminated by any requirement under the competitive bidding program and applies to both contract and noncontract suppliers without regard to their grandfathered status. (See section 50.1 of Chapter 20). 20.7 - Use of Advanced Beneficiary Notice (ABNs) (Rev. 1502; Issued: 05- 09-08; Effecti ve/Implementation Date: 06 -09-08) Except where an exception applies, a beneficiary has no financial liability to a noncontract supplier that furnishes an item included in the competitive bidding program for a CBA, unless the beneficiary has signed an Advance Beneficiary Notice (ABN). However, if a noncontract supplier in a CBA obtains a signed ABN indicating that the beneficiary was informed in writing prior to receiving the competitively bid item or service that there would be no payment by Medicare due to the supplier's non- contract status, the noncontract supplier may charge the beneficiary for the item or service. In this circumstance, non- contract suppliers cannot bill Medicare and receive payment for the competitively bid item or service. An ABN i s a written form provided by the supplier and signed by the Medicare beneficiary in which the beneficiary agrees to pay out of pocket for charges not paid for by Medicare. See Chapter 30 - Financial Liability Protections of this manual for general instruc tions relating to ABN requirements. In addition to the other uses of an ABN as defined in Chapter 30, an ABN informs a beneficiary before he or she receives specified items or services from a noncontract supplier that Medicare will probably not pay for the specified items or services for that particular beneficiary on that particular occasion if furnished by a noncontract supplier. 30 - Contract Supplier Responsibilities (Rev. 1502; Issued: 05- 09-08; Effective/Implementation Date: 06 -09-08) 30.1 - Comp liance with Laws and Regulations (Rev. 1502; Issued: 05- 09-08; Effective/Implementation Date: 06 -09-08) A contract supplier, and its affiliated companies and subcontractors, must comply with all applicable Federal and State laws and regulations including, without limitation, the final rule on Competitive Acquisition for Certain DMEPOS and Other Issues that appeared in the Federal Register on April 10, 2007 (72 Fed. Reg. 17992) and 42 CFR, Part 414, Subpart F. A contract supplier must also comply with any applicable State licensing requirements pertaining to its functions as a contract supplier. 30.2 - Requirement to Maintain Medicare Billing Privileges and Accreditation (Rev. 1502; Issued: 05- 09-08; Effective/Implementation Date: 06 -09-08) A contract supplier must satisfy the enrollment standards specified in 42 CFR 424.57(c), meet applicable quality standards (both general quality standards and product specific quality standards) developed by CMS in accordance with section 1834(a)(20) of the Act, and be accredited by a CMS -approved accreditation organization for the duration of the contract period. Contract suppliers must maintain appropriate enrollment and accreditation throughout the term of their contracts. The contract supplier must not ify the CBIC in writing at the US postal or certified (physical) mailing address identified in the suppliers contract within five (5) business days of any changes to its Medicare billing privileges or accreditation status. 30.3 - Servicing the Entire Geo graphic Area of a CBA (Rev. 1502; Issued: 05- 09-08; Effective/Implementation Date: 06 -09-08) A contract supplier must agree to furnish all items under its contract to any beneficiary who maintains a permanent residence in or visits a CBA and requests th ose items from the contract supplier unless an exception applies. There are two exceptions. First, SNFs or NFS that become specialty suppliers only furnish competitive bidding items to their residents. Second, individual network members are not required to provide services through the entire geographic of a CBA. However, the network as a whole must provide services throughout the entire geographic area of a CBA. 30.4 - Prescription for Particular Brand, Item, or Mode of Delivery (Rev. 1532, Issued: 06- 11-08, Effective: 07- 01-08, Implementation: 07- 07-08) Contract suppliers are not required to furnish a specific brand name item or mode of delivery to a beneficiary unless prescribed by a physician or treating practitioner to avoid an adverse medical outcome. A physician or treating practitioner (that is a physician assistant, clinical nurse specialist, or nurse practitioner) may prescribe, in writing, a particular brand of a competitively bid item or mode of delivery for an item if he or she determines that the particular brand or mode of delivery is necessary to avoid an adverse medical outcome for the beneficiary. The physician or treating practitioner must document in the beneficiarys medical record the reason why the specific brand or mode of delivery is necessary to avoid an adverse medical outcome. This documentation should include the following: The products brand name or mode of delivery; The features that this product or mode of delivery has versus other brand name products or modes of delivery; and An explanation of how these features are necessary to avoid an adverse medical outcome. If a physician or treating practitioner prescribes a particular brand or mode of delivery t o avoid an adverse medical outcome, the contract supplier must either: (1) Furnish the particular brand or mode of delivery as prescribed by the physician or treating practitioner; (2) Consult with the physician or treating practitioner to find another appropriate brand of item or mode of delivery for the beneficiary and obtain a revised written prescription from the physician or treating practitioner; or (3) Assist the beneficiary in locating a contract supplier that can furnish the particular brand of item or mode of delivery prescribed by the physician or treating practitioner. Any change in the prescription requires a revised written prescription for Medicare payment. A contract supplier is prohibited from submitting a claim to Medicare if it furnishes an item different from that specified in the written prescription received from the beneficiarys physician or treating practitioner. 30.5 - No Discrimination Against Beneficiaries (Rev. 1502; Issued: 05-09- 08; Effective/Implementation Date: 06 -09-08) 42 CFR 414.422(c) specifies that contract suppliers may not discriminate against beneficiaries under the Medicare DMEPOS Competitive Bidding Program. The items furnished by a contract supplier must be the same items that the contract supplier makes available to other customers. All products provided must meet product specifications identified by the HCPCS coding system. 30.6 - Quarterly Reports (Rev. 1502; Issued: 05-09- 08; Effective/Implementation Date: 06 -09-08) The contract supplier must submit quarterly reports to the CBIC using Form CMS-10169C, The Medicare DMEPOS Competitive Bidding Program Contract Supplier Quarterly Report (OMB No. 0938- 1016), which can be accessed at the CBIC Web site at: http://www.dmecompetitivebid.com. The contract supplier must submit to the CBIC a quarterly report no later than ten (10) calendar days after each of the following dates: March 31, June 30, September 30, and December 31. If the due date for a particular quarterly report falls on a Saturday, Sunday, or Federal holiday, the report is due on the next business day. As provided in Form CMS-10169C, each quarterly report must disclose the following regarding each item specified by CMS that was furnished under its contract during the calendar quarter immediately preceding the reports due date: the items HCPCS code; the approximate number of items furnished; the manufacturer of the item; the items model name; and the items model number. The contract supplier must submit each quarterly report to the CBICs regular or certified mailing address identified in its contract. When the contract supplier submits the required quarterly reports, it should also review the Medicare Sup plier Directory, found at http://www.medicare.gov (in the section entitled Find Suppliers of Medical Equipment in Your Area) to determine whether the suppliers information is current, including the lists that indicate which manufacturers products that the contract supplier makes available to beneficiaries. If the information is not current, the contract supplier should submit current information to the CBICs regular or certified mailing address identified in its contract within ten (10) business days of the close of each quarter. 30.7 - Reporting Change of Ownership (CHOW) (Rev. 1502; Issued: 05-09- 08; Effective/Implementation Date: 06 -09-08) Pursuant to 42 CFR 414.422(d)(2), CMS may award a contract to an entity that merges with, or acquires, the contract supplier if (1) the successor entity meets all requirements applicable to contract suppliers for the competitive bidding program(s) to which the contract suppliers contract applies; and (2) the successor entity submits to CMS the documentation described in 42 CFR 414.414(b)-(d) if that documentation has not previously been submitted by the successor entity or the contract supplier that is being acquired, or is no longer current. The documentation required by 42 CFR 414.414(b)- (d) is necessary to substantiate compliance with basic eligibility requirements, quality standards, accreditation requirements and financial standards. The successor entity that is acquiring the assets of the contract supplier mu st also submit to CMS, at least 30 calendar days before the anticipated effective date of the change of ownership, an executed novation agreement acceptable to CMS. The novation agreement must state that the successor entity will assume all obligations un der the contract. If a new entity will be formed as a result of the merger or acquisition, the existing contract supplier must submit to CMS for review, at least 30 calendar days before the anticipated effective date of the change of ownership, its final draft of a novation agreement stating that the new entity will assume all obligations under the contract. With the final draft novation agreement, the existing contract supplier must submit the documentation described in 42 CFR 414.414(b)- (d) if the information previously submitted by the contract supplier is no longer current. The new entity must also submit to CMS, within 30 calendar days after the effective date of the change of ownership, an executed novation agreement acceptable to CMS stating that it will assume all obligations under the contract. The new entity must meet all requirements applicable to contract suppliers for the applicable competitive bidding program. The following chart illustrates the CHOW requirements needed to remain a contract supplier described above. Entity Requirement Number of Days to Meet Requirement Contract Supplier Only The existing contract supplier must notify CMS if it is negotiating a CHOW. 60 calendar days before the anticipated date of the change. If a new entity will be formed as a result of the merger or acquisition, the existing contract supplier must submit to CMS, its final draft of a novation agreement as described in 414.422(d)(2)(iii). At least 30 calendar days before the anticipated date of the CHOW . Successor Entity or New Entity The successor entity or new entity must submit to CMS the documentation in 414.414(b)-(d), if not submitted previously by the successor or the contract supplier or if no longer current. Duplicates of previously submitted information need not be submitted if that information is still current. Within 30 calendar days prior to the anticipated effective date of the CHOW. Entity Requirement Number of Days to Meet Requirement Successor Entity Only The successor entity that is acquiring the assets of the existing contract supplier must submit to CMS, a signed novation agreement acceptable to CMS, stating that it will assume all obligations under the contract. At least 30 calendar days before the anticipated effective date of the change of ownership. New Entity Only The new entity must submit to CMS an executed novation agreement acceptable to CMS. Within 30 calendar days after the effective date of the CHOW. NOTE: Successor and new entities must meet all requirements applicable to contract suppliers for the applicable competitive bidding program. Any communication with CMS regarding the change of ownership must be in writing and mailed to the appropriate address designated in the contract. 30.8 - Submission of Claims (Rev. 1502; Issued: 05-09- 08; Effectiv e/Implementation Date: 06 -09-08) A contract supplier must submit Medicare claims for payment in accordance with rules in this chapter.

(Medicare Claims Processing Manual)

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Any communication with CMS regarding the change of ownership must be in writing and mailed to the appropriate address designated in the contract. 30.8 - Submission of Claims (Rev. 1502; Issued: 05-09- 08; Effectiv e/Implementation Date: 06 -09-08) A contract supplier must submit Medicare claims for payment in accordance with rules in this chapter. 30.9 - Breach of Contract (Rev. 1502; Issued: 05-09- 08; Effective/Implementation Date: 06 -09-08) Pursuant to 42 CFR 414.422(f)(1), any violation of the terms of the contract by the contract supplier, including a failure to comply with licensing and accreditation requirements, constitutes a breach of contract. If a supplier breaches its contract, CMS may take one or mo re of the following actions: (i) Require the contract supplier to submit a corrective action plan (CAP); (ii) Suspend the contract suppliers contract; (iii) Terminate the contract; (iv) Preclude the contract supplier from future participation in the competitive bidding program; (v) Revoke the supplier number of the contract supplier; or (vi) Avail itself of other remedies allowed by law. CMS will notify the DME MACs in the event that a CMS action results in a termination or suspension of the contract. 30.10 - Request for Reconsideration (Rev. 1502; Issued: 05-09- 08; Effective/Implementation Date: 06 -09-08) CMS will notify the contract supplier before it takes a breach of contract action and will notify the supplier at that time of how it can ask for reconsideration of any breach of contract determination. 40 - Payment Rules (Rev. 1502; Issued: 05-09- 08; Effective/Implementation Date: 06 -09-08) A single payment amount is established for each competitive bid item for each CBA based on the bids submitted and accepted for that item. All payment for competitive bidding items is made on an assignment related basis. The payment basis for an item is 80 percent of the applicable single payment amount for the CBA in which the beneficiary maintains a permanent residence, less any unmet Part B deductible described in 1833(b) of the Act. If an item that is included in a competitive bidding program is furnished to a beneficiary who does not maintain a permanent residence in a CBA, the payment basis for the item is 80 percent of the lesser of the actual charge of the item, or the applicable fee schedule amount for the item. The single payment amount calculated for each item under each competitive bidding program is paid for the duration of the competitive bidding program and will not be adjusted by any update factor. Payment for items or services furnished by a supplier under the Medicare Secondary Payer rules will be calculated in accordance with the established related payment rules. 40.1 - Single Payment Amount (Rev. 1532, Is sued: 06 -11-08, Effective: 07-01-08, Implementation: 07-07-08) The single payment amount for each competitively bid item in each CBA is based on the bids submitted and accepted for that item. Only bids from qualified suppliers (those that met all quality and financial standards and eligibility and accreditation requirements) are considered in setting the single payment amount. The single payment amount for an item furnished under the competitive bidding program is equal to the median of the bids submitte d for that item by qualified suppliers whose composite bids for the product category are equal to or below the pivotal bid for that product category. The single amount is determined by CMS and remains in effect for the duration of a contract period and is not adjusted for inflation. A listing of the single payment amounts will be posted at the CBIC Web site at http://www.dmecompetitivebid.com. See section 100.5 of chapter 23 of the Claims Processing Manual for instructions regarding adjustments to the single payment amounts as a result of changes in the HCPCS. 40.2 - Conditions for Payment (Rev. 1502; Issued: 05-09- 08; Effective/Implementation Date: 06 -09-08) Unless an exception is allowed (see section 20.6), Medicare does not make payment for any DMEPOS items and services subject to competitive bidding unless such items are furnished by a contract supplier for that item. 40.3 - Payment for Grandfathered Items Furnished During the Initial Competitive Bidding Contract Period/Program (Rev. 1502; Issued: 05- 09-08; Effective/Implementation Date: 06 -09-08) Payment for a grandfathered item(s) furnished during the initial competitive bidding contract period (i.e., when the item is bid for the first time in a CBA) varies depending on the payment category to which the item(s) belongs (See section 40.3.1 of this chapter). In all cases, assignment of claims is mandatory, and suppliers must accept the Medicare allowed payment amount as payment in full. 40.3.1 - Payment Categories (Rev. 1502; Issued: 05- 09-08; Effective/Implementation Date: 06 -09-08) 40.3.1.1 - Inexpensive or Routinely Purchased Items (Rev. 1502; Issued: 05- 09-08; Effective/Implementation Date: 06 -09-08) The standard provisions for determi ning the payment amount for inexpensive or routinely purchased items in section 30.1 of chapter 20 of this manual continue to apply when these items are furnished by grandfathered suppliers. Payment for the items is based on the lower of the actual charge or fee schedule amount for each item. 40.3.1.2 - Items Requiring Frequent and Substantial Servicing (Rev. 1502; Issued: 05- 09-08; Effective/Implementation Date: 06 -09-08) When items requiring frequent and substantial servicing are furnished by a grandfathered supplier, payment is based on the single payment amount established in accordance with 42 CFR 414.408(a)(1) for the CBA in which the beneficiary maintains a permanent residence. 40.3.1.3 - Oxygen and Oxygen Equipment (Rev. 1502; Issued: 05- 09-08; Effective/Implementation Date: 06 -09-08) When oxygen and oxygen equipment are furnished by a grandfathered supplier, payment is based on the single payment amount established in accordance with 42 CFR 414.408(a)(1) for the CBA in which the beneficiary maintains a permanent residence. 40.3.1.4 - Other DME or Capped Rental Items (Rev. 1502; Issued: 05- 09-08; Effective/Implementation Date: 06 -09-08) The standard payment provisions in section 30.5 of chapter 20 of this manual continue to apply when capped rental DME items are furnished by grandfathered suppliers. Payment for the items is ba sed on the lower of the actual charge or fee schedule amount for each item. 40.3.2 - Payment for Grandfathered Items Furnished During Subsequent Compe titive Bidding Contract Periods/Programs (Rev. 1502; Issued: 05- 09-08; Effective/Implementation Date: 06 -09-08) Payment for any grandfathered item furnished during a subsequent competitive bidding contract period (i.e., when an item is re -bid in a CBA a nd a new single payment amount is established) is based on the single payment amount for the round of competitive bidding during which the item is furnished and for the CBA in which the beneficiary maintains a permanent residence. 40.3.2.1 Payment for C apped Rental Items (Rev. 3593, Issued: 08- 17-16, Effective: 10- 01-16, Implementation: 10- 03-16) For rented, grandfathered equipment in the capped rental payment class (e.g., CPAP device or manual wheelchair), after the rental payment cap for the grandfathered equipment and after the rental payment cap on the accessory (when applicable, e.g., elevating leg rests) is reached, the beneficiary must obtain covered accessories and supplies (e.g., CPAP masks) only from a contract supplier. The supplier of the grandfathered equipment is no longer permitted to furnish the covered accessories and supplies once the rental payment cap on the grandfathered equipment is reached, with the exception of completing the rental period for accessories whose first month rental began during the rental period for the grandfathered equipment (e.g., the addition of elevating leg rests during the third rental month for a grandfathered manual wheelchair). 40.3.2.2 Payment for Inexpensive or Routinely Purchased Items (Rev. 3593, Issued: 08- 17-16, Effective: 10- 01-16, Implementation: 10- 03-16) For rented, grandfathered equipment in the inexpensive or routinely purchased payment class, after the total payments for the rented, grandfathered equipment (e.g., folding walker) rea ch the purchase fee schedule amount for the grandfathered equipment and after the rental payment cap on the accessory (when applicable), the beneficiary must obtain covered accessories (e.g., seat attachment) and supplies only from a contract supplier. The supplier of the grandfathered equipment is no longer permitted to furnish the covered accessories and supplies once the capped rental payment cap on the equipment is reached, with the exception of completing the rental period for accessories whose first month rental began during the rental period for the grandfathered equipment. 40.3.3 - Accessories and Supplies for Grandfathered Items (Rev. 1502; Issued: 05- 09-08; Effective/Implementation Date: 06 -09-08) Accessories and supplies that are used in conjunction with and are necessary for the effective use of a grandfathered item may be furnished by the same grandfathered supplier that furnishes the grandfathered item. Examples of medically necessary accessori es and supplies used in conjunction with DMEPOS items include tubes, hoses, and masks with respiratory equipment and administration sets with infusion pumps. Payment for these items to a grandfathered supplier is based on the single payment amount if the item is a competitive bid item for the CBA in which the beneficiary maintains a permanent residence (see 36.40.1 of chapter 20 in this manual). If the item is not a competitive bidding item, payment will be made in accordance with the standard payment rules. 40.4 - Payment for Rental of Inexpensive or Routinely Purchased DME (Rev. 1532, Issued: 06- 11-08, Effective: 07- 01-08, Implementation: 07- 07-08) The monthly rental payment amounts for inexpensive or routinely purchased DME (identified using HCPCS modifier RR) are equal to 10 percent of the single payment amount established for purchase of the item. 40.5 - Payment for Oxygen and Oxygen Equipment (Rev. 1532, Issued: 06- 11-08, Effective: 07- 01-08, Implementation: 07- 07-08) The monthly payment amounts for oxygen and oxygen equipment are equal to the single payment amounts established for the following classes of items: Stationary oxygen equipment (including stationary oxygen concentrators) and oxygen contents (stationary and portable) Portable equipme nt only (gaseous or liquid tanks) Oxygen generating portable equipment (OGPE) only (used in lieu of traditional portable oxygen equipment/tanks) Stationary oxygen contents (for beneficiary -owned stationary liquid or gaseous equipment) Portable oxygen contents (for beneficiary -owned portable liquid or gaseous equipment) In cases where a supplier is furnishing both stationary oxygen contents and portable oxygen contents, the supplier is paid both the single payment amount for stationary oxygen contents and the single payment amount for portable oxygen contents. The payment amounts for purchase of supplies and accessories used with beneficiary -owned oxygen equipment are equal to the single payment amounts established for the supply or accessory. 40.5.1 - Change in Suppliers for Oxygen and Oxygen Equipment (Rev. 3953, Issued: 01- 19-18, Effective: 07 -01-18, Implementation: 07- 02-18) The following rules apply when the beneficiary switches from one supplier of oxygen and oxygen equipment to another supplie r after the beginning of each round of competitive bidding: Noncontract supplier to contract supplier In general, monthly payment amounts may not exceed a period of continuous use of longer than 36 months. However, if the beneficiary switches from a noncontract supplier to a contract supplier before the end of the 36- month period, at least 10 monthly payment amounts would be made to a contract supplier that begins furnishing oxygen and oxygen equipment in these situations provided that medical necessity for oxygen continues.

