HCPCS Codes, Level II: Drug Code for Venofer
HCPCS codes are used to identify most drugs and biologics. Venofer® (iron sucrose) injection, USP has been assigned the following drug-specific HCPCS code (also known as a J-code):
J1756 Injection, Iron Sucrose, 1 mg - Drug code Venofer
J2916 Injection, Sodium Ferric Gluconate Complex in Sucrose Injection, 12.5 mg (Ferrlecit®
Each 1 mg of Venofer is equivalent to one (1) service unit. When billing for quantities greater than 1 mg, indicate the total amount used as a multiple of service units on the claim form. Service units are very important and must be included on every claim. Here are some Venofer examples:
• One (1) vial (2.5 mL) or 50 mg = 50 service units
• One (1) vial (5 mL) or 100 mg = 100 service units
• One (1) vial (10 mL) or 200 mg = 200 service units
Medicaid
Medicaid may also cover Venofer when it is used for its FDA-approved indications. Medicaid patient eligibility guidelines and coverage policies vary from state to state, and some states maintain mandatory review criteria for including a product as an approved drug or service. Medicaid programs may base their coverage guidelines on Medicare or commercial payers or have more restrictive coverage. Most Medicaid programs in 2020 require prior authorization for branded drugs like Venofer.
III. Coding
Proper coding of services is key to your success in terms of billing for Venofer® (iron sucrose) injection, USP given in your office or clinic. Why is coding so crucial? Codes are simply an abbreviated way of describing the appropriateness and medical necessity of treatments given in your facility. This is what codes describe, in a nutshell:
• ICD-10-CM/diagnosis codes
show medical necessity of Venofer in terms of the reason for giving it
• CPT (HCPCS Level I) codes
demonstrate how Venofer was given to the patient
• HCPCS Level II codes
provide evidence of the type of drug and how much of it was given or wasted
More details are documented below.
A. International Classification of Disease, 10th Edition, Clinical Modification (ICD-10-CM) Diagnosis Coding for Venofer
ICD-10-CM diagnosis codes identify the patient’s diagnosis and inform insurers of why a service was provided. It should be simple, but it can get difficult with Venofer. First of all, there is a coding guideline that states, “Certain conditions have both an underlying etiology and multiple body system manifestations due to the underlying etiology. For such conditions, the ICD-10-CM has a coding convention that requires the underlying condition be sequenced first, if applicable, followed by the manifestation.”5 On the Venofer package insert, the indication is for iron deficiency anemia in chronic kidney disease. So, per coding guidelines, the chronic kidney disease is the underlying condition (etiology), and the resulting condition (manifestation) is the iron deficiency anemia. Therefore, it is very important that 2 codes are billed—the one for CKD and the one for iron deficiency anemia.
Venofer is approved for the treatment of iron deficiency anemia in adult patients with CKD. In addition, it is also approved for maintenance therapy in pediatric (greater than 2 years of age) hemodialysis patients with IDA, whether or not they are on ESA therapy. Venofer is also approved for maintenance therapy in pediatric (greater than 2 years of age) non-dialysis and peritonealdialysis patients with IDA who are on ESA therapy. American Regent makes no representation that Venofer is safe and effective in other patients or that it is permissible or legal to use for other indications.
General Guidelines
Understanding today’s complex world of healthcare reimbursement requires a good sense of direction. Even though Venofer® (iron sucrose) injection, USP has been in the marketplace since the year 2000 as a trusted iron product, the reimbursement landscape changes daily. Constant shifts in Medicare rules, payer policies, billing edits (eg, Medically Unlikely Edits), and medical coding are reasons to refer to this guide, whether you have billed for Venofer once or a hundred times.
Caring for patients with chronic kidney disease (CKD) requires that providers work closely with third-party payers to ensure that they are paid fully and fairly
for medically necessary healthcare items and services. American Regent, the manufacturer of Venofer, wants prescribing providers to better understand the complexities of reimbursement. The company has prepared this guide to assist you with common questions about Venofer and its reimbursement.
This guide provides general coverage, coding, and updated payment information about Venofer to help you better understand the policies of the Medicare program and other third-party payers. The guide should also help you avoid troublesome denials based on real-world data. The goal is to help you get paid fully and fairly for every claim.
If you need more help, American Regent’s VenAccess™ Reimbursement Hotline is available to provide assistance and to answer all of your payment questions.
This hotline can be reached by calling 877-4-IV-IRON (877-448-4766), Monday through Friday, between 9 am and 8 pm ET.
