Special Billing and Payment Requirements for A/B MACs (A)

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 stay, 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 Medicare’s 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-sponsored clinical trial, and when billed on type of bill 13X or 85X. All other normal inpatient billing practices apply.