(Medicare Claims Processing Manual)

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Stationary oxygen contents (for beneficiary -owned stationary liquid or gaseous equipment) Portable oxygen contents (for beneficiary -owned portable liquid or gaseous equipment) In cases where a supplier is furnishing both stationary oxygen contents and portable oxygen contents, the supplier is paid both the single payment amount for stationary oxygen contents and the single payment amount for portable oxygen contents. The payment amounts for purchase of supplies and accessories used with beneficiary -owned oxygen equipment are equal to the single payment amounts established for the supply or accessory. 40.5.1 - Change in Suppliers for Oxygen and Oxygen Equipment (Rev. 3953, Issued: 01- 19-18, Effective: 07 -01-18, Implementation: 07- 02-18) The following rules apply when the beneficiary switches from one supplier of oxygen and oxygen equipment to another supplie r after the beginning of each round of competitive bidding: Noncontract supplier to contract supplier In general, monthly payment amounts may not exceed a period of continuous use of longer than 36 months. However, if the beneficiary switches from a noncontract supplier to a contract supplier before the end of the 36- month period, at least 10 monthly payment amounts would be made to a contract supplier that begins furnishing oxygen and oxygen equipment in these situations provided that medical necessity for oxygen continues. For example, if a contract supplier begins furnishing oxygen equipment to a beneficiary in months 2 through 26, payment would be made for the remaining number of months in the 36-month period, because the number of payments to the contract supplier would be at least 10 payments. To provide a more specific example, a contract supplier that begins furnishing oxygen equipment beginning with the 20th month of continuous use would receive 17 payments (17 for the remaining number of months in the 36- month period). However, if a contract supplier begins furnishing oxygen equipment to a beneficiary in month 27 or later, no more than 10 monthly payments would be made assuming the oxygen equipment remains medically necessary. Contract supplie r to another contract supplier This rule does not apply when a beneficiary switches from a contract supplier to another contract supplier to receive his/her oxygen and oxygen equipment. In this scenario, the new contract supplier is paid based on the sing le payment amount for the remaining number of months in the 36-month period assuming the oxygen equipment remains medically necessary. Grandfathered item where there was a noncontract to contract supplier switch in a prior round This rule does not apply to grandfathered items in subsequent competitive bidding rounds when there was a previous noncontract to contract supplier switch in the prior round and the same supplier has elected to continue furnishing the oxygen equipment. In this case, the grandfat hered supplier would be eligible to continue billing for the remaining number payments left in the oxygen rental period at the start of the competitive bidding round. The maximum number of monthly rental payments may not exceed 45 rental payments. 40.6 - Payment for Capped Rental DME Items (Rev. 1532, Issued: 06- 11-08, Effective: 07- 01-08, Implementation: 07- 07-08) The monthly rental payment amounts for capped rental DME (identified using HCPCS modifier RR) are equal to 10 percent of the single payment amount established for purchase of the item for each of the first 3 months and 7.5 percent of the single payment amount established for purchase of the item for months 4 through 13. 40.6.1 - Change in Suppliers for Capped Rental DME Items (Rev. 1532, Issued: 06 -11-08, Effective: 07- 01-08, Implementation: 07- 07-08) The following rules apply when the beneficiary switches from one supplier of capped rental DME to another supplier after the beginning of each round of competitive bidding: Noncontract supplier to contract supplier In general, rental payments may not exceed a period of continuous use of longer than 13 months. However, if the beneficiary switches from a noncontract supplier to a contract supplier before the end of the 13- month rental period, a new 13- month period begins and payment is made on the basis of the single payment amounts described in section 40.6. The contract supplier that the beneficiary switches to is responsible for furnishing the item until medical necessity ends, or the 13-month period of continuous use ends, whichever is earlier. On the first day following the end of the new 13- month rental period, the contract supplier is required to transfer title of the capped rental item to the beneficiary. Once the beneficiary switches from a noncontract supplier to a contract supplier, they may not switch back to a noncontract supplier if he/she continues to maintain a permanent residence in a CBA. If, however, the beneficiary relocates out of the CBA to a non- CBA, then he/she may sw itch to a noncontract supplier and a new 13- month rental period does not begin. See section 40.3 for instructions for payment of grandfathered items. Contract supplier to another contract supplier If the beneficiary switches from a contract supplier to a contract supplier before the end of the 13-month rental period, a new 13- month period does not begin. This provision applies in situations where the beneficiary changes suppliers within a CBA and in situations where the beneficiary relocates and switches from a contract supplier in one CBA to contract supplier in another CBA. The contract supplier that the beneficiary switches to is responsible for furnishing the item until medical necessity ends, or the 13 -month period of continuous use ends, whichever is earlier. On the first day following the end of the 13 -month rental period of continuous use, the contract supplier is required to transfer title of the capped rental item to the beneficiary. 40.7 - Payment for Purchased Equipment (Rev. 1532, Issued: 06- 11-08, Effective: 07- 01-08, Implementation: 07- 07-08) The payment amount for the purchase of new equipment (identified using HCPCS modifier NU), including inexpensive or routinely purchased DME, power wheelchairs, and enteral nutrition equipment, is equal to 100 percent of the single payment amounts established for these items. This payment amount for the purchase of used equipment (identified using HCPCS modifier UE), including inexpensive or routinely purchased DME, power wheelchairs, and enteral nutrition equipment, is equal to 75 percent of the single payment amounts established for new purchase equipment items. 40.8 - Payment for Repair and Replacement of Beneficiary -Owned Equipment (Rev. 3593, Issued: 08- 17-16, Effective: 10- 01-16, Implementation: 10- 03-16) Beneficiaries who maintain a permanent residence in a CBA may go to any Medicare- enrolled supplier (contract or noncontract supplier) for the maintenance or repair of beneficiary -owne d equipment, including parts that need to be replaced in order to make the equipment serviceable. Labor to repair equipment is not subject to competitive bidding and, therefore, will be paid in accordance with Medicares general payment rules. Payment fo r replacement parts that are part of the competitive bidding program for the area in which the beneficiary resides is based on the single payment amount for that replacement part in the CBA in which the beneficiary lives. Payment is not made for parts and labor covered under a manufacturers or suppliers warranty. Beneficiaries must obtain replacements of beneficiary -owned competitively bid items that are part of the competitive bidding program for the areas in which the beneficiary resides from a contract supplier unless the item is a replacement part or accessory that is replaced as part of the service of repairing beneficiary -owned base equipment (e.g., wheelchair, walker, hospital bed, continuous positive pressure airway device, oxygen concentrator, etc.). All base equipment that is replaced in its entirety because of a change in the beneficiarys medical condition or because the base equipment the beneficiary was using was either lost, stolen, irreparably damaged, or used beyond the equipments reasonable useful lifetime (see section 110.2.C of chapter 15 of the Benefit Policy Manual) must be obtained from a contract supplier in order to receive Medicare payment. The contract supplier is not required to replace an entire competitively bid item with the same make and model as the previous item unless a physician or treating practitioner prescribes that make and model. (See section 30.4 of this chapter.). If beneficiary -owned oxygen equipment or capped rental DME that is a competitively bid item for the CBA in which the beneficiary maintains a permanent residence has to be replaced prior to end of its reasonable useful lifetime, then the replacement item must be furnished by the supplier (contract or noncontract supplier) that transferred ownership of the item to the beneficiary. Payment for replacement of items that are part of the competitive bidding program for the area in which the beneficiary resides is based on the single payment amount for that item. For additional information regarding payment of a part of a DMEPOS Item, please see Pub.100-04 chapter 20, section 50.5. 40.9 - Payment for Rental Enteral Nutrition Equipment (Rev. 1532, Issued: 06- 11-08, Effective: 07- 01-08, Implementation: 07- 07-08) The monthly rental payment amounts for enteral nutrition equipment (identified using HCPCS modifier RR) are e qual to 10 percent of the single payment amount established for purchase of the item for each of the first 3 months and 7.5 percent of the single payment amount established for purchase of the item for months 4 through 15. 40.9.1 - Maintenance and Servici ng of Enteral Nutrition Equipment (Rev. 1532, Issued: 06- 11-08, Effective: 07- 01-08, Implementation: 07- 07-08) The contract supplier that furnishes the equipment to the beneficiary in the 15th month of the rental period must continue to furnish, maintain, and service the equipment after the 15 month rental period is completed until a determination is made by the beneficiarys physician or treating practitioner that the equipment is no longer medically necessary. The payment for maintenance and servicing enteral nutrition equipment is 5 percent of the single payment amount established for purchase of the item . 40.10 - Traveling Beneficiaries (Rev. 1532, Issued: 06- 11-08, Effective: 07-01-08, Implementation: 07-07-08) Beneficiaries may travel, for example, to visit family members or reside in a State with warmer climates during winter months. As a result, beneficiaries will need to consider the following three factors when traveling: (1) where to go to obtain a DMEPOS item; (2) identify whether the item is a competitively bid item or not; and (3) determine the Medicare payment amount for that item. Depending on where the beneficiary travels (whether to a CBA or a non-CBA), the beneficiary may need to obtain DMEPOS from a contract supplier in order for Medica re to cover the item. For example, a beneficiary who travels to a non -CBA may obtain DMEPOS, if medically necessary, from any Medicare-enrolled supplier. On the other hand, a beneficiary who travels to a CBA should obtain competitively bid items in that C BA from a contract supplier in that CBA in order for Medicare to cover the item. The chart below shows whether a beneficiary should go to a contract supplier or any Medicare- enrolled supplier when the beneficiary travels. Beneficiary Permanently Resides Travels to Type of Supplier a CBA a CBA The beneficiary should obtain competitively bid items in that CBA from a contract supplier located in that CBA if the beneficiary wants Medicare to cover the item. a non -CBA Medicare will cover DMEPOS, if medically necessary, from any Medicare -enrolled DMEPOS supplier. Non-CBA a CBA The beneficiary should obtain the competitively bid item from a contract supplier in the CBA if the beneficiary wants Medicare to cover the item. Non-CBA Medicare -enrolled DMEPOS supplier Suppliers that furnish DMEPOS items to Medicare beneficiaries who maintain a permanent residence in a CBA and who travel to a non-CBA need to be aware of the public use files on the CBIC Web site at: http://www.dmecompetitivebid.com/palmetto/cbic.nsf/DocsCat/Home. The public use files contain the ZIP Codes for the CBAs, the HCPCS for competitively bid items, and the single payment amounts for these items. Suppl iers will be able to use these files to identify if the beneficiary traveling to the area maintains a permanent residence in a CBA, determine whether the beneficiary is obtaining a competitively bid item, and determine the single payment amount for those i tems. The Medicare payment amount is always based on the location in which the beneficiary maintains a permanent residence. For example: a. If a beneficiary maintains a permanent residence in a CBA and travels outside of the CBA, payment for a competitively bid item for the CBA in which the beneficiary maintains a permanent residence is the single payment amount for that item in the beneficiarys CBA.

