(Medicare Claims Processing Manual)

ICD- 10-CM Applicable   any anemia in cancer or cancer treatment patients due to folate deficiency - (D52.0, D52.1, D52.8, or D52.9),   B-12 deficiency - (D51.1, D51.2, D51.3, D51.8, D51.9, or D53.1),   iron deficiency -  (D50.0, D50.1, D50.8, and D50.9),  hemolysis -  (D55.0, D55.1, D58.0, D58.9, D59.0, D59.1, D59.2, D59 4, D59.5, D59.6, D59.8, or D59.9),   bleeding -  (D50.0, D62),   anemia associated with the treatment of acute and chronic myelogenous leukemias (CML, AML) - (C92.00, C92.01, C92.02, C92.10, C92.11, C92.12, C92.20, C92.21, C92.40, C92.41, C92.42, C92.50, C92.51, C92.52, C92.60, C92.61, C92.62, C92.90, C92.91, C92.A0, C92.A1, C92.A2, C92Z0, C92Z1, or C92Z2), or   erythroid cancers - (C94.00, C94.01, C94.02, C94.20, C94.21, C94.22, C94.30, C94.31, C94.80, C94.81, D45).   Effective for claims with dates of service on and after January 1, 2008, contractors shall deny non- ESRD ESA services for HCPCS J0881 or J0885 billed with modifier EC (ESA, anemia, non- chemo/radio) for:    any anemia in cancer or cancer treatment patients due to bone marrow fibrosis,  anemia of cancer not related to cancer treatment,   prophylactic use to prevent chemotherapy -induced anemia,   prophylactic use to reduce tumor hypoxia,  patients with erythropoietin -type resistance due to neutralizing antibodies; and  anemia due to cancer treatment if patients have uncontrolled hypertension.   Effective for claims with dates of service on and after January 1, 2008, non- ESRD ESA services for HCPCS J0881 or J0885 billed with modifier EB (ESA, anemia, radio-induced), shall be denied.  Effective for claims with dates of service on and after January 1, 2008, contractors shall deny non- ESRD ESA services for HCPCS J0881 or J0885 billed with modifier EA (ESA, anemia, chemo -induced) for anemia secondary to myelosuppressive anticancer chemothe rapy in solid tumors, multiple myeloma, lymphoma, and lymphocytic leukemia when a hemoglobin 10.0g/dL or greater or hematocrit 30.0% or greater is reported.   NOTE:   ESA treatment duration for each course of chemotherapy includes the 8 weeks following the final dose of myelosuppressive chemotherapy in a chemotherapy regime.    Effective for claims with dates of service on and after January 1, 2008, Medicare contractors shall have discretion to establish local coverage policies for those indications not included in NCD 110.21.  Denials of claims for ESAs are based on reasonable and necessary determinations established by NCD 110.21.  A provider may have the beneficiary sign an Advanced Beneficiary Notice, making the beneficiary liable for services not deemed reasonable and necess ary and thus not covered by Medicare.   The contractor shall use the following remittance advice messages and associated codes when rejecting/denying claims under this policy. This CARC/RARC combination is compliant with CAQH CORE Business Scenario Three.   Group Code: PR or CO  CARC: 50  RARC: N/A  MSN: 15.20  Medicare contractors have the discretion to conduct medical review of claims and reverse the automated adjudication if the medical review results in a determination of clinical necessity.   80.13  Supplier Payment Under Medicare Part B for Insulin Furnished Through Durable Medical Equipment                                                      (Rev. 12013; Issued: 05- 02-23; Effective: 07 -01-23; Implementation: 07 -03-23)  For insulin administered through an item of DME see Pub. 100- 04 Chapter 20,  Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS), Section 140.1.1 for further instruction.   90 - Claims Processing Rules for Hospital Outpatient Billing and Payment  (Rev. 1, 10- 01-03)  90.1 - Blood/Blood Products and Drugs Classified in Separate APCs for Hospital Outpatients  (Rev. 496, Issued: 03- 04-05, Effective: 07 -01-05, Implementation: 07- 05-05)  Proper Billing for Blood Products and Blood Storage and Processing  Refer to Pub.100- 04, Medicare Claims Processing Manual, Chapter 4, 231 regarding billing for blood and blood products under the Hospital Outpatient Prospective Payment System (OPPS).       90.2 - Drugs, Biologicals, and Radiopharmaceuticals  (Rev. 4204, Issued: 01- 17-19, Effective: 01 -01-19, Implementation: 01- 07-19)   A. General Billing and Coding for Hospital Outpatient Drugs, Biologicals, and Radiopharmaceuticals   Hospitals should report charges for all drugs, biologicals, and radiopharmaceuticals, regardless of whether the items are paid separately or packaged, using the correct HCPCS codes for the items used.  It is also of great importance that hospitals billing for these products make certain that the reported units of service of the reported HCPCS code are consistent with the quantity of a drug, biological, or radiopharmaceutical that was used in the care of the patient.   Payment for drugs, biologicals and radiopharmaceuticals under the OPPS is inclusive of both the acquisition cost and the associated pharmacy overhead or nuclear medicine handling cost.  Hospitals should include these costs in their line -item charges for dr ugs, biologicals, and radiopharmaceuticals.  Under the OPPS, if commercially available products are being mixed together to facilitate their concurrent administration, the hospital should report the quantity of each product (reported by HCPCS code) used in the care of the patient.  