II. Coverage
For those of you who are newer to billing, coverage refers to 2 things. First, coverage is contingent upon whether the patient’s policy covers a particular aspect of care. For example, if a patient has major medical coverage without prescription coverage, self-administered (prescription) drugs probably will not be covered under that benefit. But non-self-administered (“buy-and-bill”) drugs, like Venofer® (iron sucrose) injection, USP, will be covered in a doctor’s office or hospital outpatient setting under the major medical benefit as long as certain parameters are met, as described in the next paragraph.
The second aspect of coverage is whether a particular payer, per their own policies, will cover a particular item or service. Generally, a drug is covered if it is FDA-approved, given for the diagnoses that the FDA approved it for, and administered per the package insert, which is an outline of what the FDA approved for that drug. Added to that, the drug must be necessary and appropriate for a specific patient, which means that the patient must have the correct diagnosis and be eligible, in terms of health status, to receive the product. Both public and private payers may modify or widen this coverage by issuing policies that specify how and when they will cover a product like Venofer.
Medicare Coverage
Medicare is likely to cover Venofer and its administration when used for its FDA- approved indication and when administered per its package insert. Venofer is approved for the treatment of iron deficiency anemia (IDA) in adult patients with CKD. Under Medicare Part B (the doctor’s office), it must be given incident to a provider’s service. In order to meet all the general requirements for coverage under the incident-to provision, an FDA-approved drug or biologic must be: a) of a form that is not usually self-administered; b) furnished by a physician practice; and c) administered by the physician or by auxiliary personnel employed by the physician and under the physician’s personal supervision.1
The charge, if any, for the drug or biologic must be included in the physician’s bill, and the cost of the drug or biologic must represent an expense to the physician. Drugs and biologics furnished by other health professionals (nurse practitioners, physician assistants, and clinical nurse specialists with Medicare billing capability) may also meet these requirements. (See sections 170, 180, 190, and 200 in Chapter 15 of the Medicare Benefit Policy Manual for specific instructions.)1
In addition, Venofer® (iron sucrose) injection, USP is approved for maintenance therapy in pediatric (greater than 2 years of age) hemodialysis patients with iron deficiency anemia, whether or not they are on erythropoietin-stimulating agent (ESA) therapy. Venofer is also approved for maintenance therapy in pediatric (greater than 2 years of age) non-dialysis and peritoneal-dialysis patients with iron deficiency anemia who are on ESA therapy. Patients on dialysis are covered by a separate benefit under Medicare Part A. Additionally, the Medicare rules for dialysis facilities include bundled payments. The bundled per-treatment payment includes drugs, laboratory services, supplies, and capital-related costs related to furnishing maintenance dialysis. So, Venofer may be covered but not paid for separately in dialysis facilities.2
Additionally, for dialysis patients, there is a National Coverage Determination by Medicare, which takes precedence over local intermediary decisions. The National Coverage Determination states, “Effective October 1, 2001, 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.”3
For non-dialysis patients, Medicare Part B coverage may be determined by local carriers or Medicare Administrative Contractors (MACs), who are responsible for issuing local coverage determinations (LCDs) that detail coverage guidelines.4
Additionally, carriers and MACs are responsible for processing Medicare claims. Prior authorization (PA) is not required under Part B. Also, Medicare coverage policies must be drafted and approved by a group of clinicians in your area called the Carrier Advisory Council (CAC). This body gives the public a voice in Medicare policy. Please see the CMS.gov website (link below) for more information.*
Commercial Payers and Medicare Advantage
Medicare Part C is called Medicare Advantage (MA) and currently covers approximately 36.5% of Medicare patients. MA plans are private plans that must cover the same breadth of services that traditional Medicare does. But, other than that, MA behaves like a commercial payer and not like Medicare in terms of coverage and payment. Almost all private payers these days, including MA, require prior authorization for branded drugs like Venofer® (iron sucrose) injection, USP. This will tell you definitively whether a commercial plan will cover Venofer for your patient.
Frequent benefit investigation (sometimes known as insurance verification) is necessary for commercial patients—particularly if they are Affordable Care Act (ACA) patients with premiums or are on employer-based insurance. If patients do not pay premiums or they change jobs, this can impact insurance coverage. Healthcare insurance policies also have various levels of coverage and may have “caps” for drugs. This needs to be ascertained for each policy. Additionally, commercial payers often publish policies regarding iron products like Venofer. You should check the payer policies for Venofer each time you infuse a patient and each time you initiate a new course of iron treatment with Venofer. You can also verify how a policy applies to your patient at the time of prior authorization.
National Drug Codes (NDCs)
National Drug Codes are becoming more prevalent in billing for drugs. Many plans now require NDCs on every claim. The most prominent payers to require NDCs are UnitedHealthcare and all Medicaid plans.