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a CBA The beneficiary should obtain the competitively bid item from a contract supplier in the CBA if the beneficiary wants Medicare to cover the item. Non-CBA Medicare -enrolled DMEPOS supplier Suppliers that furnish DMEPOS items to Medicare beneficiaries who maintain a permanent residence in a CBA and who travel to a non-CBA need to be aware of the public use files on the CBIC Web site at: http://www.dmecompetitivebid.com/palmetto/cbic.nsf/DocsCat/Home. The public use files contain the ZIP Codes for the CBAs, the HCPCS for competitively bid items, and the single payment amounts for these items. Suppl iers will be able to use these files to identify if the beneficiary traveling to the area maintains a permanent residence in a CBA, determine whether the beneficiary is obtaining a competitively bid item, and determine the single payment amount for those i tems. The Medicare payment amount is always based on the location in which the beneficiary maintains a permanent residence. For example: a. If a beneficiary maintains a permanent residence in a CBA and travels outside of the CBA, payment for a competitively bid item for the CBA in which the beneficiary maintains a permanent residence is the single payment amount for that item in the beneficiarys CBA. b. When a beneficiary maintains a permanent residence in an area that is not in a CBA and travels to CBA or non- CBA, the supplier that furnishes the item will be paid the fee schedule amount for the area where the beneficiary maintains a permanent residence. 40.10.1 - Traveling Beneficiaries and Transfer of Title of Oxygen Equipment or Capped Rental Items (Rev. 1532, Issued: 06- 11-08, Effective: 07-01-08, Implementation: 07-07-08) If a beneficiary has two residences in different areas and uses a local supplier in each area or if a beneficiary changes suppliers during or after the rental period, this does not result in a new rental episode. The supplier that provides the item in the 36th month of a rental episode for oxygen equipment or the 13th month of a rental episode for capped rental DME is responsible for transferring title to the equipment to the beneficiary . This applies to snow bird or extended travel patients and coordinated services for patients who travel after they have purchased the item. 40.11 - Billing Procedures Related to Advance Beneficiary Notice (ABN) Upgrades under the Competitive Bidding Pr ogram (Rev. 1532, Issued: 06- 11-08, Effective: 07-01-08, Implementation: 07-07-08) In general, an item included in a competitive bidding program must be furnished by a contract supplier for Medicare to make payment. This requirement applies to situations where the item is furnished directly or indirectly as an upgrade. An upgrade is an item with features that go beyond what is medically necessary. An upgrade may include an excess component. An excess component may be an item feature or service, which is in addition to, or is more extensive than, the item that is reasonable and necessary under Medicare coverage requirements. An item is indirectly furnished if Medicare makes payment for it because it is medically necessary and is furnished as part of an upgraded item. The billing instructions for upgraded equipment found in section 120 of chapter 20 of the Medicare Claims Processing Manual (Pub. 100 -04) continue to apply under the DMEPOS Competitive Bidding Program. The following scenarios and chart des cribe situations where a beneficiary, residing in a competitive bidding area, elects to upgrade to an item with features or upgrades that are not medically necessary. Upgrades from a bid item to a non- bid item In this situation, Medicare payment will only be made to a contract supplier on an assignment -related basis. Medicare payment will be equal to 80 percent of the single payment amount for the medically necessary bid item. Upgrades from a non- bid item to a bid item When upgrading from a non- bid to a bid item, Medicare payment is made to a contract supplier on either an assigned or unassigned basis. Medicare payment will be equal to 80 percent of the lower of the actual charge or the fee schedule amount for the medically necessary non -bid item. Upgrades from a bid item in one product category (category S) to a bid item in another product category (category U) In this case, Medicare payment is only made to a contract supplier for the product category U on an ass ignment-related basis. Medicare payment would be equal to 80 percent of the single payment amount for the medically necessary bid item in product category S. Upgrade Scenarios for Beneficiaries Residing in a Competitive Bidding Area (CBA) From the Medically Necessary Item To the Upgraded Item Must be Furnished by Assignment Mandatory (Y/N) Medicare Payment Based Upon Bid Item Non-Bid Item Contract Supplier Y Single Payment Amount for the Medically Necessary Item Non-Bid Item Bid Item Contract Supplier N Lower of the Actual Charge or Fee Schedule Amount for the Medically Necessary Item Bid Item in Product Category S Bid Item in Product Category U Contract Supplier for Category U Y Single Payment Amount for Category S for the Medically N ecessary Item The following scenarios and chart describe situations where a beneficiary, who does not reside in a competitive bidding area, but travels to a competitive bidding area, elects to upgrade to an item with features that are not medically neces sary. Upgrades from a bid item to a non- bid item In this situation, Medicare payment is only made to a contract supplier on an assignment-related basis. Medicare payment will be equal to 80 percent of the lower of the actual charge or the fee schedule amount for the medically necessary bid item. Upgrades from a non- bid item to a bid item When upgrading from a non- bid to a bid item, Medicare payment is made to a contract supplier on either an assigned or unassigned basis. Medicare payment will be equal to 80 percent of the lower of the actual charge or the fee schedule amount for the medically necessary non -bid item. Upgrades from a bid item in one product category (category S) to a bid item in another product category (category U) In this case, Medicare payment is only made to a contract supplier for the product category U on an assignment -related basis. Medicare payment would be equal to 80 percent of lower of the actual charge or the fee schedule amount for the medically necess ary bid item in product category S. Upgrade Scenarios for Beneficiaries Who Do Not Reside In a CBA, But Travel to a CBA From the Medically Necessary Item To the Upgraded Item Must be Furnished by Assignment Mandatory (Y/N) Medicare Payment Based Upon Bid Item Non-Bid Item Contract Supplier Y Lower of the Actual Charge or Fee Schedule Amount for the Medically Necessary Item Non-Bid Item Bid Item Contract Supplier N Lower of the Actual Charge or Fee Schedule Amount for the Medically Necessary Item Bid Item in Product Category S Bid Item in Product Category U Contract Supplier for Category U Y Lower of the Actual Charge or Fee Schedule Amount for the Medically Necessary Item Beneficiary Liability under the Competitive Bidding Program Under the competitive bidding program, a beneficiary has no financial liability to a non contract supplier that furnishes an item included in the competitive bidding program for a competitive bidding area, unless, prior to receiving the item, the beneficiary selects Option 1 on the ABN and signs the notice. Similarly, beneficiaries who receive an upgraded item from a non -contract supplier in a competitive bidding area are not financially liable for the item unless, prior to giving the beneficiary the upgraded item, the supplier obtains a valid ABN on which the enrollee has selected Option 1 and signed the notice. In the case of upgrades, for a beneficiary to be liable for the extra cost of an item that exceeds their medical needs, the beneficiary must, select Option 1 and sign a valid ABN prior to receiving the item. See Chapter 20, section 120 of the Medicare Claims Processing Manual for additional information on ABN upgrades. 40.12 - Billing Procedures Related to Downcoding under the Competitive Bidding Program (Rev. 1532, Issued: 06- 11-08, Effective: 07-01-08, Implementation: 07-07-08) The following downcoding guidelines describe situations where Medicare reduces the level of payment for the prescribed item based on a medical necessity partial denial of coverage for the additional, not medically necessary, expenses associated with the prescribed item. For beneficiaries who reside in a CBA and for whom Medicare determines that the prescribed item should be downcoded to an item that is reasonable and necessary unde r Medicares coverage requirements, the subsequent scenarios and chart detail the type of supplier that can furnish the item and the payment for the item. Downcodes from a non- bid item to a bid item In this situation, Medicare payment will be made to any Medicare enrolled supplier on an assigned or unassigned basis. Medicare payment will be equal to 80 percent of the single payment amount for the medically necessary bid item. Downcodes from a bid item to a non- bid item Medicare payment in this downcoding scenario will be made to a contract supplier on an assignment -related basis. Medicare payment will be equal to 80 percent of the lower of the actual charge or the fee schedule amount for the medically necessary non -bid item. Downcodes from a bid item in one product category (category U) to a bid item in another product category (category S) In this case, Medicare payment will be made to a contract supplier for the product category U on an assignment -related basis. Medicare payment would be equal t o 80 percent of the single payment amount for the medically necessary bid item in product category S. Downcoding Scenarios for Beneficiaries Residing in a CBA From a Higher Level of Service Item To a Medically Necessary Item Must be Furnished by Assignment Mandatory (Y/N) Medicare Payment Based Upon Non-Bid Item Bid Item Any Medicare Enrolled Supplier N Single Payment Amount for the Medically Necessary Item Bid Item Non-Bid Item Contract Supplier Y Lower of the Actual Charge or Fee Schedule Amount for the Medically Necessary Item Bid Item in Product Category U Bid Item in Product Category S Contract Supplier for Category U Y Single Payment Amount for Category S for the Medically Necessary Item The following scenarios and chart desc ribe situations where the prescribed item for a beneficiary that does not reside in a CBA, but travels to a CBA is downcoded to an item that is reasonable and necessary under Medicares coverage requirements. Downcodes from a non- bid item to a bid item In this situation, Medicare payment will be made to any Medicare enrolled supplier on an assigned or unassigned basis. Medicare payment will be equal to 80 percent of the lower of the actual charge or the fee schedule amount for the medically necessary bi d item. Downcodes from a bid item to a non- bid item Medicare payment in this downcoding scenario will only be made to a contract supplier on an assignment- related basis. Medicare payment will be equal to 80 percent of the lower of the actual charge or the fee schedule amount for the medically necessary non -bid item. Downcodes from a bid item in one product category (category U) to a bid item in another product category (category S) In this case, Medicare payment will only be made to a contract suppli er for the product category U on an assignment -related basis. Medicare payment will be equal to 80 percent of the lower of the actual charge or the fee schedule amount for the medically necessary bid item in product category S. Downcoding Scenarios for Beneficiaries Who Do Not Reside In a CBA, But Travel to a CBA From a Higher Level of Service Item To a Medically Necessary Item Must be Furnished by Assignment Mandatory (Y/N) Medicare Payment Based Upon Non-Bid Item Bid Item Any Medicare Enrolled Supplier N Lower of the Actual Charge or Fee Schedule Amount for the Medically Necessary Item Bid Item Non-Bid Item Contract Supplier Y Lower of the Actual Charge or Fee Schedule Amount for the Medically Necessary Item Bid Item in Product Category U Bid Item in Product Category S Contract Supplier for Category U Y Lower of the Actual Charge or Fee Schedule Amount for the Medically Necessary Item