Alternatively, if the hospital is compounding drugs that are not a mixture of commercially available products, but are a different product that has no applicable HCPCS code, then the hospital should report an appropriate unlisted drug code (J9999 or J3490).  In these situat ions, it is not appropriate to bill HCPCS code C9399.  HCPCS code C9399, Unclassified drug or biological, is for new drugs and biologicals that are approved by FDA on or after January 1, 2004, for which a specific HCPCS code has not been assigned.   The HCPCS code list of retired codes and new HCPCS codes reported under the hospital OPPS is published quarterly via Recurring Update Notifications.  The latest payment rates associated with each APC and HCPCS code may be found in the most current Addendum  A and Addendum B, respectively that can be found under the CMS quarterly provider updates on the CMS Web site at:   http://www.cms.gov/Medicare/Medicare -Fee-for-Service-Payment/HospitalOutpatientPPS/index.html   Future updates will be issued in a Recurring Update Notification.   B. Pass -Through Drugs, Biologicals, and Radiopharmaceuticals   Payment for drugs, biologicals, and radiopharmaceuticals may be made under the pass -through provision which provides additional payments for drugs, biologicals, and radiopharmaceuticals that meet certain requirements relating to newness and relative  costs.  According to section 1833(t) of the Social Security Act, transitional pass -through payments can be made for at least 2 years, but no more than 3 years.  For the process and information required to apply for transitional pass -through payment status for drugs, biologicals, and radiopharmaceuticals, go to the main OPPS Web page, currently at:   http://www.cms.gov/Medicare/Medicare -Fee-for-Service-Payment/HospitalOutpatientPPS/index.html to see the latest instructions.  ( NOTE:  Due to the continuing development of the new cms.hhs.gov Web site, this link may change.)  Payment rates for pass -through drugs, biologicals, and radiopharmaceuticals are updated quarterly.  The all -inclusive list of billable drugs, biologicals, and radiopharmaceuticals for pass -through payment is included in the current quarterly Addendum B.  The most current Addendum B can be found under the CMS quarterly provider updates on the CMS website.   C. Non Pass -Through Drugs and Biologicals   Under the OPPS, drugs and biologicals that are not granted pass -through status receive either packaged payment or separate payment.  Payment for drugs and biologicals with estimated per day costs equal to or below the applicable drug packaging threshold is  packaged into the payment for the associated procedure, commonly a drug administration procedure.  Drugs and biologicals with per day costs above the applicable drug packaging threshold are paid separately through their own APCs.   D. Radiopharmaceuticals   1. General   Beginning in CY 2008, the OPPS divides radiopharmaceuticals into two groups for payment purposes: diagnostic and therapeutic.  Diagnostic radiopharmaceuticals function effectively as products that enable the provision of an independent service, specificall y, a diagnostic nuclear medicine scan.  Therapeutic radiopharmaceuticals are themselves the primary therapeutic modality.   Beginning January 1, 2008, the I/OCE requires claims with separately payable nuclear medicine procedures to include a radiolabeled product (i.e., diagnostic radiopharmaceutical, therapeutic radiopharmaceutical, or brachytherapy source).  Hospitals are requ ired to submit the HCPCS code for the radiolabeled product on the same claim as the HCPCS code for the nuclear medicine procedure.  Hospitals are also instructed to submit the claim so that the services on the claim each reflect the date the particular ser vice was provided.  Therefore, if the nuclear medicine procedure is provided on a different date of service from the radiolabeled product, the claim will contain more than one date of service.  More information regarding these edits is available on the OPPS Web site at http://www.cms.gov/Medicare/Medicare -Fee-for-Service -Payment/HospitalOutpatientPPS/index.html   There are rare situations where a hospital provides a radiolabeled product to an inpatient, and then the patient is discharged and later returns to the outpatient department for a  nuclear medicine imaging procedure but does not require additional radiolabeled product.  In these situations, hospitals are to include HCPCS code C9898 (Radiolabeled product provided during a hospital inpatient stay) with a token charge (of less than $1.01) on the same claim as the nuclear medicine procedure in order to receive payment for the nuclear medicine procedure.  HCPCS code C9898 should only be reported under the circumstances described above, and the date of service for C9898 should be the same a s the date of service for the diagnostic nuclear medicine procedure.   2. Diagnostic Radiopharmaceuticals   Beginning in CY 2008, payment for nonpass -through diagnostic radiopharmaceuticals is packaged into the payment for the associated nuclear medicine procedure.   3. Therapeutic Radiopharmaceuticals