The NDC for Venofer (and all drugs) should be applied to the claim in a 5-4-2 format, meaning that there should be 5 digits, then 4 digits, then 2 digits on the claim, like this:
Venofer is preservative free and available as 50 mg/2.5 mL single-use vials, 100 mg/ 5 mL single-use vials, and 200 mg/10 mL single-use vials. The NDC numbers are:
Drug Payment in the Hospital Outpatient Department
Medicare
Under the Hospital Outpatient Prospective Payment System (HOPPS), drugs and biologics have different payments throughout their product life cycle. Older drugs, like Venofer, that are more than 2 to 3 years after launch, receive either packaged payment or separate payment through their own Ambulatory Payment Classification (APC). The APC is a payment grouping used for hospital outpatient claims as well as ambulatory surgical center (ASC) claims. Each APC group is assigned a preset payment amount, which is intended to cover the hospital’s costs related to the item or service provided. This method of payment ONLY applies to fee-for-service Medicare beneficiaries—not those enrolled in Medicare Advantage Plans.
Some drugs, like Venofer, are packaged based upon a daily predetermined per-encounter rate. That is, if the drug’s per-encounter cost is less than the predetermined threshold, the drug is packaged into the APC of the drug administration for that Venofer encounter.
Medicare groups CPT and HCPCS codes for Venofer® (iron sucrose) injection, USP administration into the corresponding APCs for payment and, thereby, does not pay separately for it. It becomes part of the APC payment for the administration. The following CPT codes may be used to bill for the administration of Venofer and are assigned to each corresponding APC group for the calendar year 2020:
Denials
All provider-administered (“buy-and-bill”) drugs have complicated payment scenarios based on cost and various payer coverage policies. Moreover, for nonTraditional Medicare payers, prior authorization is needed for all branded drugs, like Venofer® (iron sucrose) injection, USP, to be paid. Thus, denials are common and create much follow-up for providers. Venofer is no exception; however, some of its denials are unique to its indication of iron deficiency anemia in chronic kidney disease. A Clearinghouse database* evidences the following top 5 denial codes for Venofer in 2019, an explanation as to why these may be happening, and how these may be prevented in the buy-and-bill setting
Claim Denial Code #50, Lack of Medical Necessity: This denial code seems to imply that payers are not covering Venofer because the reasons for the administration are not covered. However, in looking at the data, most claims denied under this denial code are not coded correctly in terms of their diagnosis. The top denied ICD-10-CM diagnosis code is D50.9, “unspecified anemia.” Unspecified codes for drugs are very often denied. It is important to use the most specific code that matches individual record documentation. Further, it is also vital to check all individual payer policies for coding guidance and, if they are not available, review the applicable ICD10-CM guidelines to choose the optimal code for payment of Venofer.
Claim Denial Code #11, The Procedure Code and Diagnosis Code Do Not Match: This denial means that the payer expects to see a different diagnosis with the Venofer® (iron sucrose) injection, USP HCPCS code. Again, unspecified codes are a problem, as they are codes that do not convey the diagnosis on the Venofer package insert. Further, there are some claims for diagnoses that are not indicated for Venofer. Please verify coverage and coding guidelines prior to administration of Venofer.
If you receive a Venofer denial and have questions about it, please call the VenAccess™ Reimbursement Hotline at 877-4-IV-IRON (877-448-4766), Monday through Friday, between 9 am and 8 pm ET.
American Regent has established a toll-free hotline to help physicians and other providers understand payers’ coverage and reimbursement policies for Venofer® (iron sucrose) injection, USP, and when necessary, address reimbursement issues. Specifically, on a limited basis, hotline reimbursement specialists can assist with the following:
• Insurance verifications: Help callers verify payer coverage and reimbursement policies for Venofer. Reimbursement specialists will determine patient benefit levels and discuss potential billing options with patient consent
• Billing assistance: Assist callers with filing claims and understanding the reimbursement policies for Venofer
• Claims appeals: Support callers in appealing denied claims or inadequate reimbursement for Venofer
• Patient assistance: Screen individuals without health insurance who are ineligible for public assistance for enrollment in a product replacement program
Patient information will be kept strictly confidential at all times. Every attempt is made to provide accurate, up-to-date information. The Venofer Reimbursement Hotline cannot guarantee successful reimbursement. To speak with someone at American Regent’s Customer Service or Medical Affairs department, please call 800-645-1706.
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.
HCPCS Code Description
J1756 Injection, Iron Sucrose, 1 mg (Venofer®)
J2916 Injection, Sodium Ferric Gluconate Complex in Sucrose Injection, 12.5 mg (Ferrlecit®)
http://www.cms1500claimbilling.com/2021/03/cpt-code-venofer-j1756.html