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Downcodes from a bid item in one product category (category U) to a bid item in another product category (category S) In this case, Medicare payment will only be made to a contract suppli er for the product category U on an assignment -related basis. Medicare payment will be equal to 80 percent of the lower of the actual charge or the fee schedule amount for the medically necessary bid item in product category S. Downcoding Scenarios for Beneficiaries Who Do Not Reside In a CBA, But Travel to a CBA From a Higher Level of Service Item To a Medically Necessary Item Must be Furnished by Assignment Mandatory (Y/N) Medicare Payment Based Upon Non-Bid Item Bid Item Any Medicare Enrolled Supplier N Lower of the Actual Charge or Fee Schedule Amount for the Medically Necessary Item Bid Item Non-Bid Item Contract Supplier Y Lower of the Actual Charge or Fee Schedule Amount for the Medically Necessary Item Bid Item in Product Category U Bid Item in Product Category S Contract Supplier for Category U Y Lower of the Actual Charge or Fee Schedule Amount for the Medically Necessary Item 50 - Special Billing Instructions for the DMEPOS Competitive Bidding Program (Rev. 11427; Issued: 05-20- 22; Effective: 01 -01-23; Implementation: 01-03-23) NOTE: CMS seeks to reduce burden and modernize processes to ensure a reduction in improper payments and an increase in customer satisfaction. The Certificate of Medical Necessity (CMN) form and DME Information Form (DIF) were originally required to help document the medical necessity and other coverage criteria for selected Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) items. In the past, a supplier received a signed CMN from the treating physician or created and signed a DIF to submit with the claim. Due to improvements in claims processing and medical records management, the information found on CMNs or DIFs is available either on the claim or in the medical record and is redundant. Therefore, to reduce burden and increase customer satisfaction, providers and suppliers no longer need to submit these forms for services rendered 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. F or claims with dates of service prior to January 1, 2023 processes will not change and if the CMN or DIF is required, it will still need to be submitted with the claim, or be on file with a previous claim. This statement applies throughout the Program Integrity Manual wherever CMNs and DIFs are mentioned. Claims for competitively bid items shall be submitted under the general DMEPOS claims billing guidelines specified in Chapter 20, 110 of the Medicare Claims Processing Manual, with the following exceptions described in this section. 50.1 - Electronic Submission of Claims and Mandatory Assignment (Rev. 2979, Issued: 06- 27-14, Effective: 01-01-12, Implementation: 07-28-14) Under the DMEPOS Competitive Bidding Program, all claims shall be submitted electronically using the ASC X12 837 profe ssional claim format except for MSP claims. ( NOTE: Claims with multiple MSP situations may be submitted on a paper claim.) Exceptions to the mandatory electronic billing requirement granted under the Administrative Simplification Compliance Act (ASCA) do not apply to DMEPOS Competitive Bidding claims. All DMEPOS Competitive Bidding Program claims are subject to mandatory assignment. Mandatory assignment denotes that a supplier shall accept the Medicare payment as payment in full for their services. The beneficiarys liability is limited to any applicable deductible plus the 20 percent coinsurance. For additional information concerning mandatory assignment of claims, see Chapter 1, 30.3.1 of the Medicare Claims Processing Manual. 50.2 - New Modifiers f or DMEPOS Competitive Bidding Billing (Rev. 1544, Issued: 06- 26-08, Effective: 07-01-08, Implementation: 07-07-08) Table 1 below describes the modifiers implemented for the DMEPOS Competitive Bidding Program. Specific instructions for the use of each modifier for billing are included in subsequent subsections. Table 1: Modifiers Implemented for DMEPOS Competitive Bidding Billing Modifier Effective Date Definition KG 7/1/07 DMEPOS Item Subject to DMEPOS Competitive Bidding Program Number 1 KK 7/1/07 DMEPOS Item Subject to DMEPOS Competitive Bidding Program Number 2 Modifier Effective Date Definition KU 7/1/07 DMEPOS Item Subject to DMEPOS Competitive Bidding Program Number 3 KL 7/1/07 DMEPOS Item Delivered Via Mail KT 7/1/07 Beneficiary Resides in a Competitive Bidding Area and Trav els Outside that Competitive Bidding Area and Receives a Competitive Bid Item KV 1/1/08 DMEPOS Item Subject to DMEPOS Competitive Bidding Program that is Furnished as Part of a Professional Service KW 1/1/08 DMEPOS Item Subject to DMEPOS Competitive Bidding Program Number 4 KY 1/1/08 DMEPOS Item Subject to DMEPOS Competitive Bidding Program Number 5 50.3 - Billing for Items in Multiple Product Categories (Rev. 2231, Issued: 05- 27-11, Effective: 08-28-11, Implementation: 08-28-11) New HCPCS modifiers were developed to facilitate implementation of various policies that apply to certain competitive bidding items. The KG, KK, KU, KW, and KY modifiers are pricing modifiers that suppliers must use to identify when the same supply or accessory HCPC S code is furnished in multiple competitive bidding product categories. For example, HCPCS code E0981 (Wheelchair Accessory, Seat Upholstery, Replacement Only, Each) is found in both the standard and complex rehabilitative power wheelchair competitive bidd ing product categories. Contract suppliers for the standard power wheelchair product category shall submit E0981 claims using the KG modifier, whereas contract suppliers for the complex rehabilitative power wheelchair product category shall use the KK modifier. All suppliers, including grandfathered suppliers, shall submit claims for competitive bid items using the aforementioned competitive bidding modifiers. The KG and KK modifiers are used in Round I of the competitive bidding program and the KU and KW m odifiers are reserved for future program use. 50.4 - Claims Jurisdiction and Billing Procedures for Traveling Beneficiaries (Rev. 1544, Issued: 06- 26-08, Effective: 07-01-08, Implementation: 07-07-08) Claims for non- mail order competitively bid items fur nished to beneficiaries who maintain a permanent residence in a CBA, but who are traveling outside of their CB when they obtain the item, must be submitted with a KT modifier to indicate a traveling beneficiary. Claims for competitively bid items furnis hed to beneficiaries who obtain the item outside of their CBA that do not have a KT modifier shall be denied. Jurisdiction for these claims remains with DME MAC with jurisdiction for the beneficiary based on the beneficiarys permanent residence. Claims for mail order competitively bid items that have a KT modifier shall be denied. 50.5 - Claims for DMEPOS Items Furnished to a Beneficiary by a Skilled Nursing Facility (SNF) or Nursing Facility (NF) (Rev. 1544, Issued: 06- 26-08, Effective: 07-01-08, Im plementation: 07 -07-08) For purposes of claims adjudication under DMEPOS Competitive Bidding, beneficiaries who maintain a permanent residence in a CBA and, while a resident of a SNF or NF outside of a CBA, obtain a competitively bid item from that SNF or NF are treated as traveling beneficiaries when their permanent address is within a CBA. As a result, the SNF or NF shall submit a KT modifier on any claims for competitively bid items furnished to beneficiaries, under these circumstances. A claim must include a place of service 31 to indicate that the beneficiary resides in a SNF or 32 to indicate that the beneficiary resides in a NF, as applicable. See 20.5.2 for the policies applicable to SNFs and NFs that furnish competitively bid items under D MEPOS Competitive Bidding Program. 50.6 - Billing for Mail Order Items (Rev. 1544, Issued: 06- 26-08, Effective: 07- 01-08, Implementation: 07- 07-08) The KL modifier has been established for use in submitting claims for mail order DMEPOS items (e.g., dia betic supplies). Beneficiaries who maintain a permanent residence in CBAs for which there is a competitive bidding program for mail order diabetic supplies may choose to obtain their diabetic supplies through mail order or at a storefront. A beneficiary w ho resides in a CBA and chooses to obtain their diabetic supplies through mail order must obtain these supplies from a contract supplier for mail order diabetic supplies for the CBA where they maintain a permanent residence. Claims for mail order diabetic supplies furnished to beneficiaries who maintain a permanent residence in a CBA must be billed with the modifier KL. If the beneficiary chooses to obtain their diabetic supplies at a storefront, DMEPOS competitive bidding rules do not apply and these c laims will be processed under the normal guidelines for supply claims. See 20.5.3 for additional information on mail -order contract suppliers of diabetic supplies. 50.7 - Claims Submitted for Physicians and Treating Practitioners Who Furnish Competitive ly Bid Items (Rev. 1544, Issued: 06- 26-08, Effective: 07- 01-08, Implementation: 07- 07-08) Under DMEPOS Competitive Bidding, physicians and treating practitioners may furnish certain competitively bid items without submitting a bid and being awarded a cont ract. This exception requires that the items be furnished by the physician or treating practitioner to his or her own patients as part of his or her professional service. The professional service must be furnished on the same date as the date that the DME item is initially furnished. In addition, physicians and treating practitioners must submit their office visit claim on the same day that they submit the DME claim to ensure timely and accurate claims processing. Physicians and treating practitioners who provide DME items in their offices shall continue to be paid even though they are not a contract supplier for the items. See 20.6 for additional information. Physicians and treating practitioners that are located in a CBA must submit the KV modif ier on claims for competitively bid items and related accessories that are furnished in accordance with this exception to receive payment for these items for the CBA where the beneficiary maintains a permanent residence. Physician and treating practitioner submitted competitive bidding claims that do not have an accompanying office visit will be denied. Physicians and treating practitioners located outside a CBA who furnish DME competitively bid items and/or related accessories as part of a professional s ervice to traveling beneficiaries who maintain a permanent residence in a CBA must also affix the KV modifier to claims submitted for these items. 50.8 - Billing for Oxygen and Oxygen Equipment (Rev. 1544, Issued: 06- 26-08, Effective: 07- 01-08, Implementation: 07 -07-08) Noncontract suppliers of oxygen and oxygen equipment may elect to become grandfathered suppliers and continue furnishing these items and services to beneficiaries after the start of the DMEPOS Competitive Bidding Program, if th e beneficiary agrees to the arrangement. This grandfathering process only applies to suppliers that began furnishing oxygen and oxygen equipment to beneficiaries in a CBA prior to the implementation of the competitive bidding program for that area and cho ose to continue to furnish the grandfathered oxygen and oxygen equipment to these same beneficiaries in the CBA after the start of the DMEPOS Competitive Bidding Program. See 20.6 for additional information on payments to noncontract suppliers. If a noncontract supplier does not want to continue furnishing oxygen and oxygen equipment to its existing customers/beneficiaries, the beneficiaries must use a contract supplier to obtain the oxygen and oxygen equipment. Ordinarily, the title to the oxygen equipment would transfer to the beneficiary after rental payments have been made for 36 months of continuous use. However, Medicare allows for a minimum of 10 months of payments to be made to a contract supplier for oxygen and oxygen equipment furnished to a beneficiary who changes suppliers under the DMEPOS Competitive Bidding Program because the current supplier chose not to become a grandfathered supplier. Therefore, under the DMEPOS Competitive Bidding Program, up to 45 continuous payments could be made fo r the oxygen and oxygen equipment. The beneficiary is liable for co -payments for all paid oxygen and oxygen equipment claims.

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If a noncontract supplier does not want to continue furnishing oxygen and oxygen equipment to its existing customers/beneficiaries, the beneficiaries must use a contract supplier to obtain the oxygen and oxygen equipment. Ordinarily, the title to the oxygen equipment would transfer to the beneficiary after rental payments have been made for 36 months of continuous use. However, Medicare allows for a minimum of 10 months of payments to be made to a contract supplier for oxygen and oxygen equipment furnished to a beneficiary who changes suppliers under the DMEPOS Competitive Bidding Program because the current supplier chose not to become a grandfathered supplier. Therefore, under the DMEPOS Competitive Bidding Program, up to 45 continuous payments could be made fo r the oxygen and oxygen equipment. The beneficiary is liable for co -payments for all paid oxygen and oxygen equipment claims. 50.9 - Billing for Capped Rental DME Items (Rev. 1544, Issued: 06- 26-08, Effective: 07- 01-08, Implementation: 07- 07-08) Noncont ract suppliers of capped rental DME equipment may elect to become grandfathered suppliers and continue furnishing equipment to their existing beneficiaries after the start of the DMEPOS Competitive Bidding Program, if the beneficiary agrees to the arrang ement. This grandfathering process only applies to suppliers that began furnishing the capped rental DME item to beneficiaries in a CBA prior to the implementation of the competitive bidding program for that area and choose to continue to furnish the grandfathered item to these same beneficiaries in the CBA after the start of the DMEPOS Competitive Bidding Program. See 20.6 for additional information on payments to noncontract suppliers. If a noncontract supplier does not want to continue furnishing capp ed rental DME to its existing customers/beneficiaries after the start of the DMEPOS Competitive Bidding Program, the beneficiary must use a contract supplier to obtain the item. Ordinarily, the title to the capped rental DME item would transfer to the bene ficiary after rental payments have been made for 13 months of continuous use. However, for beneficiaries that switch from a noncontract supplier to a contract supplier, the 13 month capped rental period starts over again. In this case, Medicare allows for a minimum of 13 months of rental payments to be made to a contract supplier because their current supplier chose not to become a grandfathered supplier. Therefore, under DMEPOS Competitive Bidding Program, when a beneficiary switches from a noncontract s upplier to a contract supplier, up to 25 continuous payments could be made for the capped rental DME item. The beneficiary is liable for co -payments for all paid capped rental DME equipment claims. 50.9.1 - Certificates of Medical Necessity (CMN) and Cap ped Rental Billing (Rev. 1544, Issued: 06- 26-08, Effective: 07- 01-08, Implementation: 07- 07-08) Suppliers are not required to obtain a new Certificate of Medical Necessity (CMN) for situations in which a beneficiary who was receiving a capped rental item prior to the implementation of DMEPOS Competitive Bidding goes to a new supplier after the implementation of the DMEPOS Competitive Bidding Program (e.g., the previous supplier decides not to become a grandfathered supplier), unless the beneficiarys medic al necessity for the item has changed. Notwithstanding this situation, the new supplier shall bill using the appropriate modifiers for their first rental month (KH), the second and third rental months (KI), and all subsequent rental months (KJ). 50.10 - Claims Submitted for Hospitals Who Furnish Competitively Bid Items (Rev. 2231, Issued: 05- 27-11, Effective: 08- 28-11, Implementation: 08- 28-11) Under DMEPOS Competitive Bidding, hospitals may furnish certain types of competitively bid DME to their patients on the date of discharge without submitting a bid and being awarded a contract. The DME items that a hospital may furnish as part of the exception are limited to: crutches, canes, walkers, folding manual wheelchairs, blood glucose monitors, and i nfusion pumps. Payment for items furnished under this exception will be made based on the single payment amount for the item for the CBA where the beneficiary resides. Separate payment is not made for walkers and related accessories furnished by a hospit al on the date of admission because payment for these items is included in the Part A payment for inpatient facility services. Refer to Pub. 100- 04, the Medicare Claims Processing Manual, Chapter 1, 10.1.1.1 for instructions for submitting claims. 50.11 - Claims Submitted for Medicare Beneficiaries Previously Enrolled in a Medicare Advantage Plan (Rev. 2231, Issued: 05- 27-11, Effective: 08- 28-11, Implementation: 08- 28-11) Under DMEPOS Competitive Bidding, if a beneficiary resides in a CBA and elects to leave their MA plan or loses his/her coverage under this plan, the beneficiary may continue to receive items requiring frequent and substantial servicing, capped rental, oxygen and oxygen equipment, or inexpensive or routinely purchased rented items from t he same DME supplier under the MA plan without going to a contract supplier under the Medicare DMEPOS Competitive Bidding Program. However, the supplier from whom the beneficiary previously received the item under the plan must be a Medicare enrolled supplier; meet the Medicare FFS coverage criteria and documentation requirements; and must elect to become a grandfathered supplier. All competitive bid grandfathering rules apply in these situations. 50.12 - Claims for Repairs and Replacements (Rev. 2231, I ssued: 05 -27-11, Effective: 08- 28-11, Implementation: 08- 28-11) Under the DMEPOS Competitive Bidding Program, any DMEPOS supplier, provided they have a valid Medicare billing number, can furnish and bill for services (labor and parts) associated with the repair of DME or enteral nutrition equipment owned by beneficiaries who reside in a CBA. In these situations, Medicare payment for labor will be made based on the standard payment rules. Medicare payment for claims for replacement parts associated with r epairing competitively bid DME or enteral nutrition equipment, that are submitted with the RB modifier, will be based on the single payment amount for the part if the part and equipment being repaired are included in the same competitive bidding product ca tegory in the CBA. Otherwise, Medicare payment for replacement parts associated with repairing equipment owned by the beneficiary will be made based on the standard payment rules. The replacement of an entire item, as opposed to the replacement of a part for repair purposes, which is subject to the DMEPOS Competitive Bidding Program, must be furnished by a contract supplier. Medicare payment for the replacement item would be based on the single payment amount for the item in the beneficiarys CBA. Refer to Pub. 100- 04, the Medicare Claims Processing Manual, Chapter 20, 10.2 for instructions on submitting claims for repairs and replacements. 50.13 - Billing for Oxygen Contents to Suppliers After the 36th Month Rental Cap (Rev. 2231, Issued: 05- 27-11, Eff ective: 08 -28-11, Implementation: 08- 28-11) The Medicare law requires that the supplier that furnishes liquid or gaseous oxygen equipment (stationary or portable) for the 36th continuous month must continue to furnish the oxygen contents necessary for the effective use of the liquid or gaseous equipment during any period after the payment cap and of medical need for the remainder of the reasonable useful lifetime established for the equipment. This requirement continues to apply under the Medicare DMEPOS Competitive Bidding Program, regardless of the role of the supplier (i.e., contract supplier, grandfathered supplier, or non- contract supplier) and the location of the beneficiary (i.e. residing within or outside a CBA). Should a beneficiary travel or tem porarily relocate to a CBA, the oxygen supplier that received the payment for the 36th continuous month must make arrangements for furnishing oxygen contents with a contract supplier in the CBA in the event that the supplier that received the 36th month pa yment elects to make arrangements for a temporary oxygen contents billing supplier. The Medicare payment amount is always based on the location in which the beneficiary maintains a permanent residence. If the beneficiary resides in a CBA, payment for the oxygen contents will be based on the single payment amount for that CBA. If the beneficiary resides outside of a CBA and travels to a CBA, payment for the oxygen contents will be based on the fee-schedule amount for the area where the beneficiary maintai ns a permanent residence. 50.14 - Purchased Accessories & Supplies for Use With Grandfathered Equipment (Rev. 2231, Issued: 05- 27-11, Effective: 08- 28-11, Implementation: 08- 28-11) Non-contract grandfathered suppliers must use the KY modifier on claims for CBA -residing beneficiaries with dates of service on or after January 1, 2011, for purchased, covered accessories or supplies furnished for use with rented grandfathered equipment. The following HCPCS codes are the codes for which use of the KY modifie r is authorized: Continuous Positive Airway Pressure Devices, Respiratory Assistive Devices, and Related Supplies and Accessories - A4604, A7030, A7031, A7032, A7033, A7034, A7035, A7036, A7037, A7038, A7039, A7044, A7045, A7046, E0561, and E0562 Hospita l Beds and Related Accessories - E0271, E0272, E0280, and E0310 Walkers and Related Accessories - E0154, E0156, E0157 and E0158 Grandfathered suppliers that submit claims for the payment of the aforementioned purchased accessories and supplies for use wi th grandfathered equipment should submit the applicable single payment amount for the accessory or supply as their submitted charge on the claim. Non-contract grandfathered suppliers should be aware that purchase claims submitted for these codes without t he KY modifier will be denied. In addition, claims submitted with the KY modifier for HCPCS codes other than those listed above will be denied. After the rental payment cap for the grandfathered equipment is reached, the beneficiary must obtain replacement supplies and accessories from a contract supplier. The supplier of the grandfathered equipment is no longer permitted to furnish the supplies and accessories once the rental payment cap is reached. 50.15 - Hospitals Providing Walkers and Related Acces sories to Their Patients on the Date of Discharge (Rev. 2231, Issued: 05- 27-11, Effective: 08- 28-11, Implementation: 08- 28-11) Hospitals may furnish walkers and related accessories to their own patients for use in the home during an admission or on the da te of discharge and receive payment at the applicable single payment amount, regardless of whether the hospital is a contract supplier or not. Separate payment is not made for walkers furnished by a hospital for use in the hospital, as payment for these it ems is included in the Part A payment for inpatient hospital services. To be paid for walkers as a non- contract supplier, the hospital must use the modifier J4 in combination with the following HCPCS codes: A4636; A4637; E0130; E0135; E0140; E0141; E0143; E0144; E0147; E0148; E0149; E0154; E0155; E0156; E0157; E0158; and E0159. Under this exception, hospitals are advised to submit the claim for the hospital stay before or on the same day that they submit the claim for the walker to ensure timely and accura te claims processing. Hospitals that are located outside a CBA that furnish walkers and/or related accessories to travelling beneficiaries who live in a CBA must affix the J4 modifier to claims submitted for these items. The J4 modifier should not be used by contract suppliers. 50.16 - Exception for Wheelchair Accessories Furnished with Non -Competitively Bid Wheelchair Base Equipment (Rev. 3324, Issued: 08- 14-15, Effective: 07- 01-13, Implementation: 01- 04-16) Effective for c laims with dates of service on or after July 1, 2013, competitively bid wheelchair accessories are paid in accordance with standard Medicare DMEPOS payment rules, not competitive bidding rules, when furnished with non- competitively bid wheelchair base equipment.Transmittals Issued for this Chapter

