(Medicare Claims Processing Manual)

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)