Required Billing and Coding
J Code Product Indications
J1439 Injection, ferric carboxymaltose, 1 mg
L34093 (Chemotherapy and Biologicals)
J0887 - Injection, Epoetin Beta (For ESRD On Dialysis), 1 microgram
Q9976 - Injection ferric pyrophosphate citrate solution; 0.1 mg of iron
INDICATIONS
Injectafer® (ferric carboxymaltose injection) is indicated for the treatment of iron deficiency anemia (IDA) in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron, or who have non-dialysis dependent chronic kidney disease.
WARNINGS AND PRECAUTIONS
Symptomatic hypophosphatemia requiring clinical intervention has been reported in patients at risk of low serum phosphate in the postmarketing setting. These cases have occurred mostly after repeated exposure to Injectafer in patients with no reported history of renal impairment. Possible risk factors for hypophosphatemia include a history of gastrointestinal disorders associated with malabsorption of fat-soluble vitamins or phosphate, concurrent or prior use of medications that affect proximal renal tubular function, hyperparathyroidism, vitamin D deficiency and malnutrition. In most cases, hypophosphatemia resolved within three months.
Monitor serum phosphate levels in patients at risk for low serum phosphate who require a repeat course of treatment.
Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Injectafer. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Injectafer administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Injectafer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. In clinical trials, serious anaphylactic/anaphylactoid reactions were reported in 0.1% (2/1775) of subjects receiving Injectafer. Other serious or severe adverse reactions potentially associated with hypersensitivity which included, but were not limited to, pruritus, rash, urticaria, wheezing, or hypotension were reported in 1.5% (26/1775) of these subjects.
Billing and coding
Important information related to Injectafer reimbursement Proper billing and coding can help ensure eligible patients receive the proper program support. The following codes may be helpful to facilitate Injectafer reimbursement. The completion and submission of coverage-related documentation are the responsibility of the patient and healthcare provider.
Injectafer® (ferric carboxymaltose injection) is indicated for the treatment of IDA in adult patients:
• who have intolerance to or have had unsatisfactory response to oral iron or
• who have non-dialysis dependent chronic kidney disease
Product-Specific Billing Code
HCPCS J1439 Injection, ferric carboxymaltose 1 mg
Overview
Iron is a critical structural component of hemoglobin, a key protein found in normal red blood cells (RBCs) which transport oxygen. Without this important building block, anemic patients experience difficulty in restoring adequate, healthy RBCs that improve hematocrit levels. Iron deficiency is a common condition in end stage renal disease (ESRD) patients undergoing hemodialysis. Clinical management of iron deficiency involves treating patients with iron replacement products while they undergo hemodialysis. The available evidence suggests that the mode of intravenous administration is perhaps the most effective treatment for iron deficiency in hemodialysis patients. Unlike oral iron products, which must be absorbed through the GI tract, IV iron products are infused directly into the bloodstream in a
form that is readily available to the bone marrow for RBC synthesis, resulting in an earlier correction of iron deficiency and anemia.
Coverage also includes the medically necessary and reasonable use of parenteral iron preparations in non-dialysis related clinical conditions.
Guidelines
Medicare covers Sodium Ferric Gluconate Complex in Sucrose Injection as a first line treatment of Iron Deficiency Anemia when furnished intravenously to patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy.
Medicare also covers Iron Sucrose Injection as a first line treatment of Iron Deficiency Anemia when furnished intravenously to patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy.
Coverage also includes for parenteral iron in iron deficiency anemia:
• For patients with iron deficiency anemia who do not respond to oral iron supplementation due to malabsorption disorders or patients who have documented intolerance to oral iron supplementation.
• For anemia related to chronic kidney disease.
• Initial treatment of absolute iron deficiency in patients receiving myelosuppressive chemotherapy who have asymptomatic anemia and risk factors for the development of symptomatic anemia requiring transfusion.
For the pregnant beneficiary when iron stores are depleted such that the mother and/or the fetus are at risk of adverse outcomes and oral iron replenishment is either not tolerated or the anemia is of such severity as to require more immediate replenishment. Additionally, use in the peripartum period may be indicated when intra/post-partum hemorrhage is severe and by administering parenteral iron a transfusion may be avoided. This indication does not replace the strong consideration for transfusions when the hemorrhage is potentially life threatening.
APPLICABLE CODES
The following list(s) of codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this guideline does not imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or
guarantee claim payment. Other Policies and Guidelines may apply.
PURPOSE
The Medicare Advantage Policy Guideline documents are generally used to support UnitedHealthcare Medicare Advantage claims processing activities and facilitate providers’ submission of accurate claims for the specified services. The document can be used as a guide to help determine applicable:
• Medicare coding or billing requirements, and/or
• Medical necessity coverage guidelines; including documentation requirements.
UnitedHealthcare follows Medicare guidelines such as LCDs, NCDs, and other Medicare manuals for the purposes of determining coverage. It is expected providers retain or have access to appropriate documentation when requested to support coverage. Please utilize the links in the References section below to view the Medicare source materials used to develop this resource document. This document is not a replacement for the Medicare source materials that outline Medicare coverage requirements. Where there is a conflict between this document and Medicare source materials, the Medicare source materials will apply.
A. Background: Section 153(b) of the Medicare Improvements for Patients and Providers Act (MIPPA) required the implementation of an ESRD PPS effective January 1, 2011. The ESRD PPS provides a single payment to ESRD facilities that covers all of the resources used in furnishing an outpatient dialysis treatment. The ESRD PPS includes consolidated billing requirements for limited Part B services included in the ESRD facility’s bundled payment. The Centers for Medicare & Medicaid Services (CMS) periodically update the lists of items and services that are subject to Part B consolidated billing (CB) and are therefore no longer separately payable when provided to ESRD beneficiaries by providers other than ESRD facilities.
The ESRD PPS provides outlier payments, if applicable, for high cost patients due to unusual variations in the type or amount of medically necessary care.
B. Policy: This change request (CR) provides instructions for new codes added to the Healthcare Common Procedure Coding System (HCPCS) file for anemia management and therefore will be added to the list of items and services subject to the ESRD PPS consolidated billing (CB) requirements.
1. J0887 - Injection, Epoetin Beta (For ESRD On Dialysis), 1 microgram
2. J1439 - Injection, ferric carboxymaltose, 1mg
3. Q9976 - Injection ferric pyrophosphate citrate solution; 0.1 mg of iron
Anemia management is a category of drugs and biologicals that are always considered to be used for the treatment of ESRD. ESRD facilities will not receive separate payment for J0887, J1439, or Q9976 with or without the AY modifier and the claims shall process the line item as covered with no separate payment under the ESRD PPS.
Q9976 is administered via dialysate. Therefore, when billing for Q9976, it should be accompanied by the JE modifier as discussed in CR 8256 issued April 26, 2013.
In accordance with 42 CFR 413.237(a)(1), HCPCS J0887, J1439, and Q9976 are considered to be eligible outlier services and will be included in the outlier calculation when CMS provides a fee amount on the Average Sales Price fee schedule.
There is a new HCPCS J0888 for epoetin beta for non-ESRD use. This code will not be permitted on the ESRD type of bill 072x.
Lastly, Q2047 was terminated effective January 1, 2013 and is therefore no longer subject to the ESRD PPS consolidated billing requirements. In addition, J0890 is a recalled drug and should not be furnished to ESRD patients, therefore effective July 1, 2015, we are removing this code from the list of items and services that are subject to consolidated billing requirements.
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