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Hospitals that are located outside a CBA that furnish walkers and/or related accessories to travelling beneficiaries who live in a CBA must affix the J4 modifier to claims submitted for these items. The J4 modifier should not be used by contract suppliers. 50.16 - Exception for Wheelchair Accessories Furnished with Non -Competitively Bid Wheelchair Base Equipment (Rev. 3324, Issued: 08- 14-15, Effective: 07- 01-13, Implementation: 01- 04-16) Effective for c laims with dates of service on or after July 1, 2013, competitively bid wheelchair accessories are paid in accordance with standard Medicare DMEPOS payment rules, not competitive bidding rules, when furnished with non- competitively bid wheelchair base equipment.Transmittals Issued for this Chapter Rev # Issue Date Subject Impl Date CR# R11427CP 05/20/2022 Claims Processing Manual Update - Pub. 100.04 for Elimination of Certificates of Medical Necessity (CMNs) and Durable Medical Equipment Forms (DIFs) 01/03/2023 12734 R11414CP 05/12/2022 Claims Processing Manual Update - Pub. 100.04 for Elimination of Certificates of Medical Necessity (CMNs) and Durable Medical Equipment Forms (DIFs) - Rescinded and replaced by Transmittal 11427 06/13/2022 12734 R3953CP 01/19/2018 Revisions to the Claims Processing for Grandfathered Oxygen Claims that Span Competitive Bidding Rounds 07/02/2018 10420 R3593CP 08/17/2016 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP): Additional Instructions for the Implementation of Round 2 Recompete of the DMEPOS CBP and National Mail Order (NMO) Recompete 10/03/2016 9579 R3565CP 07/20/2016 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP): Additional Instructions for the Implementation of Round 2 Recompete of the DMEPOS CBP and National Mail Order (NMO) Recompete - Rescinded and replaced by Transmittal 3593 10/03/2016 9579 R3500CP 04/28/2016 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS ) Competitive Bidding Program (CBP): Additional Instructions for the Implementation of Round 2 Recompete of the DMEPOS CBP and National Mail Order (NMO) Recompete - Rescinded and replaced by Transmittal 3565 10/03/2016 9579 R3324CP 08/14/2015 Clarification of the Policy for Competitively -Bid Wheelchair Accessories Furnished with Non-Competitively Bid Wheelchair Base Equipment 01/04/2016 9272 R2979CP 06/27/2014 Update to Pub. 100 -04, Chapter 36 to Provide Language -Only Changes for Updating ASC X12 07/28/2014 8771 R2231CP 05/27/2011 Phase 3 of Manual Revisions to Reflect Payment Changes for Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) 08/28/2011 7401 Rev # Issue Date Subject Impl Date CR# Items as a Result of the DMEPOS Competitive Bidding Program and the Deficit Reduction Act of 2005 R1544CP 06/26/2008 Manual Revisions to R eflect Special Billing Instructions for DMEPOS Items as a Result of the DMEPOS Competitive Bidding Program 07/07/2008 6007 R1532CP 06/11/2008 Phase 2 of Manual Revisions to Reflect Payment Changes for DMEPOS Items as a Result of the DMEPOS Competitive Bidding Program and the Deficit Reduction Act of 2005 07/07/2008 6119 R1502CP 05/09/2008 Initial Release of Chapter -Competitive Bidding 06/09/2008 5978 Back to top of chapter

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Medicare Claims Processing Manual Chapter 37 - Department of Veterans Affairs (VA) Claims Adjudication Services Project Table of Contents (Rev. 11427, 05- 20-22) Transmittals for Chapter 37 1 - Background on the VA Claims Adjudication Services Project 1.1 - Requirements for Processing VA Institutional and Professional Claims 1.1.2 Requirements for Processing VA Durable Medical Equipment Prosthetics Orthotics and Supplies (DMEPOS) Claims 1.2 - Department of VA Claims Adjudication: Coinsurance and Deductible 1.3 - Generating Unsolicited Responses to the VA 1.4 - Use of Legacy Provider Numbers After National Provider Ident ifiers (NPIs ) Are Fully Implemented 1 - Background on the VA Claims Adjudication Services Project (Rev. 1454, Issued: 02- 22-08, Effective: 04 -01-08, Implementation: 04- 07-08) Current law permits the VA to collect appro priate Medicare coinsurance and deductible amounts from supplemental insurers for claims for supplies and services ordinarily covered by Medicare but furnished: At VA facilities; and For veterans eligible to receive both VA health and Medicare benefits and also having Medicare supplemental insurance. To facilitate this process, the Centers for Medicare & Medicaid Services (CMS) entered into an interagency agreement with the VA whereby CMS will help the VA work with the designated CMS MAC to adjudicate cl aims for these services to produce remittance advices equivalent to those ordinarily produced for Medicare claims. Medicare does not pay these claims, but the remittance advices show how much Medicare would have paid had the claims been payable by Medicar e along with the applicable deductibles and coinsurance. In adjudicating a claim and generating these remittance advice notices, the CMS MAC must verify that the services provided are covered benefits, certify admission where appropriate, conduct prepayme nt utilization screening, and authorize payment. CMS has a single A/B MAC (A) and (B) to process these claims. The remittance advices, sent by the VA to the supplemental insurers, will help the insurers determine payment amounts they owe to the VA. The VA funds all of the work on this project, including systems changes. 1.1 - Requirements for Processing VA Institutional and Professional Claims (Rev. 4023, Issued: 04- 20-18, Effective: 07 - 20-18, Implementation: 07- 20- 18) Veterans typically see more than one physician at a VA facility on a given day. The A/B MAC (B) -defined provider number will contain a V in the first position and specialty codes. Including specialty codes permits the VA to have multiple provider numbers to accommodate various pr ofessional services furnished at a given facility on the same day for the same beneficiary -veteran. CWF will edit to ensure that only claims having all three of the following conditions will be processed according to the special VA claims adjudication procedures of this project: 1. A demo number of 31 is present; 2. A V is present in the first position of the A/B MAC (B) defined provider number field (HUBC Field 83 Provider Number, Positions 440- 449); and 3. The VA A/B MAC (B) number is present If only two of these conditions are present, then CWF will reject the claim. If only the demo code of 31 is present, CWF will also reject the claim. The VA will use the ASC X12 837 professional claim format for A/B MAC (B) equivalent claims. To process VA claims from various localities, the VA A/B MAC (A) and (B) has established a database for the Medicare physician fee schedule to include pricing information for all of the States. The VA will use the following bill types for A/B MAC (A) equivalent claims: 11x, (Hospi tal Inpatient, Part A), 12x (Hospital Inpatient, Part B), 13x (Hospital Outpatient), 14x (Hospital Other, Part B), 18x (Hospital Swing Beds), 21x (SNF inpatient), and 23x (SNF outpatient). These claims are submitted using the ASC X12 837 institutional cla im format. The SNF VA provider numbering scheme is as follows: a 2 digit numeric state code, followed by a 5, followed by a 1 digit one up number, followed by with a V, ending with a single position alpha numeric . 1.1.2 Requirements for Processing VA Durable Medical Equipment Prosthetics Orthotics and Supplies (DMEPOS) Claims (Rev. 11427; Issued: 05- 20-22; Effective: 01 -01-23; Implementation: 01- 03-23) NOTE: CMS seeks to reduce burden and modernize processes to ensure a reduction in improper payments and an increase in customer satisfaction. The Certificate of Medical Necessity (CMN) form and DME Information Form (DIF) were originally required to help document the medical necessity and other coverage criteria for selected Durable Medi cal Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) items. In the past, a supplier received a signed CMN from the treating physician or created and signed a DIF to submit with the claim. Due to improvements in claims processing and medical records management, the information found on CMNs or DIFs is available either on the claim or in the medical record and is redundant. Therefore, to reduce burden and increase customer satisfaction, providers and suppliers no longer need to submit these forms for services rendered 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 processes will not change and if the CMN or DIF is required, it will still need to be submitted with the claim, or be on file with a previous claim. This statement applies throughout the Program Integrity Manual wherever CMNs and DIFs are mentioned. The process of receiving VA DMEPOS claims for a no- pay Electronic Medicare Remittance Advice (e- MRA) is effective on April 1, 2018. The processing of these claims, as with the Part A and Part B claims, allows for a CMS no -pay e -MRA to be generated for all DMEPOS claims submitted to CMS by the VA. VA DMEPOS claims are processed by a single DME MAC. For VA DMEPOS claims the e- MRA displays the amount that Medicare would have paid for the claim using the same fee schedule payments as DMEPOS Medicare claims wouldve paid and are based on the beneficiarys state of residence. The same deductible and coinsurance rules applicable to Medicare are applied to the VA claims and are provided on the e -MRA. The VA submits DMEPOS claims via the ANSI X12 837P electronic format. The VA claims will be processed through the Medicare DME MAC Common Electronic Data Interchange (CEDI) front end system, DMEPOS claims processing system (VMS) and the common working file (CWF). In addition to following the ANSI X 12 837P standards for claims submissions the following criteria applies: The VA's submitter of record is the approved biller and submits all VA electronic claims to CEDI. The VA supplies CMS, the VA DME MAC and CEDI with the VA facility NPI list. Validation of the NPI is done at the CMS front end contractor. VA claims are processed as mandatory assigned claims, no beneficiary submitted claims will be processed. VA DMEPOS submitted claims must be for beneficiaries that reside in the US and its territories. The VA must submit claims for Medicare approved HCPCS provided on the DMEPOS jurisdiction list which can be found at https://www.cms.gov/Center/Provider -Type/Durable -Medical -Equipment -DME -Center.html. The VA DMEPOS claims are subject to the Medicare timely filing rules. Claims will be accepted for processing with dates of service one year prior to the date of receipt. The VA will submit paper CMNs for DMEPOS items that require a CMN per Medicare rules. The CMNs will be faxed (until the time VA has the ability to submit CMNs electronically) to the DME MAC. Claims requiring a CMN may be held for up to 2 weeks to allow for receipt of the CMN. Claims will be denied if a CMN is not received within 2 weeks. The CWF edits to ensure the same three conditions stated above for A/B claims are applicable and must be present for adjudication on the DMEPOS claims. In addition, MSP claims are accepted from the VA and the CWF will apply MSP editing to VA DMEPOS claims. Finalized claims will be included in the VA e -MRA an d produced in the CMS flat file format. CEDI will translate the VA e -MRA flat file to the ANSI X12 835 format and make the file(s) available for the VAs submitter of record to retrieve. Adjustments to claims submitted by the VA can be made only for redeterminations or cancels. This applies to all DMEPOS claims submitted by the VA for VA facilities and for independent suppliers. 1.2 - Department of VA Claims Adjudication: Coinsurance and Deductible (Rev. 1454, Issued: 02- 22-08, Effective: 04 -01-08, Implementation: 04 -07-08) Part of this process involves the calculation of the deductible applicable to the Medicare -equivalent VA claims. The CWF calculates the deductible based on true Medicare claims, i.e., for Medicare services rendered by Medicare p roviders to Medicare beneficiaries, and sends this information back to the shared system maintainers for this project. The MCS and FISS further adjust the deductible information received from CWF with the deductible amounts that apply to the Medicare -equivalent VA claims. This arrangement results in a calculation of the deductible for the VA's equivalent of Part A and B claims. In addition, effective January 1, 2005, CWF began to calculate the Part B -equivalent deductible for Medicare claims taking into consideration the VA equivalents of both Medicare outpatient and professional claims as well as true Medicare claims. To confirm that CMS has made no payment on the VA claim, the remittance advice will include message MA118 Coinsurance and or deductible amounts apply to a claim for services or supplies furnished to a Medicare Eligible veteran through a facility of the Department of Veterans Affairs. No Medicare payment issued". Existing claim adjustment reason codes 1 (deductible) and/or 2 (coinsurance) will be used to report those amounts on these remittance advice transactions. As necessary, CWF expands the VA claim auxiliary file within CWF so that the history of VA Part A -equivalent no- pay claims, adjudicated for the MRA Project, contai n sufficient information about the VA claims and Medicare -equivalent Part A deductible and coinsurance amounts applied so that an unsolicited response can be generated. The auxiliary file contains sufficient information so that there can be one such unsol icited response for each VA claim affected. The VA auxiliary file within CWF also provides a claims history for VA Part B equivalent claims. The auxiliary contains the information about VA claims necessary to show Medicare- equivalent Part B deductibles s atisfied by the VA claims. National Claims History is not updated with the VA deductible information, and these changes have no effect on Medicare claims. CWF sends the Part B deductible information to the A/B MACs (A) and (B) for this project. This aff ects claims with dates of service of January 1, 2004, and after and will use deductible amounts for calendar years 2004 and after. 1.3 - Generating Unsolicited Responses to the VA (Rev. 1454, Issued: 02- 22-08, Effective: 04 -01-08, Implementation: 04- 07-08)

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The VA auxiliary file within CWF also provides a claims history for VA Part B equivalent claims. The auxiliary contains the information about VA claims necessary to show Medicare- equivalent Part B deductibles s atisfied by the VA claims. National Claims History is not updated with the VA deductible information, and these changes have no effect on Medicare claims. CWF sends the Part B deductible information to the A/B MACs (A) and (B) for this project. This aff ects claims with dates of service of January 1, 2004, and after and will use deductible amounts for calendar years 2004 and after. 1.3 - Generating Unsolicited Responses to the VA (Rev. 1454, Issued: 02- 22-08, Effective: 04 -01-08, Implementation: 04- 07-08) While the VA is entitled by law to collect the coinsurance and deductible amounts that would have been payable had the claim been a true Medicare claim, it is generally permitted to do so only to the extent that there are no true Medicare claims for coinsurance and deductible submitted to the insurer for the same beneficiary for the same year. While the VA submits these Medicare -equivalent claims in good faith, based on the current deductible information within CWF and maintained by the shared systems, situations sometimes arise where a true Medicare claim is subsequently adjudicated and for whom the insurers' payment of deductible is owed. When this occurs, and the supplemental insurer processes the true Medicare claim, it may deny the claim believing it has already paid the deductible, with the possible result of providers in turn billing the Medicare beneficiary for this amount. While the VA is willing to pay back the amounts it collected in error, it will not always know that this situation has occu rred, and has asked Medicare to help it determine when this situation has transpired. The solution is an unsolicited response, sent to the VA, indicating that a change in Medicare deductible has occurred since the adjudication of the VA claim. The unsoli cited response will show the amount of deductible approved for the affected VA claim and the total true Medicare deductible satisfied as of the date the Medicare claim was adjudicated. There will be one unsolicited response per affected VA claim. The unsolicited responses will be generated each time a Medicare claim affecting the deductible is adjudicated after the adjudication of a VA claim applying a deductible for the same year of service, even if the VA claim has not overapplied the deductible. Although this provision became effective January 1, 2006, it affects claims with dates of service January 1, 2004, and later. 1.4 - Use of CMS Certification Numbers (CCNs) After National Provider Identifiers (NPIs) Are Fully Implemented (Rev. 11396, Issued:05- 04-2022, Effective:10 -01-2022, Implementation:10- 03-2022) While equivalent to Medicare claims in overall appearance and the nature of the services rendered, VA claims contain unique elements to ensure that they are processed appropriately and apart from Me dicare claims, and in particular that payment is not made. Among these characteristics are a demo code and provider numbers which are unique to this project. CMS has determined that it is in its best interests to have the VA continue to submit the MRA project transactions with its CMS Certification Number (CCN) instead of NPIs. In addition, if the VA providers begin using an NPI for other purposes, Medicare -equivalent remittance advice claims must be submitted to CMS with a VA CMS Certification Number (CCN) as the provider identifier. The demo number (31) will be assigned based on the CCN submitted and by the A/B MAC (A) or (B) number. Transmittals Issued for this Chapter Rev # Issue Date Subject Impl Date CR# R11427CP 05/20/2022 Claims Processing Man ual Update - Pub. 100.04 for Elimination of Certificates of Medical Necessity (CMNs) and Durable Medical Equipment Forms (DIFs) 01/03/2023 12734 R11414CP 05/12/2022 Claims Processing Manual Update - Pub. 100.04 for Elimination of Certificates of Medical Necessity (CMNs) and Durable Medical Equipment Forms (DIFs) Rescinded and replaced by Transmittal 11427 06/13/2022 12734 R11396CP 05/04/2022 Update to Chapters 3, 4, 27 and 37 of Publication (Pub.) 100- 04 Medicare Claims Processing Manual to Remove Reference to the Term "OSCAR" 10/03/2022 12715 R4023CP 04/20/2018 Update of Internet Only Manual (IOM), Medicare Claims Processing Manual, Publication 100- 04, Chapter 37 - Department of Veterans Affairs (VA) Claims Adjudication Services Project 07/20/2018 10621 R3009CP 08/01/2014 Update to Pub. 100 -04, Chapter 37 to Provide Language -Only Changes for Updating ASC X12 09/02/2014 8770 R1454CP 02/22/2008 Department of Veterans Affairs (VA) Claims Adjudication Services Project - New IOM Chapter - Pub. 100- 04, Chapter 37 Department of Veterans Affairs (VA) Claims Adjudication Services Project 04/07/2008 5938 Back to top of chapter

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Medicare Claims Processing Manual Chapter 38 - Emergency Preparedness Fee- For-Service Guidance Table of Contents (Rev. 10135, 05- 15-20) Transmittals for Chapter 38 01 Foreward 10 Use of the CR Modifier and DR Condition Code for Disaster/Emergency -Related Claims 01 Foreward (Rev. 1784, Issued: 07- 31-09, Effective: 08- 31-09, Implementation: 08 -31-09) Generally, this chapter describes the guidance that may be implemented for the Medicare fee-for-service program in the event of a disaster/emergency. As part of its preparedness efforts for a disaster/emergency, the Centers for M edicare and Medicaid Services (CMS) has developed certain disaster/emergency guidance that may be implemented for the Medicare fee- for-service program in the event of a disaster/emergency. CMS has also developed certain additional disaster/emergency guida nce that may be implemented if: 1. the President declares an emergency or disaster under the National Emergencies Act or the Stafford Act; and 2. the Secretary of the Department of Health and Human Services declares - under 319 of the Public Health Servi ce Act - that a public health emergency exists, and 3. the Secretary elects to waive one or more requirements of Title XVIII of the Social Security Act (Act) pursuant to 1135 of such Act. Until CMS declares these guidances to be in effect, the guidances are considered to be pending. 10 Use of the CR Modifier and DR Condition Code for Disaster/Emergency -Related Claims (Rev. 2999, Issued; 07- 25-14, Effective: 01- 01-12, Implementation: 08- 25-14) In order to facilitate claims processing and track services and items provided to beneficiaries during disaster/emergency situations, a modifier and condition code have been established for providers to use on disaster/emergency related claims. The modifier and condition code have been in effect since August 21, 2005. The codes are effective for dates of service on and after August 21, 2005. The modifier and/or condition code can be used by providers submitting claims for beneficiaries who are emergency patients in any part of the country. The DR Condition Code : The title of the DR condition code is disaster related and its definition requires it to be used to identify claims that are or may be impacted by specific payer/health plan policies related to a national or regional disaster. The DR condition code is used only for institutional billing, i.e., claims submitted by providers using the ASC X12 837 institutional claim format or on an institutional paper claim Form CMS -1450. In previous emergencies, use of the DR condition code ha s been discretionary with the billing provider or supplier. It no longer may be used at the provider or suppliers discretion. Use of the DR condition code will be mandatory for any claim for which Medicare payment is conditioned on the presence of a form al waiver, as defined below. The DR condition code also may be required for any type of claim for which, at the A/B MAC (A)s or (HHH) s discretion or as directed by CMS in a particular disaster or emergency, the use of the DR condition code is needed to efficiently and effectively process claims or to otherwise administer the Medicare fee- for-service program. The CR Modifier : Both the short and long descriptors of the CR modifier are catastrophe/disaster related . The CR modifier is used in relation t o Part B items and services for both institutional and non- institutional billing. Non -institutional billing, i.e., claims submitted by physicians and other suppliers, are submitted either using the ASC X12 837 professional claim format or on a professional paper claim Form CMS -1500 or, for pharmacies, in the NCPDP format. In previous emergencies, use of the CR modifier has been discretionary with the billing provider or supplier. It no longer may be used at the provider or suppliers discretion. Use of the CR modifier will be mandatory for applicable HCPCS codes on any claim for which Medicare Part B payment is conditioned on the presence of a formal waiver, as defined below. The CR modifier also may be required for any HCPCS code for which, at the A/B MAC (A)s, (B) s, or (HHH)s or DME MACs discretion or as directed by CMS in a particular disaster or emergency, the use of the CR modifier is needed to efficiently and effectively process claims or to otherwise administer the Medicare fee- for-service program. Formal Waivers : A formal waiver is a waiver of a program requirement that otherwise would apply by statute or regulation. There are two types of formal waivers. One type is a temporary waiver or modification of a requirement under the autho rity described in 1135 of the Social Security Act (the Act). Although Medicare payment rules themselves are not waivable under this statutory provision, the waiver authority under 1135 may permit Medicare payment in a circumstance where such payment would otherwise be barred because of noncompliance with the requirement being waived or modified. The second type of formal waiver is a waiver based on a provision of Title XVIII of the Act or its implementing regulations. The most commonly employed waiver in this latter category is the waiver of the 3 -day qualifying hospital stay requirement that is a precondition for Medicare payment for skilled nursing facility services. This requirement may be waived under 1812(f) of the Act . Several conditions must be met for a 1135 waiver to be implemented. First, the President must declare an emergency or disaster under the National Emergencies Act or the Robert T. Stafford Disaster Relief and Emergency Assistance Act. Such a declaration will specify both an ef fective date and the geographic area(s) covered by the declaration. Second, the Secretary of the Department of Health and Human Services must declare - under 319 of the Public Health Service Act - that a public health emergency exists within some or all of the areas covered by the Presidential declaration. Third, the Secretary must authorize the waiver of one or more requirements specified in 1135 of the Act. Fourth, the Secretary or the Administrator of CMS must determine which Medicare program requir ements, if any, may be waived or modified under the Secretarys authorization and whether specific conditions within the geographic area(s) specified by the Secretarys declaration warrant waiver or modification of one or more requirements of Title XVIII o f the Act. If all of the foregoing conditions are met, the Secretary or CMS Administrator may specify the extent to which a waiver or modification of a specific Medicare requirement is to be applied within the geographic area(s) with respect to which the waiver authority has been invoked. The waiver of a Medicare requirement based on authority included in the provision of Title XVIII of the Act or its implementing regulations may be made at the discretion of the Administrator of CMS unless otherwise speci fied. Such a waiver does not require either a Presidential or a Secretarial declaration nor, if such declarations are made, would such a waiver be necessarily limited by the geographic boundaries specified in such declarations. Nevertheless, the Administ rator may elect to limit the effect of Title XVIII waivers to such geographic areas and to such time frames as are specified by such declarations. A Medicare requirement established in statute or regulation that is not subject to waiver under either of these types of formal waiver generally may not be waived as a matter of administrative discretion. Because most Medicare requirements are not waivable, nearly all Medicare entitlement, coverage, and payment rules will remain in effect during a disaster or emergency. Informal Waivers : An informal waiver is a discretionary waiver or relaxation of a procedural norm, when such norm is not required by statute or regulation, but rather is reflected in CMS guidance or policy. Such norm may be waived or r elaxed administratively if circumstances warrant. One example of such a norm would be claims filing jurisdiction. In the event of a disaster/emergency that impaired or limited operations at a particular Medicare Administrative Contractor (MAC), alternative claims filing jurisdictions could be established. Informal waivers are made by the CMS Administrator or his/her delegates. Further Instructions in the Event of a Disaster or Emergency : In the event of a disaster or emergency, CMS will issue specific guidance to MACs via one or more Technical Direction Letter (TDL) that will contain a summary of the Secretarys declaration (if any); specify the geographic areas affected by any declarations of a disaster or emergency; specify what formal waivers and/or informal waivers, if any, have been authorized; specify the beginning and end dates that apply to the use of the DR condition code and/or the CR modifier; and specify what other uses of the condition code and/or modifier, if any, will be mandatory for the particular disaster/emergency. Reporting Utilization of the Condition Code and Modifier : MACs must compile reports of utilization of the use of the condition code and/or modifier as specified via any TDL as may be issued in the event of a specific disast er or emergency. B. Policy: The DR Condition Code : The DR condition code is used for institutional billing only. Use of the DR condition code is required when a service is affected by an emergency or disaster and Medicare payment for such service is conditioned on the presence of a formal waiver (as that term is described in Background, above) Use of the DR condition code also may be required when either the A/B MAC (A) or (HHH) or CMS determine that such use is needed to efficiently and effectively process claims or to otherwise administer the Medicare fee -for-service program. The DR condition code is used at t he claim level when all of the services/items billed on the claim are related to the emergency/disaster. The CR Modifier : The CR modifier is used for Part B items and services only but may be used in either institutional or non -institutional billing. Use of the CR modifier is required when an item or service is impacted by an emergency or disaster and Medicare payment for such item or service is conditioned on the presence of a formal waiver (as that term is described in Background, above) Use of th e CR modifier also may be required when either the A/B MAC (A), (B), or (HHH), or DME MAC or CMS determine that such use is needed to efficiently and effectively process claims or to otherwise administer the Medicare fee -for-service program. Transmittals Issued for this Chapter Rev # Issue Date Subject Impl Date CR# R10135CP 05/15/2020 Manual Update to Pub. 100 -04, Chapter 38, to Remove Identification of Items or Services Related to the 2010 Oil Spill in the Gulf of Mexico Section 06/16/2020 11778 R2999CP 07/25/2014 Update to Pub. 100 -04, Chapter 38 to Provide Language -Only Changes for Updating ASC X12 08/25/2014 8772 R2021CP 08/06/2010 National Modifier and Condition Code to Identify Items or Services Related to the 2010 Oil Spill in the Gulf of Mexico 01/03/2011 7087 R1784CP 07/31/2009 The Use of the CR Modifier and DR Condition Code on Disaster/Emergency Related Claims -Initial re lease of chapter 08/31/2009 6451 Back to top of chapter

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Medicare Claims Processing Manual Chapter 39 Opioid Treatment Programs (OTPs) Table of Contents (Rev. 12418; Issued: 12- 21-23) Transmittals for Chapter 39 10 - General 20 - Statutory authority for OTPs billing Medicare 30 - Bundled payments for Opioid Use Disorder (OUD) treatment services 30.1 - Duration of bundle 30.2 - Requirements for an Episode 30.3 - Non -drug episode of care 30.4 - New drugs 30.5 - Site of service (telecommunications) 30.6 - Coding 30.6.1 - Adjustments to Bundled Payment Rate 30.7 - Cost Sharing 30.8 - Locality Adjustments 30.9 - Annual Updates 40 - Practitioner Claims submission A/B MAC (B) 40.1 - Place of Service 40.2 - Date of Service 40.3 - Prescribing Individuals 50 Institutional Opioid Treatment Program (OTP) Services A/B MAC (A) 50.1 Special Opioid Treatment Program Billing Requirements for Hospitals, Critical Access Hospitals, and Free -Standing Opioid Treatment Program Facilities 10 - General (Rev. 4524: Issued; 02- 14-20: Effective; 01 -01-20: Implementation: 03 -16-20) This chapter provides claims processing instructions for Opioid Treatment Programs (OTPs). The Medicare Benefit Policy Manual, Chapter 17, provides coverage policy for OTPs. 20 - Statutory authority for OTPs billing Medicare (Rev. 4524: Issued; 02- 14-20: Effective; 01 -01-20: Implementation: 03 -16-20) Section 2005 of the SUPPORT Act amended section 1861 of the Act by adding a new subsection (jjj)(2) to define an OTP as an entity meeting the definition of OTP in 42 CFR 8.2 or any successor regulation (that is, a program or practitioner engaged in opioid treatment of individuals with an opioid agonist treatment medication registered under 21 U.S.C. 823(g)(1)), that meets the additional requirements set forth in subparagraphs (A) through (D) of section 1861(jjj)(2) of the Act. Specifically that the OTP: is enrolled under section 1866(j) of the Act; has in effect a certification by the Substance Abuse and Mental Health Services Administration (SAMHSA) for such a program; is accredited by an accrediting body approved by SAMHSA; and meets such additional condi tions as the Secretary may find necessary to ensure the health and safety of individuals being furnished services under such program and the effective and efficient furnishing of such services. We defined opioid treatment program at 410.67(b) as an entity that is an OTP as defined in 8.2 (or any successor regulation) that meets the applicable requirements for an OTP. For an OTP to participate and receive payment under the Medicare program, the OTP must be enrolled under section 1866(j) of the Act, have in effect a certification by SAMHSA for such a program, and be accredited by an accrediting body approved by SAMHSA. 30 - Bundled payments for Opioid Use Disorder (OUD) treatment services (Rev. 4524: Issued; 02- 14-20: Effective; 01 -01-20: Implementation: 03 -16-20) The bundled payment rates are calculated by combining the drug component and the non- drug components. 30.1 - Duration of bundle (Rev. 4524: Issued; 02- 14-20: Effective; 01 -01-20: Implementation: 03 -16-20) An episode of care is defined at 410.67(b) as a 1 -week (contiguous 7- day) period. There is no maximum number of weeks for a course of treatment for OUD. 30.2 - Requirements for an Episode (Rev. 12418; Issued: 12- 21-23; Effective: 01 -01-24; Implementation: 01- 24-24) In recognition that there is a range of service intensity depending on the severity of a patients OUD and stage of treatment, a full weekly bundle may consist of a very different frequency of services for a patient in the initial phase of treatment compared to a patient in the maintenance phase of treatment, or based on other factors such as pregnancy or relapse. The threshold to bill the weekly episode is the delivery of at least one service in the weekly bundle (from either the drug or non- drug component) to the patient during the week that corresponds to the episode of care. If no drug was provided to the patient during that episode, the OTP must bill the G-code describing the weekly bundle not including the drug (HCPCS code G 2074) and the threshold to bill would be at least one service in the non- drug component. If a drug was provided with or without additional non- drug component services, the appropriate G-code describing the weekly bundle that includes the drug furnished may be billed. For OTP intensive outpatient services, the threshold to bill HCPCS code G0137 for these services is a minimum of nine services furnished over a 7 -continguous day period. These services are described in 410.67(b)(ix) in the definition of OTP intensive outpatient services. A minimum of nine OTP intensive outpatient services, regardless of the length or time duration of these services, meets the threshold to bill, including if services of the same type are furnished more than once a week as long as all ser vices are medically reasonable and necessary for the treatment of OUD. However, an OTP may not count an intensive outpatient program service for the purposes of the nine -service threshold if that same service is being used to qualify for billing other week ly bundles and add- on codes under the OTP benefit. Additionally, to bill HCPCS code G0137, a physician or non-physician practitioner (as defined in section 1842(b)(18)(C) of the Act) must certify that the individual has a need for a minimum of nine hours of services per week and requires a higher level of care intensity compared to other non- intensive outpatient OTP services. A physician or non-physician practitioner, as permitted by state law and scope of practice requirements, must also meet requirements for certification, plan of treatment, and recertification requirements as set forth in 424.24(d)(1) through (3) for the purposes of furnishing OTP intensive outpatient services. 30.3 - Non-drug episode of care (Rev. 4524: Issued; 02- 14-20: Effective; 01 -01-20: Implementation: 03 -16-20) HCPCS code G2074 describes a non- drug episode of care. This provides a mechanism for OTPs to bill for non-drug services, including substance use counseling, individual and group therapy, and toxicology testing, that are rendered during weeks when a medicat ion is not administered, for example, in cases where a patient is being treated with injectable buprenorphine or naltrexone on a monthly basis or has a buprenorphine implant. 30.4 - New drugs (Rev. 4524: Issued; 02- 14-20: Effective; 01 -01-20: Implementation: 03 -16-20) We anticipate that there may be new Food and Drug Administration (FDA) -approved opioid agonist and antagonist treatment medications to treat OUD in the future. OTPs may bill for an episode of care using the medication not otherwise specified (NOS) code (HCPCS code G2075) in the scenario where an OTP furnishes MAT using a new FDA -approved opioid agonist or antagonist medication for OUD treatment that is not specif ied in one of our existing codes. In such cases, the typical or average maintenance dose would be used to determine the drug cost for the new bundle, which contractors would then add to the non- drug component payment amount that corresponds with the releva nt payment for drug administration (oral, injectable, or implantable) to determine the total bundled payment for the episode of care. Pricing for the drug component should be determined based on the relevant pricing methodology as described in the CY 2020 Physician Fee Schedule final rule or through invoice pricing in the event the information necessary to apply the relevant pricing methodology is not available. 30.5 - Site of service (telecommunications) (Rev. 12418; Issued: 12- 21-23; Effective: 01 -01-24; Implementation: 01- 24-24) OTPs can use two -way interactive audio -video communication technology, as clinically appropriate, to furnish the substance use counseling and individual and group therapy services included in the bundled payment, as well as the add -on code for additional counseling and therapy. During the Public Health Emergency (PHE) for the COVID -19 pandemic, and following the end to the PHE on May 11th, 2023, the therapy and counseling portions of the weekly bundles of services furnished by OTPs, additional counseling or therapy payable under the add-on code for additional counseling or therapy, and the OTP intake add-on code for the initiation of treatment with buprenorphine (but not methadone), may be furnished using audio -only telephone calls rather than via two- way interactive audio-video communication technology if beneficiaries do not have access to two -way audio/video communications technology, provided all other applicable requirements are met. This includes instances when the beneficiary is not capable of, or does not consent to, the use video technology for the service. Beginning January 1, 2021, periodic assessments may be furnished via two-way interactive audio-video communication technology, as clinically appropriate, and in compliance with all applicable requirements, and in cases where a beneficiary does not have access to two-way audio-video communications technology, periodic assessments can be furnished using audio -only telephone calls during the PHE and through the end of CY 2024 if all other applicable requirements are met. OTPs providing intensive outpatient services to Medicare beneficiaries with an OUD shall not receive payment under Medicare part B if these services are furnished via audio- video or audio-only communications technology. After the conclusion of the PHE for the COVID -19 pandemic , which ended on May 11, 2023, CMS expects OTPs to add Modifier 93 (Synchronous telemedicine service rendered via telephone or other real-time interactive audio -only telecommunications system) to the claim for counseling and therapy provided via audio- only telecommunications using HCPCS code G2080, as well as for intake activities and periodic assessments furnished using audio- only communication technology. Additionally, CMS expects OTPs to add Modifier 95 (Synchronous Telemedicine Service Rendered via Real-Time Interactive Audio and Video Telecommunications System) to the claim for counseling and therapy provided via audio- video telecommunications using HCPCS code G2080, as well as for intake activities and periodic assessments furnished using audio and video communication technology. As OTP services are not PFS services, no originating site facility fee (HCPCS code Q3014) applies to OUD treatment services, and OTPs are not authorized to bill for the originating site facility fee. Additionally, the payment for the substance use counseling and individual and group therapy are included in the bundled payment rates made to OTPs; therefore, the practitioner furnishing the service remotely should not bill separately for the service. 30.6 Coding (Rev. 12418; Issued: 12- 21-23; Effective: 01 -01-24; Implementation: 01- 24-24) The codes describing bundled payments made to OTPs are HCPCS codes G2067- G2075. There are add- on codes described by HCPCS codes G2076- G2080, HCPCS codes G2215, G2216, G1028, and G0137 . Only an entity enrolled with Medicare as an OTP can bill these codes. Additionally, OTPs are limited to billing only these codes describing bundled payments, and may not bill for other codes, such as those paid under the PFS. The coding structure for OUD treatment services varies by the medication administered. There are G codes for weekly bundles describing treatment with methadone, oral buprenorphine, injectable buprenorphine, buprenorphine implants (insertion, removal, and i nsertion/removal), extended- release injectable naltrexone, a non- drug bundle, and one for a medication not otherwise specified (see full list of codes below).

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30.6 Coding (Rev. 12418; Issued: 12- 21-23; Effective: 01 -01-24; Implementation: 01- 24-24) The codes describing bundled payments made to OTPs are HCPCS codes G2067- G2075. There are add- on codes described by HCPCS codes G2076- G2080, HCPCS codes G2215, G2216, G1028, and G0137 . Only an entity enrolled with Medicare as an OTP can bill these codes. Additionally, OTPs are limited to billing only these codes describing bundled payments, and may not bill for other codes, such as those paid under the PFS. The coding structure for OUD treatment services varies by the medication administered. There are G codes for weekly bundles describing treatment with methadone, oral buprenorphine, injectable buprenorphine, buprenorphine implants (insertion, removal, and i nsertion/removal), extended- release injectable naltrexone, a non- drug bundle, and one for a medication not otherwise specified (see full list of codes below). The code describing the bundled payment for an episode of care with a medication not otherwise specified (HCPCS code G2075) should be used when the OTP furnishes MAT with a new opioid agonist or antagonist treatment medication approved by the FDA under sec tion 505 of the FFDCA for the treatment of OUD. OTPs may use this code until CMS has the opportunity to propose and finalize a new G code to describe the bundled payment for treatment using that drug and price it accordingly in the next rulemaking cycle. HCPCS code G2075 should not be used when the drug being administered is not a new opioid agonist or antagonist treatment medication approved by the FDA under section 505 of the FFDCA for the treatment of OUD, and therefore, for which Medicare would not have the authority to make payment since section 1861(jjj)(1)(A) of the Act requires that the medication must be an opioid agonist or antagonist treatment medication approved by the FDA under section 505 of the FFDCA for the treatment of OUD. HCPCS code G2074, which describes a non- drug bundle, can be billed for services furnished during an episode of care when a medication is not administered, but other services in the bundle are furnished. For example, when a patient receives a buprenorphine injection on a monthly basis, the OTP will only require payment for the medication during the first week of the month when the injection is given, and therefore, would bill the code describing the bundle that includes injectable buprenorphine during the first week of the month and would bill the code describing the non- drug bundle for the remaining weeks in that month for services such as substance use counseling, individual and group therapy, and toxicology testing. NOTE: Some of the bundled payment codes describe a drug that is typically only administered once per month, such as the injectable drugs, or once in a 6 -month period, in the case of the buprenorphine implants. In those cases, the code describing the bundled payment that includes the cost of the drug would be billed during the week that the drug is administered, and if at least one service is furnished in a subsequent week, the non- drug bundle would be billed. For example, in the case of a patient receiving injectable buprenorphine, CMS would expect that HCPCS code G2069 would be billed for the week during which the injection was administered and that HCPCS code G2074, which describes a bundle not including the drug, would be bil led during any subsequent weeks that at least one non- drug service is furnished until the injection is administered again, at which time HCPCS code G2069 would be billed again for that week. CMS notes that as HCPCS codes G2067 G2075, and G0137, cover episodes of care of 7 contiguous days, CMS will not permit an OTP to bill any of these codes for the same beneficiary more than once per 7 contiguous day period. Additionally, consistent with FDA labelling, CMS does not generally expect the codes d escribing bundled payments including the injectable drugs (HCPCS codes G2069 and G2073) to be furnished more than once every 4 weeks. Similarly, consistent with FDA labelling, CMS does not generally expect the codes describing bundled payments including insertion of the buprenorphine implants (HCPCS codes G2070 and G2072) to be furnished more than once every 6 months. CMS understands there are limited clinical scenarios when a beneficiary may be appropriately furnished OUD treatment services at more than one OTP within a 7 contiguous day period, such as for guest dosing or when a beneficiary transfers care between OTPs. In these limited circumstances, each of the involved OTPs may bill the appropriate HCPCS codes that reflect the services furnished to the beneficiary. CMS expects that both OTPs involved would provide sufficient documentation in the patients medical record to reflect the clinical situation and services provided. Additionally, in instances in which a patient is switching from one drug to another, the OTP should only bill for one code describing a weekly bundled payment for that week and should determine which code to bill based on which drug was furnished for the majority of the week. 30.6.1 - Adjustments to Bundled Payment Rate (Rev. 12418; Issued: 12- 21-23; Effective: 01 -01-24; Implementation: 01- 24-24) There are add -on codes for intake activities, periodic assessments, take- home supplies of methadone, take home supplies of oral buprenorphine, additional counseling or therapy services furnished, and for take-home supplies of naloxone. CMS notes that the add-on code describing intake activities (HCPCS code G2076) should only be billed for new patients (that is, patients starting treatment at the OTP). There are two add -on codes that describe take- home doses of medication, one for take -home supplies of methadone (HCPCS code G2078), which describes up to 7 additional days of medication, and can be billed along with the respective weekly bundled payment in units of up to 3 (for a total of up to a one month supply), and one for take -home supplies of oral buprenorphine (HCPCS code G2079), which also describes up to 7 additional days of medication and can be billed along with the base bundle in units of up to 3 (for a total of up to a 1 month supply). SAMHSA allows a maximum take -home supply of one month of medication; therefore, CMS does not expect the add-on codes describing take- home doses of methadone and oral buprenorphine to be billed any more than 3 times in one month (in addition to the weekly bundled payment). The add- on code for take -home doses of methadone can only be used with the methadone weekly episode of care code (HCPCS code G2067). Similarly, the add- on code for take -home doses of oral buprenorphine can only be used with the oral buprenorphine weekly episode of care code (HCPCS code G2068). HCPCS code G2080 may be billed when counseling or therapy services are furnished that substantially exceed the amount specified in the patients individualized treatment plan. OTPs are required to document the medical necessity for these services in the patients medical record. OTPs billing for intensive outpatient services (G0137) must be furnishing these services as part of a distinct and organized intensive ambulatory treatment program for the treatment of Opioid Use Disorder, and as part of a program that offers less than 24- hour daily care other than in an individual's home or in an inpatient or residential setting. By billing G0137, OTPs are attesting that these intensive outpatient services are reasonable and necessary for the diagnosis or active treatment of the individual 's condition; are reasonably expected to improve or maintain the individual's condition and functional level and to prevent relapse or hospitalization; and are furnished in accordance with a physician or non- physician practitioner (as defined in section 1842(b)(18)(C) of the Act) certification and plan of care, as permitted by State law and scope of practice requirements. A physician or non- physician practitioner must certify that the individual has a need for a minimum of nine hours of services per week and requires a higher level of care intensity compared to other non- intensive outpatient OTP services. FDA -approved opioid agonist or antagonist medications for the treatment of OUD, opioid antagonist medications for the emergency treatment of known or suspe cted opioid overdose, or toxicology testing, do not count as payable OTP intensive outpatient services but if rendered, should be billed using existing bundles and/or add-on codes as long as all other applicable requirements are met. The codes and long descriptors for the OTP bundled services and add-on services are: HCPCS code G2067: Medication assisted treatment, methadone; weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing, if performed (provision of the services by a Medicare -enrolled Opioid Treatment Program). HCPCS code G2068: Medication assisted treatment, buprenorphine (oral); weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a Medicare -enrolled Opioid Treatment Program). HCPCS code G2069: Medication assisted treatment, buprenorphine (injectable); weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a Medicare -enrolled Opioid Treatment Program). HCPCS code G2070: Medication assisted treatment, buprenorphine (implant insertion); weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a Medicare -enrolled Opioid Treatment Program). HCPCS code G2071: Medication assisted treatment, buprenorphine (implant removal); weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a Medicare -enrolled Opioid Treatment Program). HCPCS code G2072: Medication assisted treatment, buprenorphine (implant insertion and removal); weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a Medicare -enrolled Opioid Treatment Program). HCPCS code G2073: Medication assisted treatment, naltrexone; weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a Medicare -enrolled Opioid Treatment Program). HCPCS code G2074: Medication assisted treatment, weekly bundle not including the drug, including substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a Medicare- enrolled Opioid Treatment Program). HCPCS code G2075: Medication assisted treatment, medication not otherwise specified; weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing, if performed (provision of the services by a Medicare -enrolled Opioid Treatment Program). HCPCS code G0137: Intensive outpatient services; minimum of nine services over a 7 - contiguous day period, which can include individual and group therapy with physicians or psychologists (or other mental health professionals to the extent authorized under State law); occupational therapy requiring the skills of a qualified occupational therapist; services of social workers, trained psychiatric nurses, and other staff trained to work with psychiatric patients; drugs and biologicals furnished for therapeutic purposes, excluding opioid agonist and antagonist medications that are FDA -approved for use in treatment of OUD or opioid antagonist medications for the emergency treatment of known or suspected opioid overdose; individualized activity therapies that are not primarily recreational or diversionary; family counseling (the primary purpose of which is treatment of the individuals condition); patient training and education (to the extent that training and educational activities are closely and clearly related to individuals care and treatment); diagnostic services (not including toxicology testing); (provision of the services by a Medicare -enrolled Opioid Treatment Program); List separately in addition to code for primary procedure, if applicable

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HCPCS code G0137: Intensive outpatient services; minimum of nine services over a 7 - contiguous day period, which can include individual and group therapy with physicians or psychologists (or other mental health professionals to the extent authorized under State law); occupational therapy requiring the skills of a qualified occupational therapist; services of social workers, trained psychiatric nurses, and other staff trained to work with psychiatric patients; drugs and biologicals furnished for therapeutic purposes, excluding opioid agonist and antagonist medications that are FDA -approved for use in treatment of OUD or opioid antagonist medications for the emergency treatment of known or suspected opioid overdose; individualized activity therapies that are not primarily recreational or diversionary; family counseling (the primary purpose of which is treatment of the individuals condition); patient training and education (to the extent that training and educational activities are closely and clearly related to individuals care and treatment); diagnostic services (not including toxicology testing); (provision of the services by a Medicare -enrolled Opioid Treatment Program); List separately in addition to code for primary procedure, if applicable HCPCS code G2076: Intake activities, including initial medical examination that is a complete, fully documented physical evaluation and initial assessment conducted by a program physician or a primary care physician, or an authorized healthcare professional under the supervision of a program physician or qualified personnel that includes preparation of a treatment plan that includes the patients short -term goals and the tasks the patient must perform to complete the short -term goals; the patients requirem ents for education, vocational rehabilitation, and employment; and the medical, psycho- social, economic, legal, or other supportive services that a patient needs, conducted by qualified personnel (provision of the services by a Medicare -enrolled Opioid Tr eatment Program); List separately in addition to code for primary procedure. HCPCS code G2077: Periodic assessment; assessing periodically by qualified personnel to determine the most appropriate combination of services and treatment (provision of the services by a Medicare -enrolled Opioid Treatment Program); List separately in addition to code for primary procedure. HCPCS code G2078: Take -home supply of methadone; up to 7 additional day supply (provision of the services by a Medicare- enrolled Opioid Treatment Program); List separately in addition to code for primary procedure. HCPCS code G2079: Take- home supply of buprenorphine (oral); up to 7 additional day supply (provision of the services by a Medicare -enrolled Opioid Treatment Program); List separately in addition to code for primary procedure. HCPCS code G2080: Each additional 30 minutes of counseling or group or individual therapy in a week of medication assisted treatment, (provision of the services by a Medicare -enrolled Opioid Treatment Program); List separately in addition to code for primary procedure. HCPCS code G2215: Take -home supply of nasal naloxone; 2- pack of 4mg per 0.1 mL nasal spray (provision of the services by a Medicare- enrolled Opioid Treatment Program); List separately in addition to code for primary procedure. HCPCS code G2216: Take- home supply of injectable naloxone (provision of the services by a Medicare- enrolled Opioid Treatment Program); List separately in addition to code for primary procedure. HCPCS code G1028: Take -home supply of nasal naloxone; 2- pack of 8mg per 0.1 mL nasal spray (provision of the services by a Medicare- enrolled Opioid Treatment Program); List separately in addition to code for primary procedure. 30.7 - Cost Sharing (Rev. 10665: Issued; 03- 16-21: Effective; 01 -01-21: Implementation: 04 -15-21) There is zero beneficiary copayment for the codes billed by OTPs. However, the Part B deductible does apply, as mandated for all Part B services by section 1833(b) of the Act. 30.8 - Locality Adjustments (Rev. 12418; Issued: 12- 21-23; Effective: 01 -01-24; Implementation: 01- 24-24) The payment amounts for the non- drug component of the bundled payment for an episode of care, and the adjustments for counseling or therapy, intake activities, periodic assessments, take -home supplies of naloxone, and intensive outpatient program services (HCPCS codes G2067- G2077, G2080, G2215, G2216, G1028, and G0137) will be geographically adjusted using the Geographic Adjustment Factor (GAF). Additionally, for purposes of the GAF, OUD treatment services that are furnished via an OTP mobile unit will be treated as if they were furnished at the physical location of the OTP registered with the Drug Enforcement Administration (DEA) and certified by SAMHSA. 30.9 - Annual Updates The payment amounts for the non-drug component of the bundled payment for an episode of care, and the adjustments for counseling or therapy, intake activities, periodic assessments, and intensive outpatient program services (HCPCS codes G2067- G2077, G2080, and G0137) will be updated annually using the Medicare Economic Index. 40 - Practitioner Claims submission A/B MAC (B) (Rev. 12418; Issued: 12- 21-23; Effective: 01 -01-24; Implementation: 01- 24-24) Beginning January 1, 2020, claims for OTP services are submitted using the 837P transaction to transmit health care claims electronically, or using the CMS -1500 (the paper version of the 837P). Beginning January 1, 2021, OTPs may apply on the Medicare Enrollment Application for Institutional Providers (CMS -855A) or through the Internet -based Provider Enrollment, Chain and Ownership System (PECOS)(837I) when they enroll in the Medicare Program. These providers will submit claims using the CMS -1450. HCPCS codes G2067- G2075, and G0137, cover episodes of care of 7 continuous days and cannot be billed for the same patient more than once per 7 continuous day period. HCPCS codes G2076- G2080 are add-on codes that are billed in addition to one of the base bundle codes (Rev. 12418; Issued: 12 -21-23; Effective: 01 -01-24; Implementation: 01 -24-24) described by HCPCS codes G2067- G2075. Consistent with FDA labeling, HCPCS codes G2069 and G2073 should not be used more than once every 4 weeks and HCPCS codes G2070 and G2072 should not be used more than once every 6 months. HCPCS codes G2078 and G2079 may be billed in multiple units, up to 3 in one month (in addition to the base bundle code). HCPCS codes G2215 and G2216 are limited to being billed once every 30 days, however, exceptions to this limit are allowed in the case where the beneficiary overdoses and uses the initial supply of naloxone dispensed by the OTP to the extent that it is medically reasonable and necessary to furnish additional naloxone. If an additional supply of naloxone is needed within 30 days of the original supply being provided, OTPs must document in the medical record the reason for the exception. HCPCS code G2216 (injectable naloxone) is contractor -priced for CY 2021. Patients may be appropriately given OUD services at more than one OTP within a 7 day period in certain limited clinical situations, such as for guest dosing or when a patient transfers care between OTPs. Each of the involved OTPs may bill the appropriate HCPCS codes for the services provided to the patient, but both OTPs must maintain sufficient medical record documentation to reflect the clinical situation and services provided. In instances in which a patient is switching from one drug to another, the OTP should only bill for one code describing a weekly bundled payment for that week and should determine which code to bill based on which drug was furnished for the majority of the week. 40.1 - Place of Service (Rev. 4524: Issued; 02- 14-20: Effective; 01 -01-20: Implementation: 03 -16-20) Claims for OTP services should use Place of Service code 58 (Non -residential Opioid Treatment Facility a location that provides treatment for OUD on an ambulatory basis. Services include methadone and other forms of MAT). 40.2 - Date of Service (Rev. 12418; Issued: 12- 21-23; Effective: 01 -01-24; Implementation: 01- 24-24) For the codes that describe a weekly bundle (HCPCS codes G2067- G2075) as well as HCPCS code G0137, one week is defined as 7 contiguous days. OTPs may choose to apply a standard billing cycle by setting a particular day of the week to begin all episodes of care. In this case, the date of service would be the first day of the OTPs billing cycle. If a beneficiary starts treatment at the OTP on a day that is in the middle of the OTPs standard weekly billing cycle, the OTP may still bill the applicable code for that episode of care provided that the threshold to bill for the code has been met. Alternatively, OTPs may choose to adopt weekly billing cycles that vary across patients. Under this approach, the initial date of service will depend upon the day of the week when the patient was first admitted to the program or when Medicare billing began. Therefore, under this approach of adopting weekly billing cycles that vary across patients, when a patient is beginning treatment or re -starting treatment after a break in treatment, the date of service would reflect the first day the patient was seen and the date of service for subsequent consecutive episodes of care would be the first day after the previous 7- day period ends. For the codes describing add- on services (HCPCS codes G2076- G2080, and G0137), the date of service should reflect the date that service was furnished; however, if the OTP has chosen to apply a standard weekly billing cycle, the date of service for codes describing add -on services may be the same as the first day in the weekly billing cycle. 40.3 - Prescribing Individuals (Rev. 4524: Issued; 02- 14-20: Effective; 01 -01-20: Implementation: 03 -16-20) OTPs should list the prescribing or medication ordering physicians or other eligible professionals National Provider Identifier in Field 17 (the ordering/referring/other field) of the Form CMS 1500 (Health Insurance Claim Form; 0938 1197) or the digital equivalent thereof. 50 Institutional Opioid Treatment Program (OTP) Services A/B MAC (A) (Rev. 10521; Issued: 12- 16-20; Effective: 01 -01-21; Implementation: 01 -04-21) Medicare Part B coverage is available for outpatient Opioid Treatment Program services provided by hospitals, CAHs, and Free -Standing Opioid Treatment Program facilities. 50.1 Special Opioid Treatment Program Billing Requirements for Hospitals, Critical Access Hospitals, and Free -Standing Opioid Treatment Program Facilities (Rev. 10521; Issued: 12- 16-20; Effective: 01 -01-21; Implementation: 01 -04-21) Medicare Part B coverage is available for hospital outpatient Opioid Treatment Program services. A. Billing Requirement Section 1861(s)(2)(HH)(jjj) of the Act requires that opioid use disorder treatment services would include the Food and Drug Administration (FDA)-approved opioid agonist and antagonist treatment medications, the dispensing and administration of such medicat ions (if applicable), substance use disorder counseling, individual and group therapy, toxicology testing, and other items and services that the Secretary determines are appropriate. Section 1861(s)(2)(HH)(jjj) defines OTPs as those that enroll in Medicare and are certified by the Substance Abuse and Mental Health Services Administration (SAMHSA), accredited by a SAMHSA -approved entity, and meet additional conditions as the Secretary finds necessary to ensure the health and safety of individuals being furni shed services under these programs and the effective and efficient furnishing of such services.

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50.1 Special Opioid Treatment Program Billing Requirements for Hospitals, Critical Access Hospitals, and Free -Standing Opioid Treatment Program Facilities (Rev. 10521; Issued: 12- 16-20; Effective: 01 -01-21; Implementation: 01 -04-21) Medicare Part B coverage is available for hospital outpatient Opioid Treatment Program services. A. Billing Requirement Section 1861(s)(2)(HH)(jjj) of the Act requires that opioid use disorder treatment services would include the Food and Drug Administration (FDA)-approved opioid agonist and antagonist treatment medications, the dispensing and administration of such medicat ions (if applicable), substance use disorder counseling, individual and group therapy, toxicology testing, and other items and services that the Secretary determines are appropriate. Section 1861(s)(2)(HH)(jjj) defines OTPs as those that enroll in Medicare and are certified by the Substance Abuse and Mental Health Services Administration (SAMHSA), accredited by a SAMHSA -approved entity, and meet additional conditions as the Secretary finds necessary to ensure the health and safety of individuals being furni shed services under these programs and the effective and efficient furnishing of such services. Hospitals and CAHs report condition code 89 in FLs 18-28 (or electronic equivalent) to indicate the claim is for Opioid Treatment Program services. They must also report a revenue code and the charge for each individual covered service furnished. In additi on, hospital outpatient departments are required to report HCPCS codes. CAHs are not required to report HCPCS code for this benefit. Under component billing, hospitals are required to report a revenue code and the charge for each individual covered service furnished under an opioid treatment program. In addition, hospital outpatient departments are required to report HCPCS codes. Component billing assures that only those opioid treatment program services covered under 1861(s)(2)(HH)(jjj) of the Act are paid by the Medicare program. All hospitals are required to report condition code 89 in FLs 18-28 to indicate the claim is for opioid treatment program services. Hospitals use bill type 013X and CAHs use bill type 085X. The following special procedures apply: Bills must contain an acceptable revenue code. They are as follows: Revenue Code Description 0636 Drugs Requiring Detailed Coding 0900 Behavioral Health Treatment/Services 0914 Individual Therapy 0915 Group Therapy 0916 Family Therapy 0918 0919 0940 0944 Behavioral Health/Testing Other Behavioral Health Treatments General Classification Drug Rehabilitation 0949 0953 Other Therapeutic Service Chemical Dependency (Drug and Alcohol) Hospitals other than CAHs are also required to report appropriate HCPCS codes. Edit to assure that HCPCS are present when the above revenue codes are billed and that they are valid HCPCS codes. Do not edit for the matching of revenue code to HCPCS. NOTE : Information regarding the Form CMS -1450 form locators that correspond with these fields is found in Chapter 25 of this manual. See the ASC X12 837 Institutional Claim implementation guide for related guidelines for the electronic claim. B. Reporting of Service Units Hospitals and Free -Standing facilities report the number of times the service or procedure, as defined by the HCPCS code, was performed. NOTE : Service units are not required to be reported for drugs and biologicals (Revenue Code 250). C. Line Item Date of Service Reporting Hospitals other than CAHs are required to report line item dates of service per revenue code line for opioid treatment program claims. This means each service (revenue code) provided must be repeated on a separate line item along with the specific date the service was provided for every occurrence. Line item dates of service are reported in FL 45 Service Date (MMDDYY). D. Special Requirements for Free-Standing Opioid Treatment Program Facilities Section 1833 (s)(2)(HH)(jjj))) of the Act recognizes Free -Standing Opioid Treatment Program Facilities as providers of services but only for furnishing Opioid Treatment Program services. Applicable provider ranges are xx9900-xx9999 billed on a claim with a type of bill 087x. Other billing requirements (except condition code 89 reporting) mentioned above for hospitals apply. E. Payment Section 1861 (s)(2)(HH)(jjj )) of the Act provides the statutory authority governing payment for opioid treatment program services provided by a hospital or free -standing facility. A/B MAC(s) (A) make payment on a fee schedule basis (see 30.8). CAHs are paid at reasonable cost bas is. The Part B deductible applies. There is no PC/TC split for OTP billing. Only one (1) provider may bill for the services of the opioid treatment program, either the facility or the practitioner, but not both. F. Data for CWF and PS&R Include revenue codes, HCPCS/CPT codes, units, and covered charges in the financial data section (fields 65a - 65j), as appropriate. Report the billed charges in field 65h, "Charges," of the CWF record. Include in the financial data portion of the PS&R UNIBILL, revenue codes, HCPCS/CPT codes, units, and charges, as appropriate. G. Medical Review The A/B MACs (A) follow medical review guidelines in Pub. 100-08, Medicare Program Integrity Manual. Transmittals Issued for this Chapter Rev # Issue Date Subject Impl Date CR# R12418CP 12/21/2023 Updates to Medicare Benefit Policy Manual and Medicare Claims Processing Manual for Opioid Treatment Programs (OTPs) 01/24/2024 13470 R11792CP 01/19/2023 Updates to Medicare Benefit Policy Manual and Medicare Claims Processing Manual for Opioid Treatment Programs and Additional Claims Modifier for Audio -only Services 02/21/2023 13062 R11219CP 01/27/2022 Updates to Medicare Benefit Policy Manual and Medicare Claims Processing Manual for Opioid Treatment Programs and New Modifier for Audio- only Services 03/01/2022 12545 R10665CP 03/16/2021 Updates to Medicare Benefit Policy Manual and Medicare Claims Processing Manual for Opioid Treatment Programs (Manual Updates Only) 04/15/2021 12161 R10521CP 12/16/2020 New Medicare National Uniform Billing Committee (NUBC) Type of Bill (TOB), Condition Code and implementing Billing Codes for Opioid Treatment Programs 01/04/2021 11856 08/06/2020 New Medicare National Uniform Billing Committee (NUBC) Type of Bill (TOB), Condition Code and implementing Billing Codes for Opioid Treatment Programs Rescinded and replaced by transmittal 10521 01/04/2021 11856 02/14/2020 Update to Medicare Benefit Policy Manual and Medicare Claims Processing Manual Adding New Chapters for Opioid Treatment Programs (Manual Updates Only 03/16/2020 11620 Back to Top of Chapter